A Study to Investigate the Safety, Tolerability, and Pharmacokinetics (PK) of Oral AZD6793 in Healthy Subjects and to Assess the Relative Oral Bioavailability Between Two Formulations. The Study Will Also Assess the Food Effect on the PK of AZD6793 Compared to Fasting State

Study Overview
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Brief Summary
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The purpose of the study is to assess the safety and tolerability of AZD6793 suspension following oral administration of Single Ascending Dose (SAD) [Part 1] and Multiple Ascending Dose (MAD) [Part 2] in healthy subjects. Additionally, the study will include Part 3 (bioavailability and food effect cohort) to assess the relative oral bioavailability between film-coated tablet and oral suspension (reference formulation) as well as the effect of a high fat high calorie (HFHC) meal on the PK of AZD6793 film-coated tablet, in comparison to fasting conditions, after a single oral dose of AZD6793 in healthy subjects.

Detailed Description
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The study will be conducted at a single study centre and comprises of 3 parts. Parts 1, 2, and 3 will serve as SAD, MAD, bioavailability and food effect, respectively. Part 1 of the study will comprise: A Screening Period of maximum 28 days (Day -29 to Day -2) A Treatment Period during which subjects will be resident at the Clinical Unit from Day -1 (the day before IMP administration [Day 1]) until at least 72 hours after IMP administration. Subjects will then be discharged on Day 4 if in good health and after all samples have been collected. Depending on the emerging data, the length of the stay at the Clinical Unit may be changed. A Follow-up Visit within 6 ± 1 days after the IMP dose (this visit may be done later if indicated, for example, if emerging PK data indicates a longer AZD6793 half-life than was predicted). Part 2 of the study will comprise: A Screening Period of maximum 28 days (Day -29 to Day -2). A Treatment Period during which subjects will be resident at the Clinical Unit from Day -1 (the day before first IMP administration [Day 1]) until Day 10. Subjects will receive a single dose of IMP in the morning on Day 1. After a washout of at least 48 hours (depending on PK data from Part 1), subjects will be dosed twice daily (12 hours apart) from Day 3 through Day 7. Subjects will receive the last dose of IMP in the morning of Day 8. Subjects will then be discharged on Day 10 if in good health and after all samples have been collected. A Follow-up Visit within 6 ± 1 days after the last IMP dose (this visit may be done later if indicated, for example, if emerging PK data indicates a longer AZD6793 half-life than was predicted). Part 3 of the study will comprise: A Screening Period of maximum 28 days (Day -29 to Day -2). A Treatment Period during which subjects will be resident at the Clinical Unit from Day -1 until Day 3. Subjects will be randomised on Day 1 of Visit 3 to one of 3 treatment sequences and will receive AZD6793 on Day 1 of each treatment period. Dose administration will be separated by a washout period of at least 3 days from the previous IMP dose of each treatment period. A Follow-up Visit within 6 ± 1 days after the last IMP dose

Official Title
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A Blinded, Randomised, Placebo-controlled Study to Investigate the Safety, Tolerability, and Pharmacokinetics of an Oral Suspension of AZD6793 Following Single and Multiple Ascending Doses in Healthy Subjects, an Open-label Study to Assess the Relative Bioavailability and Food Effect of a Tablet Formulation of AZD6793 in Healthy Subjects and a Blinded, Randomised, Placebo-controlled Study to Investigate the Safety, Tolerability, and Pharmacokinetics of a Tablet Formulation of AZD6793 in Patients With Chronic Obstructive Pulmonary Disease

Conditions
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Inflammatory Diseases

Intervention / Treatment
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* Drug: AZD6793
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male or female subjects aged 18 to 55 years with suitable veins for cannulation or repeated venepuncture Females must have a negative pregnancy test must not be lactating and must be either (a) non-childbearing potential, confirmed by post-menopausal defined as amenorrhea for at least 12 months; documentation of irreversible surgical sterilisation or (b) childbearing potential, i.e., fertile, following menarche and until becoming post-menopausal unless permanently sterile (Must agree to use, with their partner, an approved method of highly effective contraception). Male subjects and their female partners of childbearing potential must be willing to use highly effective contraception measures and male subjects must refrain from donating sperm or fathering a child from the first day of dosing until 3 months after the last dose of IMP. Have a BMI between 18 and 30 kg/m2 inclusive and weigh at least 50 kg, at the Screening Visit. Exclusion Criteria: History or presence of gastrointestinal, hepatic, renal, pancreatic disease or acute disease in these organs. History of chronic haematologic disease. Diagnosis or history of immunodeficiency or increased susceptibility to severe infection, or a clinically significant infection Any clinically important illness, medical/surgical procedure or trauma within 4 weeks of the first administration of IMP. Parts 1 and 2 only: Positive or indeterminate QuantiFERON® Tuberculosis (TB) test at screening. Any clinically important abnormalities in clinical chemistry, haematology or urinalysis results Any positive result on Screening for serum Hepatitis B surface antigen (HBsAg), hepatitis C antibody and Human immunodeficiency virus (HIV). Any clinically important abnormalities in rhythm, conduction or morphology of the resting Electrocardiogram (ECG) and any clinically important abnormalities in the 12 lead ECG. Known or suspected history of alcohol and drug abuse in the last year. Current smokers or those who have smoked or used nicotine products (including e cigarettes) within the previous 3 months. History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity, or history of hypersensitivity to drugs with a similar chemical structure or class to AZD6793. Excessive intake of caffeine containing drinks or food Use of drugs with enzyme inducing properties such as St John's Wort within 3 weeks prior to the first administration of IMP. Use of any prescribed or nonprescribed medication including antacids, analgesics (other than paracetamol/acetaminophen), herbal remedies, mega dose vitamins (intake of 20 to 600 times the recommended daily dose) and minerals during the 2 weeks prior to the first administration of IMP or longer if the medication has a long half life Plasma donation within one month of the Screening Visit or any blood donation/blood loss > 500 mL during the 3 months prior to the Screening Visit. Parts 2 and 3 only: Subjects who have previously received AZD6793.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Subjects will be randomised to AZD6793 or placebo in a ratio of 6:2, such that for the first 2 subjects in each cohort, 1 subject will receive AZD6793, and 1 subject will receive placebo. After sentinel dosing, the remaining 6 subjects planned for the cohort will be randomised in a 5:1 ratio, so that 5 additional subjects in each cohort will receive AZD6793 and one additional subject will receive placebo. The study consists of 3 parts: Part 1 (SAD): In this part, healthy subjects will be randomised in 5 cohorts (may add up to 3 additional cohorts) to receive AZD6793 with 8 evaluable subjects in each cohort. Part 2 (MAD): In this part, healthy subjects will be randomised in 3 cohorts (may add up to 3 additional cohorts) to receive AZD6793 with 8 evaluable subjects in each cohort. Part 3 (Bioavailability and Food Effect Cohort): In this cohort, 15 healthy subjects will be randomised to receive AZD6793 with 12 evaluable subjects.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part 1 (SAD): Cohort 1<br>6 Healthy subjects will receive a single oral dose A of AZD6793 and 2 healthy subjects will receive placebo | Drug: AZD6793<br>* AZD6793 will be administered orally<br>Drug: Placebo<br>* Placebo will be administered orally<br>|
| Experimental: Part 1 (SAD): Cohort 2<br>6 Healthy subjects will receive a single oral dose B of AZD6793 and 2 healthy subjects will receive placebo | Drug: AZD6793<br>* AZD6793 will be administered orally<br>Drug: Placebo<br>* Placebo will be administered orally<br>|
| Experimental: Part 1 (SAD): Cohort 3<br>6 Healthy subjects will receive a single oral dose C of AZD6793 and 2 healthy subjects will receive placebo | Drug: AZD6793<br>* AZD6793 will be administered orally<br>Drug: Placebo<br>* Placebo will be administered orally<br>|
| Experimental: Part 1 (SAD): Cohort 4<br>6 Healthy subjects will receive a single oral dose D of AZD6793 and 2 healthy subjects will receive placebo | Drug: AZD6793<br>* AZD6793 will be administered orally<br>Drug: Placebo<br>* Placebo will be administered orally<br>|
| Experimental: Part 1 (SAD): Cohort 5<br>6 Healthy subjects will receive a single oral dose E of AZD6793 and 2 healthy subjects will receive placebo | Drug: AZD6793<br>* AZD6793 will be administered orally<br>Drug: Placebo<br>* Placebo will be administered orally<br>|
| Experimental: Part 2 (MAD): Cohort 1<br>6 Healthy subjects will receive dose W of AZD6793 and 2 healthy subjects will receive placebo once daily on Day 1 and 8 and twice daily on Day 3 to Day 7 | Drug: AZD6793<br>* AZD6793 will be administered orally<br>Drug: Placebo<br>* Placebo will be administered orally<br>|
| Experimental: Part 2 (MAD): Cohort 2<br>6 Healthy subjects will receive dose X of AZD6793 and 2 healthy subjects will receive placebo once daily on Day 1 and 8 and twice daily on Day 3 to Day 7 | Drug: AZD6793<br>* AZD6793 will be administered orally<br>Drug: Placebo<br>* Placebo will be administered orally<br>|
| Experimental: Part 2 (MAD): Cohort 3<br>6 Healthy subjects will receive dose Y of AZD6793 and 2 healthy subjects will receive placebo once daily on Day 1 and 8 and twice daily on Day 3 to Day 7 | Drug: AZD6793<br>* AZD6793 will be administered orally<br>Drug: Placebo<br>* Placebo will be administered orally<br>|
| Experimental: Part 2 (MAD) : Cohort 4<br>6 Healthy subjects will receive dose Z of AZD6793 and 2 healthy subjects will receive placebo once daily on Day 1 and 8 and twice daily on Day 3 to Day 7 | Drug: AZD6793<br>* AZD6793 will be administered orally<br>Drug: Placebo<br>* Placebo will be administered orally<br>|
| Experimental: Part 3: Treatment sequence 1<br>Subjects will receive a single oral dose of test formulation AZD6793 in fasted state, test formulation AZD6793 in fed state following reference formulation AZD6793 in fasted state once on Day 1 of each treatment period. | Drug: AZD6793<br>* AZD6793 will be administered orally<br>|
| Experimental: Part 3: Treatment sequence 2<br>Subjects will receive a single oral dose of test formulation AZD6793 in fed state, reference formulation AZD6793 in fasted state following test formulation AZD6793 in fasted state once on Day 1 of each treatment period. | Drug: AZD6793<br>* AZD6793 will be administered orally<br>|
| Experimental: Part 3: Treatment sequence 3<br>Subjects will receive a single oral dose of reference formulation AZD6793 in fasted state, test formulation AZD6793 in fasted state following test formulation AZD6793 in fed state once on Day 1 of each treatment period. | Drug: AZD6793<br>* AZD6793 will be administered orally<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Part 1 (SAD): Number of subjects with adverse events | Safety and tolerability of AZD6793 following oral administration of SAD in healthy subjects. | From screening up to Follow up visit (Day 6±1) | 
| Part 2 (MAD): Number of subjects with adverse events | Safety and tolerability of AZD6793 following oral administration of MAD in healthy subjects. | From screening up to Follow up visit (Day 14±1) | 
| Part 1 (SAD): Number of subjects with abnormal findings in vital signs (supine Blood Pressure (BP), pulse, respiratory rate, peripheral oxygen saturation (SpO2) and oral body temperature) | Safety and tolerability of AZD6793 following oral administration of SAD in healthy subjects. | From screening, Treatment Day 1 to Day 4 up to Follow up visit (Day 6±1) | 
| Part 2 (MAD): Number of subjects with abnormal findings in vital signs (supine Blood Pressure (BP), pulse, respiratory rate, peripheral oxygen saturation (SpO2) and oral body temperature) | Safety and tolerability of AZD6793 following oral administration of MAD in healthy subjects. | From screening, Treatment Day -1 to Day 10 up to Follow up visit (Day 14±1) | 
| Part 1 (SAD): Number of subjects with abnormal findings in 12 Lead electrocardiogram (ECG) | Safety and tolerability of AZD6793 following oral administration of SAD in healthy subjects. | From screening, Treatment Day -1 to Day 4 up to Follow up visit (Day 6±1) | 
| Part 2 (MAD): Number of subjects with abnormal findings in 12 Lead electrocardiogram (ECG) | Safety and tolerability of AZD6793 following oral administration of MAD in healthy subjects. | From screening, Treatment Day -1 to Day 10 up to Follow up visit (Day 14±1) | 
| Part 1 (SAD): Number of subjects with abnormal findings in 12 Lead Digital electrocardiogram (dECG) | Safety and tolerability of AZD6793 following oral administration of SAD in healthy subjects. | Day 1 to Day 3 | 
| Part 2 (MAD): Number of subjects with abnormal findings in 12 Lead Digital electrocardiogram (dECG) | Safety and tolerability of AZD6793 following oral administration of MAD in healthy subjects. | Day 1 to Day 3, Day 5, Day 8 to Day 10 | 
| Part 1 (SAD): Number of subjects with abnormal findings in Telemetry | Safety and tolerability of AZD6793 following oral administration of SAD in healthy subjects. | Day -1 to Day 3 | 
| Part 2 (MAD): Number of subjects with abnormal findings in Telemetry | Safety and tolerability of AZD6793 following oral administration of MAD in healthy subjects. | Day -1 to Day 2 and Day 8 to Day 10 | 
| Part 1 (SAD): Number of subjects with abnormal findings in Physical examinations | Safety and tolerability of AZD6793 following oral administration of SAD in healthy subjects. | From screening, Treatment Day -1 to 4 and follow up visit | 
| Part 2 (MAD): Number of subjects with abnormal findings in Physical examinations | Safety and tolerability of AZD6793 following oral administration of MAD in healthy subjects. | From screening, Treatment Day -1 to 10 and follow up visit | 
| Part 1 (SAD): Number of subjects with abnormal findings in Laboratory assessments (haematology, serum clinical chemistry, and urinalysis) | Safety and tolerability of AZD6793 following oral administration of SAD in healthy subjects. | From screening, Treatment Day -1, Day 2, Day 4 and Follow up visit (Day 6±1) | 
| Part 2 (MAD): Number of subjects with abnormal findings in Laboratory assessments (haematology, serum clinical chemistry, and urinalysis) | Safety and tolerability of AZD6793 following oral administration of MAD in healthy subjects. | From screening, Treatment Day -1 to Day 10 up to Follow up visit (Day 14±1) | 
| Part 3 (Bioavailability): Maximum observed plasma (peak) drug concentration [Cmax] | Evaluating the relative oral bioavailability between the test formulation and the reference formulation after a single oral dose of AZD6793 in healthy subjects. | Day 1 to Day 3 | 
| Part 3 (Bioavailability): Area under plasma concentration-time curve from zero to infinity [AUCinf] | Evaluating the relative oral bioavailability between the test formulation and the reference formulation after a single oral dose of AZD6793 in healthy subjects. | Day 1 to Day 3 | 
| Part 3 (Food effect): Cmax of AZD6793 | Investigating the effect of a high fat high calorie (HFHC) meal compared to fasting conditions, on the PK of AZD6793 after a single oral dose in healthy subjects. | Day 1 to Day 3 | 
| Part 3 (Food effect): AUCinf of AZD6793 | Investigating the effect of a high fat high calorie (HFHC) meal compared to fasting conditions, on the PK of AZD6793 after a single oral dose in healthy subjects. | Day 1 to Day 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Part 1 (SAD): Partial area under the plasma concentration time curve from time 0 to time 12 (AUC(0-12)) | Characterizing pharmacokinetics of AZD6793 following oral administration of SAD in healthy subjects. | Day 1 to Day 3 | 
| Part 1 (SAD): Partial area under the plasma concentration time curve from time 0 to time 24 (AUC(0-24)) | Characterizing pharmacokinetics of AZD6793 following oral administration of SAD in healthy subjects. | Day 1 to Day 3 | 
| Part 2 (MAD): Partial area under the plasma concentration time curve from time 0 to time 24 (AUC(0-24)) | Characterizing pharmacokinetics of AZD6793 following oral administration of MAD in healthy subjects. | Day 1 to Day 10 | 
| Part 2 (MAD): Area under plasma concentration time curve in the dosing interval t (AUCt) | Characterizing pharmacokinetics of AZD6793 following oral administration of MAD in healthy subjects. | Day 1 to Day 10 | 
| Part 1 (SAD): Area under the plasma concentration time curve from time zero extrapolated to infinity divided by the dose administered (Dose normalised AUCinf) | Characterizing pharmacokinetics of AZD6793 following oral administration of SAD in healthy subjects. | Day 1 to Day 3 | 
| Part 2 (MAD): Area under the plasma concentration-time curve from time zero to the dosing interval t concentration divided by the dose administered (Dose normalised AUCt) | Characterizing pharmacokinetics of AZD6793 following oral administration of MAD in healthy subjects. | Day 1 to Day 10 | 
| Part 1 (SAD): Area under the plasma concentration time curve from time zero to time of last quantifiable analyte concentration divided by the dose administered (Dose normalised AUClast) | Characterizing pharmacokinetics of AZD6793 following oral administration of SAD in healthy subjects. | Day 1 to Day 3 | 
| Part 2 (MAD): Area under the plasma concentration time curve from time zero to time of last quantifiable analyte concentration divided by the dose administered (Dose normalised AUClast) | Characterizing pharmacokinetics of AZD6793 following oral administration of MAD in healthy subjects. | Day 1 to Day 10 | 
| Part 1 (SAD): Maximum observed plasma (peak) drug concentration (Cmax) | Characterizing pharmacokinetics of AZD6793 following oral administration of SAD in healthy subjects. | Day 1 to Day 3 | 
| Part 2 (MAD): Maximum observed plasma (peak) drug concentration (Cmax) | Characterizing pharmacokinetics of AZD6793 following oral administration of MAD in healthy subjects. | Day 1 to Day 10 | 
| Part 1 (SAD): Time to reach peak or maximum observed concentration or response following drug administration (tmax) | Characterizing pharmacokinetics of AZD6793 following oral administration of SAD in healthy subjects. | Day 1 to Day 3 | 
| Part 2 (MAD): Time to reach peak or maximum observed concentration or response following drug administration (tmax) | Characterizing pharmacokinetics of AZD6793 following oral administration of MAD in healthy subjects. | Day 1 to Day 10 | 
| Part 1 (SAD): Terminal rate constant, estimated by log linear least squares regression of the terminal part of the concentration time curve (λz) | Characterizing pharmacokinetics of AZD6793 following oral administration of SAD in healthy subjects. | Day 1 to Day 3 | 
| Part 2 (MAD): Terminal rate constant, estimated by log linear least squares regression of the terminal part of the concentration time curve (λz) | Characterizing pharmacokinetics of AZD6793 following oral administration of MAD in healthy subjects. | Day 1 to Day 10 | 
| Part 1 (SAD): Half life associated with terminal slope (λz) of a semi logarithmic concentration time curve ( t½λz) | Characterizing pharmacokinetics of AZD6793 following oral administration of SAD in healthy subjects. | Day 1 to Day 3 | 
| Part 2 (MAD): Half life associated with terminal slope (λz) of a semi logarithmic concentration time curve ( t½λz) | Characterizing pharmacokinetics of AZD6793 following oral administration of MAD in healthy subjects. | Day 1 to Day 10 | 
| Part 1 (SAD): Area under plasma concentration time curve from zero to infinity (AUCinf) | Characterizing pharmacokinetics of AZD6793 following oral administration of SAD in healthy subjects. | Day 1 to Day 3 | 
| Part 2 (MAD): Area under plasma concentration time curve from zero to infinity (AUCinf) | Characterizing pharmacokinetics of AZD6793 following oral administration of MAD in healthy subjects. | Day 1 to Day 10 | 
| Part 1 (SAD): Area under the plasma concentration curve from zero to the last quantifiable concentration (AUClast) | Characterizing pharmacokinetics of AZD6793 following oral administration of SAD in healthy subjects. | Day 1 to Day 3 | 
| Part 2 (MAD): Area under the plasma concentration curve from zero to the last quantifiable concentration (AUClast) | Characterizing pharmacokinetics of AZD6793 following oral administration of MAD in healthy subjects. | Day 1 to Day 10 | 
| Part 1 (SAD): Apparent total body clearance of drug from plasma after extravascular administration (CL/F) | Characterizing pharmacokinetics of AZD6793 following oral administration of SAD in healthy subjects. | Day 1 to Day 3 | 
| Part 2 (MAD): Apparent total body clearance of drug from plasma after extravascular administration (CL/F) | Characterizing pharmacokinetics of AZD6793 following oral administration of MAD in healthy subjects. | Day 1 to Day 10 | 
| Part 1 (SAD): Volume of distribution (apparent) at steady state following extravascular administration (based on terminal phase) (Vz/F) | Characterizing pharmacokinetics of AZD6793 following oral administration of SAD in healthy subjects. | Day 1 to Day 3 | 
| Part 2 (MAD): Volume of distribution (apparent) at steady state following extravascular administration (based on terminal phase) (Vz/F) | Characterizing pharmacokinetics of AZD6793 following oral administration of MAD in healthy subjects. | Day 1 to Day 10 | 
| Part 1 (SAD): Maximum observed plasma (peak) drug concentration divided by the dose administered (Dose normalised Cmax). | Characterizing pharmacokinetics of AZD6793 following oral administration of SAD in healthy subjects. | Day 1 to Day 3 | 
| Part 2 (MAD): Maximum observed plasma (peak) drug concentration divided by the dose administered (Dose normalised Cmax) | Characterizing pharmacokinetics of AZD6793 following oral administration of MAD in healthy subjects. | Day 1 to Day 10 | 
| Part 2 (MAD): Concentration at the end of the dosing interval (Ctrough) | Characterizing pharmacokinetics of AZD6793 following oral administration of MAD in healthy subjects. | Day 1 to Day 10 | 
| Part 2 (MAD): Ratio of the area under the curve (Rac AUC) | Characterizing pharmacokinetics of AZD6793 following oral administration of MAD in healthy subjects. | Day 1 to Day 10 | 
| Part 2 (MAD): Accumulation ratio based on Cmax (Rac Cmax) | Characterizing pharmacokinetics of AZD6793 following oral administration of MAD in healthy subjects. | Day 1 to Day 10 | 
| Part 2 (MAD): Cumulative amount of unchanged drug excreted into urine from time t1 to time t2 [Ae(t1 t2)] | Characterizing pharmacokinetics of AZD6793 following oral administration of MAD in healthy subjects. | Day 1 and Day 8 | 
| Part 2 (MAD): Cumulative amount of unchanged drug excreted into urine (Aeinf) | Characterizing pharmacokinetics of AZD6793 following oral administration of MAD in healthy subjects. | Day 1 and Day 8 | 
| Part 2 (MAD): Renal clearance of drug from plasma (CLR) assessed in urine | Characterizing pharmacokinetics of AZD6793 following oral administration of MAD in healthy subjects. | Day 1 and Day 8 | 
| Part 2 (MAD): Temporal change parameter (TCP) assessed in urine | Characterizing pharmacokinetics of AZD6793 following oral administration of MAD in healthy subjects. | Day 1 and Day 8 | 
| Part 3 (Bioavailability): Cmax of AZD6793 (test Vs reference formulation) | To assess the PK profiles of AZD6793 when administered as a test formulation versus reference formulation in healthy subjects | Day 1 to Day 3 | 
| Part 3 (Bioavailability): tmax of AZD6793 (test Vs reference formulation) | To assess the PK profiles of AZD6793 when administered as a test formulation versus reference formulation in healthy subjects | Day 1 to Day 3 | 
| Part 3 (Bioavailability): λz of AZD6793 (test Vs reference formulation) | To assess the PK profiles of AZD6793 when administered as a test formulation versus reference formulation in healthy subjects | Day 1 to Day 3 | 
| Part 3 (Bioavailability): t½λz of AZD6793 (test Vs reference formulation) | To assess the PK profiles of AZD6793 when administered as a test formulation versus reference formulation in healthy subjects | Day 1 to Day 3 | 
| Part 3 (Bioavailability): AUC(0-12) of AZD6793 (test Vs reference formulation) | To assess the PK profiles of AZD6793 when administered as a test formulation versus reference formulation in healthy subjects | Day 1 to Day 3 | 
| Part 3 (Bioavailability): AUC(0-24) of AZD6793 (test Vs reference formulation) | To assess the PK profiles of AZD6793 when administered as a test formulation versus reference formulation in healthy subjects | Day 1 to Day 3 | 
| Part 3 (Bioavailability): AUClast of AZD6793 (test Vs reference formulation) | To assess the PK profiles of AZD6793 when administered as a test formulation versus reference formulation in healthy subjects | Day 1 to Day 3 | 
| Part 3 (Bioavailability): AUCinf of AZD6793 (test Vs reference formulation) | To assess the PK profiles of AZD6793 when administered as a test formulation versus reference formulation in healthy subjects | Day 1 to Day 3 | 
| Part 3 (Bioavailability): CL/F of AZD6793 (test Vs reference formulation) | To assess the PK profiles of AZD6793 when administered as a test formulation versus reference formulation in healthy subjects | Day 1 to Day 3 | 
| Part 3 (Bioavailability): Vz/F of AZD6793 (test Vs reference formulation) | To assess the PK profiles of AZD6793 when administered as a test formulation versus reference formulation in healthy subjects | Day 1 to Day 3 | 
| Part 3 (Bioavailability) :Relative bioavailability calculated as test AUC/reference AUC [Frel AUC] | To assess the PK profiles of AZD6793 when administered as a test formulation versus reference formulation in healthy subjects | Day 1 to Day 3 | 
| Part 3 (Bioavailability): Relative bioavailability calculated as test Cmax/reference Cmax [Frel Cmax] | To assess the PK profiles of AZD6793 when administered as a test formulation versus reference formulation in healthy subjects | Day 1 to Day 3 | 
| Part 3 (Food effect): Cmax of AZD6793 (under fasted and fed state) | To examine the PK profiles of AZD6793 (film-coated tablet only) under fasted and fed (after intake of a HFHC meal) conditions in healthy subjects. | Day 1 to Day 3 | 
| Part 3 (Food effect): tmax of AZD6793 (under fasted and fed state) | To examine the PK profiles of AZD6793 (film-coated tablet only) under fasted and fed (after intake of a HFHC meal) conditions in healthy subjects. | Day 1 to Day 3 | 
| Part 3 (Food effect): λz of AZD6793 (under fasted and fed state) | To examine the PK profiles of AZD6793 (film-coated tablet only) under fasted and fed (after intake of a HFHC meal) conditions in healthy subjects. | Day 1 to Day 3 | 
| Part 3 (Food effect): t½λz of AZD6793 (under fasted and fed state) | To examine the PK profiles of AZD6793 (film-coated tablet only) under fasted and fed (after intake of a HFHC meal) conditions in healthy subjects. | Day 1 to Day 3 | 
| Part 3 (Food effect): AUC(0-12) of AZD6793 (under fasted and fed state) | To examine the PK profiles of AZD6793 (film-coated tablet only) under fasted and fed (after intake of a HFHC meal) conditions in healthy subjects. | Day 1 to Day 3 | 
| Part 3 (Food effect): AUC(0-24) of AZD6793 (under fasted and fed state) | To examine the PK profiles of AZD6793 (film-coated tablet only) under fasted and fed (after intake of a HFHC meal) conditions in healthy subjects. | Day 1 to Day 3 | 
| Part 3 (Food effect): AUClast of AZD6793 (under fasted and fed state) | To examine the PK profiles of AZD6793 (film-coated tablet only) under fasted and fed (after intake of a HFHC meal) conditions in healthy subjects. | Day 1 to Day 3 | 
| Part 3 (Food effect): AUCinf of AZD6793 (under fasted and fed state) | To examine the PK profiles of AZD6793 (film-coated tablet only) under fasted and fed (after intake of a HFHC meal) conditions in healthy subjects. | Day 1 to Day 3 | 
| Part 3 (Food effect): CL/F of AZD6793 (under fasted and fed state) | To examine the PK profiles of AZD6793 (film-coated tablet only) under fasted and fed (after intake of a HFHC meal) conditions in healthy subjects. | Day 1 to Day 3 | 
| Part 3 (Food effect): Vz/F of AZD6793 (under fasted and fed state) | To examine the PK profiles of AZD6793 (film-coated tablet only) under fasted and fed (after intake of a HFHC meal) conditions in healthy subjects. | Day 1 to Day 3 | 
| Part 3 (Food effect) :Frel AUC of AZD6793 (under fasted and fed state) | To examine the PK profiles of AZD6793 (film-coated tablet only) under fasted and fed (after intake of a HFHC meal) conditions in healthy subjects. | Day 1 to Day 3 | 
| Part 3 (Food effect): Frel Cmax of AZD6793 (under fasted and fed state) | To examine the PK profiles of AZD6793 (film-coated tablet only) under fasted and fed (after intake of a HFHC meal) conditions in healthy subjects. | Day 1 to Day 3 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IRAK4 kinase inhibitor, AZD6793