AZD6765 Oral Single Ascending Dose/Multiple Ascending Dose (SAD/MAD)

Study Overview
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Brief Summary
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The purpose of this study is to determine the safety of AZD6765 when given in single and multiple oral doses and to compare an oral and intravenous (IV) formulation of AZD6765 to placebo.

Official Title
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Pt. A: Ph I, Sngl-Blind, Randomized, Pcbo-Controlled 3-Way Crossover Study Followed by an Open-label Food Effect Study to Assess the PK of IV and Oral AZD6765 in Healthy Male and Female Subjects Pt.B: Ph I, Double-Blind, Randomized, Placebo-Controlled Study to Assess the Safety, Tolerability and PK of AZD6765 When Administered in Multiple Ascending Doses to Healthy Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: AZD6765
* Drug: AZD6765


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy volunteers Females must be of non-childbearing potential. Exclusion Criteria: Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of investigational product. Has received another new chemical entity (defined as a compound which has not been approved for marketing) or has participated in any other clinical study that included drug treatment within 3 months (if half-life was < 24 hours) of the first administration of study drug Plasma or blood product donation within one month of screening or any blood donation/blood loss > 500mL during the 3 months prior to screening.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AZD6765 oral solution<br>Active | Drug: AZD6765<br>* Single oral dose and single IV infusion of AZD6765<br>Drug: AZD6765<br>* Once-daily oral dose of AZD6765 or placebo on Day 1 and on Days 4 through 9.<br>|
| Experimental: AZD6765 IV infusion<br>Active | Drug: AZD6765<br>* Single oral dose and single IV infusion of AZD6765<br>|
| Placebo Comparator: Placebo to AZD6765 oral solution<br>Placebo | Drug: AZD6765<br>* Single oral dose and single IV infusion of AZD6765<br>Drug: AZD6765<br>* Once-daily oral dose of AZD6765 or placebo on Day 1 and on Days 4 through 9.<br>|
| Placebo Comparator: Placebo to AZD6765 IV infusion<br>Placebo | Drug: AZD6765<br>* Single oral dose and single IV infusion of AZD6765<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The objective of the study is to investigate the safety and tolerability of AZD6765 when administered orally in single and multiple doses to healthy subjects by assessment of adverse events, vital signs, physical examinations, electrocardiograms(ECG). |  | Safety assessments are made prior to and after drug administration. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Part A 1. To characterize the single dose pharmacokinetics of AZD67652. To assess the absolute bioavailability of AZD67653. To assess the effect of food on the pharmacokinetics of AZD6765 |  | Blood samples will be obtained on Days 1-5. | 
| Part B 1. To characterize the single and multiple dose pharmacokinetics of AZD6765 2. To assess dose linearity and proportionality of AZD67653. To assess the degree of accumulation and the time dependence of the pharmacokinetics of AZD6765 |  | Blood samples will be obtained on Days 1-4 and 7-11. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Phase 1, Healthy volunteers