AZD9668 Relative Bioavailability

Study Overview
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Brief Summary
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This clinical study will aid future formulation development and optimisation of AZD9668 tablets by evaluating possible effects of minor changes to the formulation and process on the rate and extent of absorption.

Official Title
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An Open-label, Single-centre, 3-way Single Dose Crossover Study to Assess the Relative Bioavailability After Oral Administration of a Tablet Variant of AZD9668 Compared to AZD9668 Tablets and to Further Investigate the Safety and Tolerability of AZD9668 in Healthy Subjects

Conditions
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Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Drug: AZD9668
* Drug: AZD9668
* Drug: AZD9668


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provision of informed consent prior to any study-specific procedures female subjects may be of non-child bearing potential (i.e. post menopausal or surgically sterile) or of child bearing potential Body mass index (BMI) ≥18.0 and ≤30.0 kg/m2 calculated from height and weight at the screening visit; minimum weight 50 kg. Clinically normal physical and laboratory findings as judged by the investigator, including negative test results for drug-of-abuse, alcohol, cotinine and negative test results for Hepatitis B surface antigen, antibodies to Hepatitis C virus and antibodies to HIV-1/2 at the screening visit Be a none smoker or ex-smoker who has stopped smoking for >6 months prior to visit 2 (pre-entry) Exclusion Criteria: Any clinically significant disease or disorder (eg infections/viral disease, cardiovascular, pulmonary, gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic, malignant, psychiatric, major physical impairment), which in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the absorption, distribution, metabolism and excretion of drugs. Any clinically relevant abnormal findings in physical examination, vital signs, clinical chemistry, haematology, urinalysis, which, in the opinion of the investigator, may put the subject at risk because of his/her participation in the study Any ECG abnormality (including cardiac arrhythmia) which in the opinion of the investigator may put the subject at risk

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

Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>AZD9668 2X30mg tablet | Drug: AZD9668<br>* 2 x 30 mg batch DLE494<br>Drug: AZD9668<br>* 2 x 30 mg batch DLF497<br>Drug: AZD9668<br>* 2 x 30 mg tablet variant 1<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relative bioavailability (Frel): to assess the relative systemic bioavailability after oral administration of a tablet variant of AZD9668 compared to AZD9668 tablets. |  | Frequent sampling occasions during the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety variables (adverse events, vital signs, haematology, clinical chemistry, urinalysis and 12-lead ECG) |  | Frequent sampling occasions during the study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD