AZD9668 Relative Bioavailability

Study Overview
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Brief Summary
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The study is designed to investigate the pharmacokinetic behaviour of the free base formulation of AZD9668. The study will compared the relative bioavailability of the free base formulation at two different dose levels compared to the tosylate salt formulation.

Official Title
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A Phase I Open-label, Single-centre, Two Cohort Crossover Study to Assess the Relative Bioavailability After Oral Administration of AZD9668 Free Base Dosed as a Suspension Compared to AZD9669 Tosylate Salt Dosed as a Tablet

Conditions
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Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* 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). 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 History of cardiac arrhythmia

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>tosylate salt tablet | Drug: AZD9668<br>* 20 mg<br>|
| Experimental: 2<br>free suspension | Drug: AZD9668<br>* 20 mg<br>|
| Experimental: 3<br>tosylate salt tablet | Drug: AZD9668<br>* 60 mg<br>|
| Experimental: 4<br>free suspension | Drug: AZD9668<br>* 60 mg<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 the free base of AZD9668 dosed as a suspension compared to the tosylate salt of AZD9668 dosed as a tablet formulation at two dose levels. |  | Frequent sampling occasions during the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety variables (adverse events, blood pressure, pulse rate, 12-lead ECG, haematology, clinical chemistry and urinalysis) |  | 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