AZD5672 Bioavailability Study in Healthy Male and Female Subjects

Study Overview
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Brief Summary
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The aim of this study is to compare the blood levels achieved with a new formulation of AZD5672 to an existing formulation of AZD5672 used in previous studies

Official Title
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An Open-Label, Randomized, 4 Period Crossover, Replicate Study to Assess the Relative Bioavailability of the Phase III and Phase IIb Formulations of AZD5672 in Healthy Male and Female Subjects

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Drug: AZD5672
* Drug: AZD5672
* Drug: AZD5672
* Drug: AZD5672


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provision of informed consent prior to any study-specific procedures BMI between 18 and 30 kg/m2 Medical and surgical history and physical examination without any clinically significant findings Non smokers or past smokers who have stopped smoking within the last 6 months. Exclusion Criteria: History of clinically significant cardio- or cerebrovascular, pulmonary, renal, hepatic, neurological, mental or gastrointestinal disorder or any other major disorder that may interfere with the objectives of the study, as judged by the Investigator Clinically significant illness as judged by the Investigator, within two weeks before the first administration of investigational product. Female subjects who have a positive pregnancy test or who are pregnant or breast-feeding

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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>40 or 100mg AZD5672, Reference formulation | Drug: AZD5672<br>* 40 mg tablet (Reference formulation)<br>Drug: AZD5672<br>* 100 mg (2 x 50 mg tablet (Reference Formulation)<br>|
| Experimental: 2<br>40 or 100mg AZD5672, Test formulation | Drug: AZD5672<br>* 40 mg tablet (Test formulation)<br>Drug: AZD5672<br>* 100 mg tablet (Test formulation)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relative bioavailability of AZD5672 using PK variables AUC ss and C max ss |  | Frequent sampling occasions during study periods, with intensive sampling occurring on days 7,14,21 and 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety variables (adverse events, blood pressure, pulse, safety lab) |  | AE assessed throughout whole the study, twice weekly assessment of BP, pulse and safety labs throughout study period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AZD5672, relative bioavailability, rheumatoid arthritis (RA)