AZD5672 Absolute Bioavailability Study

Study Overview
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Brief Summary
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The purpose of the study is to estimate the absolute bioavailability at steady state of 2 doses of AZD5672 (50 mg and 150 mg administered orally once daily)

Official Title
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A Phase I Study to Assess Absolute Bioavailability of AZD5672 at Steady-state in Healthy Volunteers

Conditions
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Healthy Volunteers

Intervention / Treatment
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* 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. Females should not be of childbearing potential Clinically normal physical and laboratory findings as judged by the investigator, including negative test results for drug-of-abuse, alcohol and cotinine at the Screening Visit and/or admission (Day -1) of each study period, and negative test results Exclusion Criteria: Any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or may influence the results of the study, or the subject's ability to participate Unsuitable venous access for intravenous studies Participation in a clinical study involving an investigational product within 5 half-lives of active moieties of the last dose of investigational product or 3 months prior to first dosing (whichever is longer).

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: Basic Science
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Single ascending IV dose, 3 treatment periods separated by a minimum 14 day washout between doses | Drug: AZD5672<br>* single IV doses starting at 7 mg, subsequent doses to be confirmed following review of PK and safety data after each treatment period<br>|
| Experimental: 2<br>2 cohorts single IV dose + multiple oral dose period separated by a minimum of 14 days washout between IV and oral dose | Drug: AZD5672<br>* single IV doses starting at 7 mg, subsequent doses to be confirmed following review of PK and safety data after each treatment period<br>Drug: AZD5672<br>* 50 mg od, 12 days<br>Drug: AZD5672<br>* 150mg od, 12 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK variables |  | Frequent sampling occasions during study periods | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety variables (adverse events, blood pressure, pulse, safety lab) |  | During the whole treatment periods | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AZD5672