AZD5672 Absolute Bioavailability Study
Phase 1
Completed
- Conditions
- Healthy Volunteers
- Interventions
- Drug: AZD5672
- Registration Number
- NCT00746837
- Lead Sponsor
- AstraZeneca
- Brief Summary
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)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 26
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
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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).
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 AZD5672 Single ascending IV dose, 3 treatment periods separated by a minimum 14 day washout between doses 2 AZD5672 2 cohorts single IV dose + multiple oral dose period separated by a minimum of 14 days washout between IV and oral dose
- Primary Outcome Measures
Name Time Method PK variables Frequent sampling occasions during study periods
- Secondary Outcome Measures
Name Time Method Safety variables (adverse events, blood pressure, pulse, safety lab) During the whole treatment periods
Trial Locations
- Locations (1)
Research Site
🇬🇧Harrow, London, United Kingdom