AZD5672 Absolute Bioavailability Study
A Phase I Study to Assess Absolute Bioavailability of AZD5672 at Steady-state in Healthy Volunteers
2 other identifiers
interventional
26
1 country
1
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 healthy-volunteers
Started Aug 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2008
CompletedFirst Submitted
Initial submission to the registry
September 3, 2008
CompletedFirst Posted
Study publicly available on registry
September 4, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2009
CompletedDecember 2, 2010
November 1, 2010
5 months
September 3, 2008
November 30, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
PK variables
Frequent sampling occasions during study periods
Secondary Outcomes (1)
Safety variables (adverse events, blood pressure, pulse, safety lab)
During the whole treatment periods
Study Arms (2)
1
EXPERIMENTALSingle ascending IV dose, 3 treatment periods separated by a minimum 14 day washout between doses
2
EXPERIMENTAL2 cohorts single IV dose + multiple oral dose period separated by a minimum of 14 days washout between IV and oral dose
Interventions
single IV doses starting at 7 mg, subsequent doses to be confirmed following review of PK and safety data after each treatment period
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (1)
Research Site
Harrow, London, United Kingdom
MeSH Terms
Interventions
Study Officials
- STUDY DIRECTOR
Mark Layton, MD, PhD
AstraZeneca R&D, Charnwood, UK
- PRINCIPAL INVESTIGATOR
Tania Hugo
PAREXEL Clinical Pharmacology Research Unit
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 3, 2008
First Posted
September 4, 2008
Study Start
August 1, 2008
Primary Completion
January 1, 2009
Study Completion
January 1, 2009
Last Updated
December 2, 2010
Record last verified: 2010-11