BIOLOGICAL
warfarin plus albiglutide
A single dose of 25mg warfarin on day 1 followed by 5 weekly doses of subcutaneous albiglutide followed by a single dose of 25mg warfarin on day 45.
A Drug Interaction Study With Albiglutide and Warfarin
Status
Completed
Phase
Phase 1
Enrollment
16
Locations
1
Results
Not posted
Publications
2
Study summary
What the protocol is testing.
This open-label study evaluates the pharmacokinetics of warfarin when coadministered with albiglutide in healthy adult subjects. The primary objective is to assess the effect of albiglutide doses on the pharmacokinetics of warfarin.
Full detailed description
This Phase I open-label study evaluates the pharmacokinetics of warfarin when coadministered with albiglutide in healthy adult subjects. The primary objective is to assess the effect of albiglutide doses on the pharmacokinetics of warfarin.
Interventions
Treatment arms and agents.
Timeline
From registration to results.
First posted
Jun 22, 2010
Study start
Jun 4, 2010
Primary completion
Sep 9, 2010
Study completion
Sep 9, 2010
Results posted
Not reported
Registry updated
Jun 22, 2017
Outcomes
What the study measures.
Primary outcomes
The pharmacokinetic parameters (AUC and Cmax) of R and S-warfarin isomers with and without albiglutide
Time frame · 52 days
Secondary outcomes
The effect of albiglutide on the pharmacodynamics of warfarin as determined by the International Normalisation Ratio (INR).
Time frame · 52 days
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- 55 Years
- Sex
- MALE
- Healthy volunteers
- Yes
Inclusion Criteria: * male healthy volunteers in good health * no clinically significant diseases or clinically significant abnormal laboratory values * body mass index (BMI) is \>/=18 kg and ≤30 kg/m2 * nonsmoker Exclusion Criteria: * positive test results for hepatitis B, hepatitis C or human immunodeficiency virus (HIV) * any clinically relevant abnormality * history of any anaphylactic reaction to any drug * history of significant cardiovascular or pulmonary dysfunction * history of excessive bleeding * current or chronic history of liver disease * history of alcohol or substance abuse * history of thyroid disease or dysfunction * history of gastrointestinal surgery or disease * history of pancreatitis * previously received any GLP-1 mimetic compound (e.g., exenatide)
Study locations
1 registered sites.
United States. Showing up to 24 locations stored in the fast local snapshot.
GSK Investigational Site
Austin, Texas, United States
Publications
Results and literature.
PMID 23322139 ↗Bush M, Scott R, Watanalumlerd P, Zhi H, Lewis E. Effects of multiple doses of albiglutide on the pharmacokinetics, pharmacodynamics, and safety of digoxin, warfarin, or a low-dose oral contraceptive. Postgrad Med. 2012 Nov;124(6):55-72. doi: 10.3810/pgm.2012.11.2613.PMID 25387217 ↗Young MA, Wald JA, Matthews JE, Scott R, Hodge RJ, Zhi H, Reinhardt RR. Clinical pharmacology of albiglutide, a GLP-1 receptor agonist. Postgrad Med. 2014 Nov;126(7):84-97. doi: 10.3810/pgm.2014.11.2836.
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Put the record in context.
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