Last updated: 11/07/2018 03:44:50
A drug interaction study with albiglutide and warfarin
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: An Open-label, Sequential Study to Evaluate the Pharmacokinetics of Warfarin When Coadministered With Albiglutide in Healthy Adult Subjects
Trial description: 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.
Primary purpose:
Basic Science
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
The pharmacokinetic parameters (AUC and Cmax) of R and S-warfarin isomers with and without albiglutide
Timeframe: 52 days
Secondary outcomes:
The effect of albiglutide on the pharmacodynamics of warfarin as determined by the International Normalisation Ratio (INR).
Timeframe: 52 days
Interventions:
Biological/vaccine: warfarin plus albiglutide
Enrollment:
16
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Mark Bush, Rhona Scott, Prapoch Watanalumlerd, Hui Zhi & Eric Lewis. The effects of multiple doses of Albiglutide on the pharmacokinetics pharmacodynamics and safety of digoxin, warfarin or a low-dose oral contraceptive. Postgrad Med. 2012;124(6):1-18.
Mark Bush, Rhona Scott, Prapoch Watanalumlerd, Hui Zhi & Eric Lewis. The effects of multiple doses of Albiglutide on the pharmacokinetics pharmacodynamics and safety of digoxin, warfarin or a low-dose oral contraceptive. Postgrad Med. 2012;124(6):55-72.
Medical condition
Diabetes Mellitus, Type 2
Product
albiglutide
Collaborators
Not applicable
Study date(s)
June 2010 to September 2010
Type
Interventional
Phase
1
Participation criteria
Sex
Male
Age
18 - 55 years
Accepts healthy volunteers
Yes
- male healthy volunteers in good health
- no clinically significant diseases or clinically significant abnormal laboratory values
- positive test results for hepatitis B, hepatitis C or human immunodeficiency virus (HIV)
- any clinically relevant abnormality
Inclusion and exclusion criteria
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)
Trial location(s)
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2010-09-09
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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Additional information
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