A Drug Interaction Study With Albiglutide and Warfarin

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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An Open-label, Sequential Study to Evaluate the Pharmacokinetics of Warfarin When Coadministered With Albiglutide in Healthy Adult Subjects

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Biological: warfarin plus albiglutide


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: warfarin plus albiglutide<br>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. | Biological: warfarin plus albiglutide<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The pharmacokinetic parameters (AUC and Cmax) of R and S-warfarin isomers with and without albiglutide |  | 52 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effect of albiglutide on the pharmacodynamics of warfarin as determined by the International Normalisation Ratio (INR). |  | 52 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pharmacokinetics, albiglutide, warfarin, Healthy volunteers