A Drug Interaction Study With Albiglutide and Warfarin

Phase 1

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Biological: warfarin plus albiglutide

• Registration Number: NCT01147731
• Lead Sponsor: GlaxoSmithKline

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2010-04-29
• Study Start: 2010-06-04
• Study First Submitted QC: 2010-06-17
• Study First Posted: 2010-06-22
• Primary Completion: 2010-09-09
• Study Completion: 2010-09-09
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-21
• Last Update Posted: 2017-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 16

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
warfarin plus albiglutide	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.

Primary Outcome Measures

Name	Time	Method
The pharmacokinetic parameters (AUC and Cmax) of R and S-warfarin isomers with and without albiglutide	52 days

Secondary Outcome Measures

Name	Time	Method
The effect of albiglutide on the pharmacodynamics of warfarin as determined by the International Normalisation Ratio (INR).	52 days

Trial Locations

Locations (1)

GSK Investigational Site; 🇺🇸 Austin, Texas, United States