A Drug Interaction Study With Albiglutide and Warfarin

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01147731

Enrollment

Registered

2010-06-22

Start date

2010-06-04

Completion date

2010-09-09

Last updated

2017-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2

Keywords

pharmacokinetics, albiglutide, warfarin, Healthy volunteers

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.

Interventions

BIOLOGICALwarfarin 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.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 55 Years

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)

Design outcomes

Primary

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

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 19, 2026