A Drug Interaction Study With Albiglutide and Warfarin

GlaxoSmithKline16 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Diabetes Mellitus, Type 2

Interventions

warfarin plus albiglutideBIOLOGICAL

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.

Eligibility

Sex: MALEMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (1)

GSK Investigational Site

Austin, Texas, United States

Outcomes

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

Data from ClinicalTrials.gov

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