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NCT Number: NCT01147731

A Drug Interaction Study With Albiglutide and Warfarin

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

GSK Investigational Site

Austin, Texas, 78744, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

warfarin plus albiglutide

Biological

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 outcomes

  1. The pharmacokinetic parameters (AUC and Cmax) of R and S-warfarin isomers with and without albiglutide

    Time frame: 52 days

Secondary outcomes

  1. The effect of albiglutide on the pharmacodynamics of warfarin as determined by the International Normalisation Ratio (INR).

    Time frame: 52 days

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Jun 22, 2010
Registry last updated
Jun 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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