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A Drug Interaction Study With Albiglutide and Warfarin

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01147731
First received: April 29, 2010
Last updated: January 22, 2011
Last verified: November 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Healthy
 Biological: warfarin plus albiglutide
 Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: An Open-label, Sequential Study to Evaluate the Pharmacokinetics of Warfarin When Coadministered With Albiglutide in Healthy Adult Subjects

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • The pharmacokinetic parameters (AUC and Cmax) of R and S-warfarin isomers with and without albiglutide [ Time Frame: 52 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The effect of albiglutide on the pharmacodynamics of warfarin as determined by the International Normalisation Ratio (INR). [ Time Frame: 52 days ] [ Designated as safety issue: No ]

Enrollment: 16
Study Start Date: June 2010
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
 Biological: 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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01147731

Locations
United States, Texas
GSK Investigational Site
Austin, Texas, United States, 78744
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: E.D. Derilus; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT01147731     History of Changes
Other Study ID Numbers: 111681
Study First Received: April 29, 2010
Last Updated: January 22, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
pharmacokinetics
albiglutide
warfarin
Healthy volunteers

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Warfarin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013