A Drug Interaction Study With Albiglutide and Warfarin

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01147731
• Other study ID #: 111681
• Status: Completed
• Phase: Phase 1
• First received: April 29, 2010
• Last updated: June 21, 2017
• Start date: June 4, 2010
• Est. completion date: September 9, 2010

Study information

• Verified date: June 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: September 9, 2010
• Est. primary completion date: September 9, 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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)

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

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.

Locations

Country	Name	City	State
United States	GSK Investigational Site	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

References & Publications (1)

Bush M, Scott R, Watanalumlerd P, Zhi H, Lewis E. Effects of multiple doses of albiglutide on the pharmacokinetics, pharmacodynamics, and safety of digoxin, warfarin, or a low-dose oral contraceptive. Postgrad Med. 2012 Nov;124(6):55-72. doi: 10.3810/pgm.2012.11.2613. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The pharmacokinetic parameters (AUC and Cmax) of R and S-warfarin isomers with and without albiglutide		52 days
Secondary	The effect of albiglutide on the pharmacodynamics of warfarin as determined by the International Normalisation Ratio (INR).		52 days

External Links

•   Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
•   Results for study 111681 can be found on the GSK Clinical Study Register.