A Drug Interaction Study With Albiglutide and Warfarin

NCT01147731 | Completed Phase 1

• 1 other identifier: 111681
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2

Keywords

pharmacokinetics; albiglutide; warfarin; Healthy volunteers

Outcome Measures

Primary Outcomes (1)

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

  52 days

Secondary Outcomes (1)

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

  52 days

Study Arms (1)

warfarin plus albiglutide

EXPERIMENTAL

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

Interventions

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.

warfarin plus albiglutide

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Austin, Texas, 78744, United States

Location

Related Publications (2)

• 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.

  PMID: 23322139 BACKGROUND

• Young MA, Wald JA, Matthews JE, Scott R, Hodge RJ, Zhi H, Reinhardt RR. Clinical pharmacology of albiglutide, a GLP-1 receptor agonist. Postgrad Med. 2014 Nov;126(7):84-97. doi: 10.3810/pgm.2014.11.2836.

  PMID: 25387217 DERIVED

Related 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.

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Warfarin; rGLP-1 protein

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2010
• First Posted: June 22, 2010
• Study Start: June 4, 2010
• Primary Completion: September 9, 2010
• Study Completion: September 9, 2010
• Last Updated: June 22, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will share

Locations

US (1)