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A Drug Interaction Study With Albiglutide and Warfarin

Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Diabetes Mellitus, Type 2; Healthy

Intervention: warfarin plus albiglutide (Biological)

Phase: Phase 1

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline

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.

Clinical Details

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

Study design: Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

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

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

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

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Male.

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)

Locations and Contacts

GSK Investigational Site, Austin, Texas 78744, United States
Additional Information

Starting date: June 2010
Last updated: January 22, 2011

Page last updated: August 23, 2015

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