A Drug Interaction Study of Albiglutide and Digoxin

Phase 1

Completed

• Conditions: Diabetes Mellitus, Type 2

• Registration Number: NCT01147718
• Lead Sponsor: GlaxoSmithKline

Brief Summary

This Phase I, open-label, sequential, single-center study evaluates the pharmacokinetics of digoxin when coadministered with albiglutide in healthy adult subjects.

Detailed Description

This Phase I, open-label, sequential, single-center study evaluates the pharmacokinetics of digoxin when coadministered with albiglutide in healthy adult subjects. Subjects will receive a single dose of digoxin on Day 1 followed by 5 weekly subcutaneously injected doses of albiglutide and a second single dose of digoxin on Day 38. To determine the plasma pharmacokinetic parameters of digoxin after drug administration alone and after multiple doses of albiglutide, blood samples will be collected after each dose of digoxin.

Study Timeline

• Study First Submitted: 2010-04-29
• Study Start: 2010-06-11
• Study First Submitted QC: 2010-06-17
• Study First Posted: 2010-06-22
• Primary Completion: 2010-11-29
• Study Completion: 2010-11-29
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-09
• Last Update Posted: 2017-06-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• healthy volunteers
• female subjects must be of nonchildbearing potential
• no clinically significant diseases or clinically significant abnormal laboratory values
• body mass index (BMI) is >/=18 kg and ≤30 kg/m2
• a nonsmoker

Exclusion Criteria

• positive test results for hepatitis B, hepatitis C or human immunodeficiency virus
• female subject is pregnant or breast-feeding
• history of any anaphylactic reaction to any drug
• history of significant cardiovascular or pulmonary dysfunction
• 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
• history of cholecystitis or other gallbladder disease
• previously received any GLP-1 mimetic compound (e.g., exenatide)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
The pharmacokinetic parameters of digoxin with and without albiglutide	38 days

Secondary Outcome Measures

Name	Time	Method
Safety of digoxin with and without albiglutide	38 days

Trial Locations

Locations (1)

GSK Investigational Site; 🇺🇸 Austin, Texas, United States