A Drug Interaction Study of Albiglutide and Digoxin

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01147718
• Other study ID #: 111680
• Status: Completed
• Phase: Phase 1
• First received: April 29, 2010
• Last updated: June 9, 2017
• Start date: June 11, 2010
• Est. completion date: November 29, 2010

Study information

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

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 29, 2010
• Est. primary completion date: November 29, 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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)

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Biological:
• digoxin plus albiglutide
A single dose of 0.5mg digoxin on Day 1 followed by 5 weekly doses of subcutaneous albiglutide, followed by a single dose of 0.5mg digoxin on Day 38.

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 of digoxin with and without albiglutide		38 days
Secondary	Safety of digoxin with and without albiglutide		38 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 111680 can be found on the GSK Clinical Study Register.