A Drug Interaction Study of Albiglutide and Digoxin

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 1

Conditions: Diabetes Mellitus, Type 2

Treatments: Biological: digoxin plus albiglutide

Study type: Interventional

Funder types: Industry

Identifiers

NCT01147718

111680

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

digoxin plus albiglutide

Experimental group

Description:

A single dose of 0.5mg digoxin administered on Day 1 followed by 5 weekly subcutaneous injections of albiglutide, followed by a further single dose of 0.5mg digoxin on Day 38.

Treatment:

Biological: digoxin plus albiglutide