A Drug Interaction Study of Albiglutide and Digoxin

GlaxoSmithKline30 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Diabetes Mellitus, Type 2

Interventions

digoxin plus albiglutideBIOLOGICAL

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (1)

GSK Investigational Site

Austin, Texas, United States

Outcomes

Primary Outcomes

The pharmacokinetic parameters of digoxin with and without albiglutide

Time frame: 38 days

Secondary Outcomes

Safety of digoxin with and without albiglutide

Time frame: 38 days

Data from ClinicalTrials.gov

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