A Drug Interaction Study of Simvastatin and Albiglutide

GlaxoSmithKline40 enrolled

Overview

This open-label study evaluates the pharmacokinetics of simvastatin when coadministered with albiglutide in healthy adult subjects. The primary objective is to assess the effect of albiglutide doses on the pharmacokinetics of simvastatin.

This Phase I open-label study evaluates the pharmacokinetics of simvastatin when coadministered with albiglutide in healthy adult subjects. The primary objective is to assess the effect of albiglutide doses on the pharmacokinetics of simvastatin.

Study Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Diabetes Mellitus, Type 2

Interventions

simvastatin plus albiglutideBIOLOGICAL

A single dose of 80mg simvastatin on Day 1 followed by 5 weekly doses of subcutaneous albiglutide followed by a single dose of 80mg simvastatin on Day 38.

Eligibility

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

Medical Language ↔ Plain English

Inclusion Criteria: * no clinically significant diseases or clinically significant abnormal laboratory values * females must be of non-childbearing potential * body mass index (BMI) is \>/=18 kg and ≤30 kg/m2 * nonsmoker * negative drug screen Exclusion Criteria: * positive test results for hepatitis B, hepatitis C or human immunodeficiency virus (HIV) * any clinically relevant abnormality * 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 dysfunction or disease * history of gastrointestinal surgery or disease * history of pancreatitis * previously received any GLP-1 mimetic compound (e.g., exenatide)

Locations (1)

GSK Investigational Site

Austin, Texas, United States

Outcomes

Primary Outcomes

The effect of albiglutide on the pharmacokinetics of simvastatin

Time frame: 42 days

Secondary Outcomes

The pertinent plasma pharmacokinetic parameters of simvastatin with and without albiglutide

Time frame: 42 days

Data from ClinicalTrials.gov

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