A Drug Interaction Study of Simvastatin and Albiglutide

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 1

Conditions: Diabetes Mellitus, Type 2

Treatments: Biological: simvastatin plus albiglutide

Study type: Interventional

Funder types: Industry

Identifiers

NCT01147692

108366

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

simvastatin plus albiglutide

Experimental group

Description:

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.

Treatment:

Biological: simvastatin plus albiglutide