A Drug Interaction Study of Simvastatin and Albiglutide

Phase 1

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Biological: simvastatin plus albiglutide

• Registration Number: NCT01147692
• Lead Sponsor: GlaxoSmithKline

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2010-04-29
• Study Start: 2010-05-19
• Study First Submitted QC: 2010-06-17
• Study First Posted: 2010-06-22
• Primary Completion: 2010-08-27
• Study Completion: 2010-08-27
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-07
• Last Update Posted: 2017-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
simvastatin plus albiglutide	simvastatin plus albiglutide	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.

Primary Outcome Measures

Name	Time	Method
The effect of albiglutide on the pharmacokinetics of simvastatin	42 days

Secondary Outcome Measures

Name	Time	Method
The pertinent plasma pharmacokinetic parameters of simvastatin with and without albiglutide	42 days

Trial Locations

Locations (1)

GSK Investigational Site; 🇺🇸 Austin, Texas, United States