A Drug Interaction Study of Simvastatin and Albiglutide

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

An Open-label, Sequential Study to Evaluate the Pharmacokinetics of Simvastatin When Coadministered With Albiglutide in Healthy Adult Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01147692
• Other study ID #: 108366
• Status: Completed
• Phase: Phase 1
• First received: April 29, 2010
• Last updated: June 7, 2017
• Start date: May 19, 2010
• Est. completion date: August 27, 2010

Study information

• Verified date: June 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 27, 2010
• Est. primary completion date: August 27, 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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)

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Biological:
• 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.

Locations

Country	Name	City	State
United States	GSK Investigational Site	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The effect of albiglutide on the pharmacokinetics of simvastatin		42 days
Secondary	The pertinent plasma pharmacokinetic parameters of simvastatin with and without albiglutide		42 days

External Links

•   Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
•   Results for study 108366 can be found on the GSK Clinical Study Register.