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A Drug Interaction Study of Simvastatin and Albiglutide

Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Diabetes Mellitus, Type 2; Healthy

Intervention: simvastatin plus albiglutide (Biological)

Phase: Phase 1

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline

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.

Clinical Details

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

Study design: Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Primary outcome: The effect of albiglutide on the pharmacokinetics of simvastatin

Secondary outcome: The pertinent plasma pharmacokinetic parameters of simvastatin with and without albiglutide

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.

Eligibility

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.

Criteria:

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 and Contacts

GSK Investigational Site, Austin, Texas 78744, United States
Additional Information

Starting date: May 2010
Last updated: January 22, 2011

Page last updated: August 23, 2015

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