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.
A Drug Interaction Study of Simvastatin and Albiglutide
Status
Completed
Phase
Phase 1
Enrollment
40
Locations
1
Results
Not posted
Publications
1
Study summary
What the protocol is testing.
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 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.
Interventions
Treatment arms and agents.
Timeline
From registration to results.
First posted
Jun 22, 2010
Study start
May 19, 2010
Primary completion
Aug 27, 2010
Study completion
Aug 27, 2010
Results posted
Not reported
Registry updated
Jun 8, 2017
Outcomes
What the study measures.
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
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- 55 Years
- Sex
- ALL
- Healthy volunteers
- Yes
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 locations
1 registered sites.
United States. Showing up to 24 locations stored in the fast local snapshot.
GSK Investigational Site
Austin, Texas, United States
Publications
Results and literature.
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Put the record in context.
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