A Drug Interaction Study of Simvastatin and Albiglutide
Phase 1
Completed
- Conditions
- Diabetes Mellitus, Type 2
- 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.
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
- 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
GSK Investigational Site🇺🇸Austin, Texas, United States