Last updated: 11/07/2018 02:11:33
A drug interaction study of simvastatin and albiglutide
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: An Open-label, Sequential Study to Evaluate the Pharmacokinetics of Simvastatin When Coadministered With Albiglutide in Healthy Adult Subjects
Trial description: 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.
Primary purpose:
Basic Science
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:
The effect of albiglutide on the pharmacokinetics of simvastatin
Timeframe: 42 days
Secondary outcomes:
The pertinent plasma pharmacokinetic parameters of simvastatin with and without albiglutide
Timeframe: 42 days
Interventions:
Biological/vaccine: simvastatin plus albiglutide
Enrollment:
40
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Malcolm A. Young, Jeffrey A. Wald Jessica E. Matthews, Rhona Scott, Hui Zhi, Rebecca Hodge, Rickey R. Reinhardt. Clinical Pharmacokinetics and Pharmacodynamics of Albiglutide, a GLP-1 Receptor Agonist . Postgrad Med. 2014;7:84-97.
Medical condition
Diabetes Mellitus, Type 2
Product
albiglutide
Collaborators
Not applicable
Study date(s)
May 2010 to August 2010
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
18 - 55 years
Accepts healthy volunteers
Yes
- no clinically significant diseases or clinically significant abnormal laboratory values
- females must be of non-childbearing potential
- positive test results for hepatitis B, hepatitis C or human immunodeficiency virus (HIV)
- any clinically relevant abnormality
Inclusion and exclusion 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)
Trial location(s)
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2010-27-08
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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Additional information
Results for study 108366 can be found on the GSK Clinical Study Register.
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