- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01147692
A Drug Interaction Study of Simvastatin and Albiglutide
June 7, 2017 updated by: GlaxoSmithKline
An Open-label, Sequential Study to Evaluate the Pharmacokinetics of Simvastatin When Coadministered With Albiglutide in Healthy Adult Subjects
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Texas
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Austin, Texas, United States, 78744
- GSK Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
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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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The effect of albiglutide on the pharmacokinetics of simvastatin
Time Frame: 42 days
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42 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The pertinent plasma pharmacokinetic parameters of simvastatin with and without albiglutide
Time Frame: 42 days
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42 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 19, 2010
Primary Completion (Actual)
August 27, 2010
Study Completion (Actual)
August 27, 2010
Study Registration Dates
First Submitted
April 29, 2010
First Submitted That Met QC Criteria
June 17, 2010
First Posted (Estimate)
June 22, 2010
Study Record Updates
Last Update Posted (Actual)
June 8, 2017
Last Update Submitted That Met QC Criteria
June 7, 2017
Last Verified
June 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Glucose Metabolism Disorders
- Metabolic Diseases
- Endocrine System Diseases
- Diabetes Mellitus
- Diabetes Mellitus, Type 2
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antimetabolites
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Anticholesteremic Agents
- Hypolipidemic Agents
- Lipid Regulating Agents
- Hydroxymethylglutaryl-CoA Reductase Inhibitors
- Incretins
- Simvastatin
- rGLP-1 protein
Other Study ID Numbers
- 108366
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Study Data/Documents
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Statistical Analysis Plan
Information identifier: 108366Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Dataset Specification
Information identifier: 108366Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Informed Consent Form
Information identifier: 108366Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Individual Participant Data Set
Information identifier: 108366Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Annotated Case Report Form
Information identifier: 108366Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Study Protocol
Information identifier: 108366Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Clinical Study Report
Information identifier: 108366Information comments: For additional information about this study please refer to the GSK Clinical Study Register
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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