A Drug Interaction Study of Simvastatin and Albiglutide

NCT01147692 | Completed Phase 1 DMC

• 1 other identifier: 108366
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2

Keywords

albiglutide; simvastatin; healthy volunteers; pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• The effect of albiglutide on the pharmacokinetics of simvastatin

  42 days

Secondary Outcomes (1)

• The pertinent plasma pharmacokinetic parameters of simvastatin with and without albiglutide

  42 days

Study Arms (1)

simvastatin plus albiglutide

EXPERIMENTAL

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.

Biological: simvastatin plus albiglutide

Interventions

simvastatin plus albiglutide BIOLOGICAL

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.

simvastatin plus albiglutide

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Austin, Texas, 78744, United States

Location

Related Publications (1)

• Young MA, Wald JA, Matthews JE, Scott R, Hodge RJ, Zhi H, Reinhardt RR. Clinical pharmacology of albiglutide, a GLP-1 receptor agonist. Postgrad Med. 2014 Nov;126(7):84-97. doi: 10.3810/pgm.2014.11.2836.

  PMID: 25387217 DERIVED

Related Links

• Results for study 108366 can be found on the GSK Clinical Study Register.
• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Simvastatin; rGLP-1 protein

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Lovastatin; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2010
• First Posted: June 22, 2010
• Study Start: May 19, 2010
• Primary Completion: August 27, 2010
• Study Completion: August 27, 2010
• Last Updated: June 8, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will share

Locations

US (1)