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A Drug Interaction Study of Simvastatin and Albiglutide

Primary Purpose

Diabetes Mellitus, Type 2

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

simvastatin plus albiglutide

About this trial

This is an interventional basic science trial for Diabetes Mellitus, Type 2 focused on measuring albiglutide, simvastatin, healthy volunteers, pharmacokinetics

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

GSK Investigational Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

simvastatin plus albiglutide

Arm Description

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.

Outcomes

Primary Outcome Measures

The effect of albiglutide on the pharmacokinetics of simvastatin

Secondary Outcome Measures

The pertinent plasma pharmacokinetic parameters of simvastatin with and without albiglutide

Full Information

NCT ID

NCT01147692

First Posted

April 29, 2010

Last Updated

June 7, 2017

Sponsor

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT01147692

Brief Title

A Drug Interaction Study of Simvastatin and Albiglutide

Official Title

An Open-label, Sequential Study to Evaluate the Pharmacokinetics of Simvastatin When Coadministered With Albiglutide in Healthy Adult Subjects

Study Type

Interventional

2. Study Status

Record Verification Date

June 2017

Overall Recruitment Status

Completed

Study Start Date

May 19, 2010 (Actual)

Primary Completion Date

August 27, 2010 (Actual)

Study Completion Date

August 27, 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

GlaxoSmithKline

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus, Type 2

Keywords

albiglutide, simvastatin, healthy volunteers, pharmacokinetics

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

simvastatin plus albiglutide

Arm Type

Experimental

Arm Description

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.

Intervention Type

Biological

Intervention Name(s)

simvastatin plus albiglutide

Intervention Description

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.

Primary Outcome Measure Information:

Title

The effect of albiglutide on the pharmacokinetics of simvastatin

Time Frame

42 days

Secondary Outcome Measure Information:

Title

The pertinent plasma pharmacokinetic parameters of simvastatin with and without albiglutide

Time Frame

42 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility 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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

GSK Clinical Trials

Organizational Affiliation

GlaxoSmithKline

Official's Role

Study Director

Facility Information:

Facility Name

GSK Investigational Site

City

Austin

State/Province

Texas

ZIP/Postal Code

78744

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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.

Citations:

PubMed Identifier

25387217

Citation

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.

Results Reference

derived

Links:

URL

https://www.clinicalstudydatarequest.com

Description

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Available IPD and Supporting Information:

Available IPD/Information Type

Statistical Analysis Plan

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

108366

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Dataset Specification

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

108366

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Informed Consent Form

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

108366

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Individual Participant Data Set

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

108366

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Annotated Case Report Form

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

108366

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Study Protocol

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

108366

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Clinical Study Report

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

108366

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Learn more about this trial

A Drug Interaction Study of Simvastatin and Albiglutide

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