A Drug Interaction Study of Simvastatin and Albiglutide

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01147692

Enrollment

Registered

2010-06-22

Start date

2010-05-19

Completion date

2010-08-27

Last updated

2017-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2

Keywords

albiglutide, simvastatin, healthy volunteers, pharmacokinetics

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.

Interventions

BIOLOGICALsimvastatin 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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)

Design outcomes

Primary

Measure	Time frame
The effect of albiglutide on the pharmacokinetics of simvastatin	42 days

Secondary

Measure	Time frame
The pertinent plasma pharmacokinetic parameters of simvastatin with and without albiglutide	42 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 19, 2026