A Drug Interaction Study of Simvastatin and Albiglutide

Study Overview
=================
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.

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

Conditions
-----------------
Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Biological: simvastatin plus albiglutide


Participation Criteria
=================
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: simvastatin plus albiglutide<br>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<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effect of albiglutide on the pharmacokinetics of simvastatin |  | 42 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The pertinent plasma pharmacokinetic parameters of simvastatin with and without albiglutide |  | 42 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
albiglutide, simvastatin, healthy volunteers, pharmacokinetics