A Drug Interaction Study of Albiglutide and Digoxin

Study Overview
=================
Brief Summary
-----------------
This Phase I, open-label, sequential, single-center study evaluates the pharmacokinetics of digoxin when coadministered with albiglutide in healthy adult subjects.

Detailed Description
-----------------
This Phase I, open-label, sequential, single-center study evaluates the pharmacokinetics of digoxin when coadministered with albiglutide in healthy adult subjects. Subjects will receive a single dose of digoxin on Day 1 followed by 5 weekly subcutaneously injected doses of albiglutide and a second single dose of digoxin on Day 38. To determine the plasma pharmacokinetic parameters of digoxin after drug administration alone and after multiple doses of albiglutide, blood samples will be collected after each dose of digoxin.

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

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

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy volunteers female subjects must be of nonchildbearing potential no clinically significant diseases or clinically significant abnormal laboratory values body mass index (BMI) is >/=18 kg and ≤30 kg/m2 a nonsmoker Exclusion Criteria: positive test results for hepatitis B, hepatitis C or human immunodeficiency virus 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 disease or dysfunction history of gastrointestinal surgery or disease history of pancreatitis history of cholecystitis or other gallbladder disease 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: digoxin plus albiglutide<br>A single dose of 0.5mg digoxin administered on Day 1 followed by 5 weekly subcutaneous injections of albiglutide, followed by a further single dose of 0.5mg digoxin on Day 38. | Biological: digoxin plus albiglutide<br>* A single dose of 0.5mg digoxin on Day 1 followed by 5 weekly doses of subcutaneous albiglutide, followed by a single dose of 0.5mg digoxin on Day 38.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The pharmacokinetic parameters of digoxin with and without albiglutide |  | 38 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of digoxin with and without albiglutide |  | 38 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pharmacokinetics, albiglutide, Healthy volunteer, digoxin