A Drug Interaction Study of Albiglutide and Digoxin



Status:Completed
Conditions:Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - 55
Updated:12/2/2016
Start Date:June 2010
End Date:November 2010

Use our guide to learn which trials are right for you!

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

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

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.

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)
We found this trial at
1
site
Austin, Texas 78705
?
mi
from
Austin, TX
Click here to add this to my saved trials