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 |
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.
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.
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)
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