Status:
COMPLETED
A Drug Interaction Study of Albiglutide and Digoxin
Lead Sponsor:
GlaxoSmithKline
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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 ...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
June 11 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 29 2010
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01147718
Start Date
June 11 2010
End Date
November 29 2010
Last Update
June 12 2017
Active Locations (1)
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1
GSK Investigational Site
Austin, Texas, United States, 78744