BIOLOGICAL
digoxin plus albiglutide
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.
A Drug Interaction Study of Albiglutide and Digoxin
Status
Completed
Phase
Phase 1
Enrollment
30
Locations
1
Results
Not posted
Publications
2
Study summary
What the protocol is testing.
This Phase I, open-label, sequential, single-center study evaluates the pharmacokinetics of digoxin when coadministered with albiglutide in healthy adult subjects.
Full 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.
Interventions
Treatment arms and agents.
Timeline
From registration to results.
First posted
Jun 22, 2010
Study start
Jun 11, 2010
Primary completion
Nov 29, 2010
Study completion
Nov 29, 2010
Results posted
Not reported
Registry updated
Jun 12, 2017
Outcomes
What the study measures.
Primary outcomes
The pharmacokinetic parameters of digoxin with and without albiglutide
Time frame · 38 days
Secondary outcomes
Safety of digoxin with and without albiglutide
Time frame · 38 days
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- 55 Years
- Sex
- ALL
- Healthy volunteers
- Yes
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)
Study locations
1 registered sites.
United States. Showing up to 24 locations stored in the fast local snapshot.
GSK Investigational Site
Austin, Texas, United States
Publications
Results and literature.
PMID 23322139 ↗Bush M, Scott R, Watanalumlerd P, Zhi H, Lewis E. Effects of multiple doses of albiglutide on the pharmacokinetics, pharmacodynamics, and safety of digoxin, warfarin, or a low-dose oral contraceptive. Postgrad Med. 2012 Nov;124(6):55-72. doi: 10.3810/pgm.2012.11.2613.PMID 25387217 ↗Young MA, Wald JA, Matthews JE, Scott R, Hodge RJ, Zhi H, Reinhardt RR. Clinical pharmacology of albiglutide, a GLP-1 receptor agonist. Postgrad Med. 2014 Nov;126(7):84-97. doi: 10.3810/pgm.2014.11.2836.
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