Last updated: 11/07/2018 03:44:34
A drug interaction study of albiglutide and digoxin
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: An Open-label, Sequential Study to Evaluate the Pharmacokinetics of Digoxin When Coadministered With Albiglutide in Healthy Adult Subjects
Trial description: This Phase I, open-label, sequential, single-center study evaluates the pharmacokinetics of digoxin when coadministered with albiglutide in healthy adult subjects.
Primary purpose:
Basic Science
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:
The pharmacokinetic parameters of digoxin with and without albiglutide
Timeframe: 38 days
Secondary outcomes:
Safety of digoxin with and without albiglutide
Timeframe: 38 days
Interventions:
Biological/vaccine: digoxin plus albiglutide
Enrollment:
30
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Mark Bush, Rhona Scott, Prapoch Watanalumlerd, Hui Zhi & Eric Lewis. The effects of multiple doses of Albiglutide on the pharmacokinetics pharmacodynamics and safety of digoxin, warfarin or a low-dose oral contraceptive. Postgrad Med. 2012;124(6):1-18.
Mark Bush, Rhona Scott, Prapoch Watanalumlerd, Hui Zhi & Eric Lewis. The effects of multiple doses of Albiglutide on the pharmacokinetics pharmacodynamics and safety of digoxin, warfarin or a low-dose oral contraceptive. Postgrad Med. 2012;124(6):55-72.
Medical condition
Diabetes Mellitus, Type 2
Product
albiglutide, digoxin
Collaborators
Not applicable
Study date(s)
June 2010 to November 2010
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
18 - 55 years
Accepts healthy volunteers
Yes
- healthy volunteers
- female subjects must be of nonchildbearing potential
- positive test results for hepatitis B, hepatitis C or human immunodeficiency virus
- female subject is pregnant or breast-feeding
Inclusion and exclusion 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)
Trial location(s)
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2010-29-11
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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