BIOLOGICAL
Albiglutide
once weekly subcutaneous injection
Albiglutide Thorough ECG Study in Healthy Volunteers
Status
Completed
Phase
Phase 1
Enrollment
94
Locations
0
Results
Not posted
Publications
1
Study summary
What the protocol is testing.
This study is designed to investigate the effect of treatment with albiglutide on the cardiac repolarization (corrected QT interval) in healthy male and female subjects. Moxifloxacin, a positive control, or moxifloxacin placebo will be given in order to validate the ability of the study to detect a change in the corrected QT interval.
Full detailed description
This is a Phase I, randomized, double-blind study designed to investigate the effect of treatment with albiglutide given weekly over 6 weeks on the cardiac repolarization (corrected QT interval) in healthy male and female subjects. Moxifloxacin, a positive control, or moxifloxacin placebo will be given in order to validate the ability of the study to detect a change in the corrected QT interval.
Interventions
Treatment arms and agents.
DRUG
Moxifloxacin
oral tablet
Timeline
From registration to results.
First posted
Aug 1, 2011
Study start
Jul 6, 2011
Primary completion
Dec 29, 2011
Study completion
Dec 29, 2011
Results posted
Not reported
Registry updated
Jun 8, 2017
Outcomes
What the study measures.
Primary outcomes
QTc interval
Time frame · 6 weeks
Measurement of cardiac repolarization after albiglutide dosing
Secondary outcomes
QTc interval
Time frame · Day 4
Measurement of cardiac repolarization after albiglutide dosing
QT interval
Time frame · Day -1 and Day 40
Determination of the effect of moxifloxacin on cardiac repolarization
Number of participants with adverse events
Time frame · 6 weeks
Number of participants with adverse events
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- 45 Years
- Sex
- ALL
- Healthy volunteers
- Yes
Inclusion Criteria: * Healthy male or nonpregnant, nonlactating female * Subject considered to be in good health as judged by the absence of clinically significant diseases or clinically significant abnormal laboratory values * BMI is ≥18 kg/m2 and ≤30 kg/m2 * Nonsmoker Exclusion Criteria: * Positive test results for hepatitis B, hepatitis C, or human immunodeficiency virus * History of arrythmia or use of antiarrhythmic agents * History of any anaphylactic reaction to any drug * History of significant cardiovascular or pulmonary dysfunction * Current or chronic history of liver disease , renal disease, CNS disorders, thyroid dysfunction, rheumatoid arthritis * History of alcohol or substance abuse * History of GI surgery that could influence gastric emptying * Female and using oral contraception (combined or progestogen only), implants or levonorgestrel, or injectable progesterone, or hormone replacement therapy * History of pancreatitis
Study locations
0 registered sites.
No country data reported. Showing up to 24 locations stored in the fast local snapshot.
No study locations reported.
Publications
Results and literature.
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