Diabetes Mellitus, Type 2
Conditions
Keywords
albiglutide, QT interval, cardiac repolarization, ECG study
Brief summary
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.
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
BIOLOGICALAlbiglutide
once weekly subcutaneous injection
DRUGMoxifloxacin
oral tablet
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| QTc interval | 6 weeks | Measurement of cardiac repolarization after albiglutide dosing |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| QTc interval | Day 4 | Measurement of cardiac repolarization after albiglutide dosing |
| QT interval | Day -1 and Day 40 | Determination of the effect of moxifloxacin on cardiac repolarization |
| Number of participants with adverse events | 6 weeks | Number of participants with adverse events |
Outcome results
None listed