Status:
COMPLETED
Albiglutide Thorough ECG Study in Healthy Volunteers
Lead Sponsor:
GlaxoSmithKline
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
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 contr...
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 he...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 6 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 29 2011
Estimated Enrollment :
94 Patients enrolled
Trial Details
Trial ID
NCT01406262
Start Date
July 6 2011
End Date
December 29 2011
Last Update
June 8 2017
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