Albiglutide Thorough ECG Study in Healthy Volunteers

• Status: Completed
• Trial end date: 2011-12-29
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Fluoroquinolones; Glucagon-Like Peptide 1; Moxifloxacin; Norgestimate, ethinyl estradiol drug combination; rGLP-1 protein

Criteria

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