Albiglutide Thorough ECG Study in Healthy Volunteers

• QTc interval [ Time Frame: Day 4 ] [ Designated as safety issue: No ]
  Measurement of cardiac repolarization after albiglutide dosing
• QT interval [ Time Frame: Day -1 and Day 40 ] [ Designated as safety issue: No ]
  Determination of the effect of moxifloxacin on cardiac repolarization
• Number of participants with adverse events [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  Number of participants with adverse events

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.

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.

• Biological: Albiglutide
  once weekly subcutaneous injection
• Drug: Moxifloxacin
  oral tablet

• Active Comparator: Albiglutide + moxifloxacin placebo
  Once weekly subcutaneous injection of albiglutide for 6 weeks plus oral tablet of moxifloxacin matching placebo on Days -1 and 40
  Intervention: Biological: Albiglutide
• Active Comparator: Albiglutide matching placebo + moxifloxacin
  Once weekly subcutaneous injection of albiglutide matching placebo for 6 weeks, given with oral 400mg moxifloxacin tablet on Day -1 and moxifloxacin matching placebo on Day 40, or weekly albiglutide matching placebo for 6 weeks plus oral moxifloxacin matching placebo on Day -1 then oral 400mg moxifloxacin on Day 40
  Intervention: Drug: Moxifloxacin

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