A Safety Study to Assess the Effects of Therapeutic and Supratherapeutic Exenatide Concentrations on QT Interval in Healthy Subjects

• Status: Completed
• Trial end date: 2011-05-01
• Target enrollment: 0
• Participant gender: All

Summary

Compare the effect of exenatide (therapeutic and supratherapeutic concentrations), moxifloxacin and placebo on the QT interval.

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

Details

• Lead Sponsor: AstraZeneca
• Collaborator: Eli Lilly and Company
• Treatments: Exenatide; Fluoroquinolones; Moxifloxacin; Norgestimate, ethinyl estradiol drug combination

Criteria

Inclusion Criteria:

• Is overtly healthy, as determined by medical history and physical examination

• Has body mass index (BMI) between 25 and 35 kg/m2

• Has fasting serum glucose <110 mg/dL

• Has no clinically significant blood pressure or heart rate readings as judged by the investigator at study start

• Has electrocardiogram (ECG) results judged as not clinically significant by the investigator at study start

Exclusion Criteria:

• Has a clinically significant medical condition that could potentially affect study participation and/or personal well-being

• Has an abnormality in the 12-lead ECG that, in the opinion of the investigator, increases the risk of participating in the study, such as a Bazett's corrected QT (QTcB) interval >450 ms.

• Family history of sudden death

• Personal history of unexplained syncope within last year, or family history of Long QT Syndrome, or significant active cardiac disease, or symptoms of angina pectoris or transient ischemic attacks within the previous 6 months