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

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Healthy Subjects

Treatments: Drug: Exenatide; Drug: Placebo comparator; Drug: Moxifloxacin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01297062

BCB112

Details and patient eligibility

About

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

Enrollment: 94 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

94 participants in 3 patient groups, including a placebo group

Exenatide

Experimental group

Treatment:

Drug: Exenatide

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo comparator

Moxifloxacin

Active Comparator group

Treatment:

Drug: Moxifloxacin