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

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy Subjects

In brief

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

Key facts

Study ID

NCT01297062

Run by

AstraZeneca

People needed

94

Starts

2011-02-01

Expected to finish

2011-05-01

Last updated by the study team

2015-04-14

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Research Site — Daytona Beach, Florida, United States
• Research Site — Evansville, Indiana, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.