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

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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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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