A Randomized, Phase 1, Three-Period, Placebo- and Positive-Controlled, Double-Blind, Crossover Study to Assess the Electrophysiological Effects of Exenatide at Therapeutic and Supratherapeutic Concentrations on the 12-Lead Electrocardiogram QT Interval in Healthy Subjects

Registration

Registration

NCT01297062

Study type

INTERVENTIONAL

Allocation

RANDOMIZED

Phase

PHASE1

Masking

TRIPLE

Status

COMPLETED

Enrollment

94

Start

2011-02

Primary completion

2011-04

Lead sponsor

AstraZeneca

Conditions

Healthy Subjects

Interventions

DRUG:Exenatide; DRUG:Moxifloxacin; DRUG:Placebo comparator

Results posted

TRUE

Registered primary outcomes

• Comparison of Least Squares (LS) Mean Changes From Baseline in Population-based Corrected QT Intervals (QTcP) Between Exenatide and Placebo on Day 1 Averaged Over 1300h, 1400h, 1500h (Target Steady State Exenatide Concentration of 200 pg/mL) [Baseline, Day 1]
• Comparison of LS Mean Changes From Baseline in QTcP Intervals Between Exenatide and Placebo on Day 2 Averaged Over 1300h, 1400h, 1500h (Target Steady State Exenatide Concentration of 300 pg/mL) [Baseline, Day 2]
• Comparison of LS Mean Changes From Baseline in QTcP Intervals Between Exenatide and Placebo on Day 3 Averaged Over 1300h, 1400h, 1500h (Target Steady State Exenatide Concentration of 500 pg/mL) [Baseline, Day 3]