A Study to Evaluate the Effects of E2609 on QTc Interval in Healthy Subjects
- Registration Number
- NCT02222324
- Lead Sponsor
- Eisai Inc.
- Brief Summary
This thorough QT (TQT) study will take place in healthy subjects administered single doses of study drug. It will be a randomized, double-blind, placebo and active-controlled, 4-treatment crossover study. Subjects will be randomized in an equal ratio to one of 12 possible treatment sequences. Each treatment sequence will comprise all 4 treatments.
- Detailed Description
The study will consist of 2 phases: Prerandomization and Randomization. The Prerandomization Phase will have 2 periods: Screening (up to 27 days) and Baseline Period 1 (1 day). Eligibility will be determined during the Screening Period. The Randomization Phase will consist of 8 periods: Treatment Period 1, Baseline Period 2, Treatment Period 2, Baseline Period 3, Treatment Period 3, Baseline Period 4, Treatment Period 4, and a Follow-Up Period. Each Baseline Period will last 1 day, followed by the corresponding treatment period. On the first day of each treatment period, subjects will receive a single dose of the assigned study drug. During each treatment period, subjects will be required to stay in the clinical unit from the baseline period to 24 hours postdose. Subjects will then be released from the clinic and will undergo a washout interval of at least 13 days, during which time they will return for additional PK sampling.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Treatment A Placebo Placebo Treatment B E2609 E2609 Low dose Treatment C E2609 E2609 High dose Treatment D Moxifloxacin Moxifloxacin
- Primary Outcome Measures
Name Time Method Change from baseline in QTcF obtained from ECGs extracted from the Holter recordings Up to 24 hours postdose during each treatment period Holter recordings are taken from a portable device for continuously monitoring various electrical activity of the cardiovascular system for at least 24 hours. Baseline is defined as the mean of predose QTcF values obtained from ECGs extracted from Holter recordings before dosing during each treatment period.
- Secondary Outcome Measures
Name Time Method Change from baseline in ECG recordings: T wave morphology Predose and then at up to 24 hours postdose in each treatment period Electrocardiograms will be extracted from the continuous digital recording at 3 predose time points. Other time points may be evaluated as well.
Pharmacokinetics of E2609: Cmax Up to 84 Days Maximum drug concentration
Pharmacokinetics of E2609: tmax Up to 84 Days Ttime to reach maximum (peak) concentration following drug administration
Change from baseline in ECG recordings: PR interval Predose and then up to 24 hours postdose in each treatment period Electrocardiograms will be extracted from the continuous digital recording at 3 predose time points. Other time points may be evaluated as well.
Change from baseline in ECG recordings: QRS interval Predose and then up to 24 hours postdose in each treatment period Electrocardiograms will be extracted from the continuous digital recording at 3 predose time points. Other time points may be evaluated as well.
Change from baseline in ECG recordings: HR Predose and then up 24 hours postdose in each treatment period Electrocardiograms will be extracted from the continuous digital recording at 3 predose time points. Other time points may be evaluated as well.
Change from baseline in ECG recordings: RR interval Predose and then at up to 24 hours postdose in each treatment period Electrocardiograms will be extracted from the continuous digital recording at 3 predose time points. Other time points may be evaluated as well.
Pharmacokinetics of E2609: AUC(0-t) Up to 84 Days Area under the concentration x time curve from time = 0 to time of last measurable concentration
Pharmacokinetics of E2609: AUC(0-72h) Up to 84 Days Area under the concentration x time curve from time = 0 to 72 hours postdose
Pharmacokinetics of E2609: AUC(0-inf) Up to 84 Days Area under the concentration x time curve from time = 0 to infinity
Pharmacokinetics of E2609: t1/2 Up to 84 Days Terminal elimination half-life
Pharmacokinetics of E2609: CL/F Up to 84 Days Apparent total clearance following extravascular administration
Pharmacokinetics of E2609: Vz/F Up to 84 Days Apparent volume of distribution following extravascular administration