The purpose of this study is to determine the relationship between the plasma concentrations of odalasvir and changes in the QT interval / QTc interval (QT corrected for heart rate) using exposure-response (ER) analysis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
60
Participants will receive odalasvir 2\*50 mg tablet, orally once on Day 1.
Participants will receive odalasvir matching placebo, tablet, orally once on Day 1.
Participants will receive odalasvir 10\*50 mg tablet, orally once on Day 1.
Unnamed facility
Tempe, Arizona, United States
The Relationship Between the Plasma Concentrations of Odalasvir and Changes in the QT/QTc Interval Using Exposure-response (ER) Analysis
A linear mixed-effects model will assess the effect of dose and treatment on the change from baseline in QTc over time.
Time frame: Baseline up to Day 4
Maximum Plasma Concentration (Cmax) of Odalasvir
Cmax is the maximum observed analyte concentration.
Time frame: 0 hour (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16, 24, 30, 36, 48, 72 and 120 hours post-dose on Day 1
Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Time (AUC [0-last]) of Odalasvir
AUC(0-last) is the area under the plasma concentration-time curve from time zero to the last quantifiable time.
Time frame: 0 hour (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16, 24, 30, 36, 48, 72 and 120 hours post-dose on Day 1
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity]) of Odalasvir
The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC(0-last) and C(last)/lambda(z); wherein AUC(0-last) is area under the plasma concentration-time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant.
Time frame: 0 hour (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16, 24, 30, 36, 48, 72 and 120 hours post-dose on Day 1
PR Interval Changes and the Relationship Between the Plasma Concentrations of Odalasvir and PR Interval Changes Using ER Analysis
A linear mixed-effects model will assess the effect of dose and treatment on the change from baseline in the PR interval over time.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Participants will receive odalasvir to be decided up to maximum of 20\*50 mg tablet, orally once on Day 1.
Time frame: Baseline up to Day 4
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Time frame: up to Day 65