Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02961660 | A Study to Evaluate the Effect of Severe Renal Impairment on the Single-dose Pharmacokinetics of Odalasvir | PHASE1 | COMPLETED | 16 | — | — | Nov 9, 2016 | Apr 9, 2018 | Feb 3, 2025 | 2 | United States |
The Cmax is the maximum observed plasma analyte concentration.
The Tmax is defined as actual sampling time to reach maximum observed analyte concentration.
The AUC (0-24) is the area under the plasma concentration-time curve from time zero to 24 hours.
The AUC (0-72) is the area under the plasma concentration-time curve from time zero to 72 hours.
The AUC (0-last) is the area under the plasma concentration-time curve from time zero to last quantifiable time.
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.
Elimination half-life associated with the terminal slope Lambda (z) of the semi logarithmic drug concentration-time curve, calculated as 0.693/Lambda (z).
The Vd/F is defined as Dose/\[Lambda (z)\*AUC (0-infinity)\].
The CL/F is defined as Dose/AUC (0-infinity).
| Arm | Type | Description |
|---|---|---|
| Cohort 1 (Severe Renal Impairment): Odalasvir | EXPERIMENTAL | Participants will receive single oral dose of odalasvir 25 milligram (mg) under fed conditions (standard breakfast) on Day 1. |
| Cohort 2 (Normal Renal Function): Odalasvir | EXPERIMENTAL | Participants will receive single oral dose of odalasvir 25 milligram (mg) under fed conditions (standard breakfast) on Day 1. |
| Name | Type | Description |
|---|---|---|
| Odalasvir | DRUG | Participants will receive odalasvir 25 mg tablet, orally. |
Inclusion Criteria: Cohorts 1 and 2: * Participant must have a body mass index (BMI; weight in kilogram (kg) divided by the square of height in meters) of 18 to 36 kilogram per meter square (kg/m\^2), extremes included, and a body weight not less than 50.0 kg * Participant must be willing and able...