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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03816631 | A Study of Orally Administered Pimodivir in Adult Participants With Hepatic Impairment | PHASE1 | COMPLETED | 42 | — | — | May 28, 2019 | Apr 27, 2020 | Feb 3, 2025 | 2 | Germany |
Cmax is defined as maximum observed analyte concentration of pimodivir.
AUC(last) is defined as the time 0 to the time of the last measurable (non-below quantification limit) concentration of Pimodivir calculated by linear-linear trapezoidal summation.
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(last) and C (last)/ lambda(z); wherein AUC(last) is area under the plasma concentration-time curve from time zero to the time of the last measurable concentration, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant.
| Arm | Type | Description |
|---|---|---|
| Part A: Group 1: Severe hepatic function | EXPERIMENTAL | Participants with severe hepatic function will receive single oral dose of pimodivir 600 milligram (mg) (2\*300 mg tablet) under fasted condition on Day 1. |
| Part A and B: Group 2: Normal hepatic function | EXPERIMENTAL | Participants with normal hepatic function will receive single oral dose of pimodivir 600 mg (2\*300 mg tablet) under fasted condition on Day 1. The recruitment in Part B will be started based on assessment by Sponsor upon evaluation of partial data obtained in Part A. |
| Part B: Group 3: Moderate hepatic function | EXPERIMENTAL | Participants with moderate hepatic function will receive single oral dose of pimodivir 600 mg (2\*300 mg tablet) under fasted condition on Day 1. The recruitment in Part B will be started based on assessment by Sponsor upon evaluation of partial data obtained in Part A. |
| Part B: Group 4: Mild hepatic function | EXPERIMENTAL | Participants with mild hepatic function will receive single oral dose of Pimodivir 600 mg (2\*300 mg tablet) under fasted condition on Day 1. The recruitment in Part B will be started based on assessment by Sponsor upon evaluation of partial data obtained in Part A. |
| Name | Type | Description |
|---|---|---|
| Pimodivir | DRUG | Participants will receive single oral dose of Pimodivir 600 mg (2\*300 mg tablets) under fasted condition on Day 1. |
Inclusion Criteria: * Participant must have a stable hepatic function as confirmed by albumin levels, prothrombin time (PT), International Normalized Ratio (INR), and platelet count measured during screening and those measured within 24 hours prior to study drug administration. Participants with a ...