Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Pimodivir · 2 trials · 2 indications
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.
Cmax is defined as maximum observed plasma concentration.
AUC(0-Last) is area under the plasma concentration-time curve from time zero to time of the last measurable (non-below quantification limit) concentration, calculated by linear-linear trapezoidal summation.
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); where C(last) is the last observed measurable (non-below quantification limit) concentration.
| 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. |
| Group 1: Sequence AB | EXPERIMENTAL | Participants will receive Treatment A (pimodivir 600 milligram \[mg\] orally as two tablets of 300 mg each) on Day 1 in Period 1 followed by Treatment B (pimodivir 600 mg as two tablets of 300 mg each plus cyclosporine 400 mg orally as four capsules of 100 mg each) on Day 1 in Period 2. Study drug intake in subsequent treatment periods will be separated by a washout period of at least 14 days. |
| Group 2: Sequence BA | EXPERIMENTAL | Participants will receive Treatment B on Day 1 in Period 1 followed by Treatment A on Day 1 in Period 2. Study drug intake in subsequent treatment periods will be separated by a washout period of at least 14 days. |
| 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. |
| Cyclosporine | DRUG | Participants will be administered cyclosporine 400 mg orally as 4 capsules of 100 mg each. |
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 ...
Pimodivir is an investigational small molecule being studied in healthy adults and in adults with hepatic impairment. It is being developed by Johnson & Johnson (JNJ). The drug is currently in Phase 1 clinical development and is not approved for any indication.
Pimodivir is being developed by Johnson & Johnson, which trades under the ticker JNJ. The company is conducting Phase 1 clinical trials to evaluate the drug in healthy volunteers and in participants with hepatic impairment.
Pimodivir is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Clinical trials are ongoing to assess its safety and pharmacokinetics in healthy adults and in individuals with hepatic impairment.
Pimodivir has been studied in two completed Phase 1 trials. NCT03768609 evaluated the effect of cyclosporine on Pimodivir in healthy adults in Belgium, enrolling 18 participants. NCT03816631 studied orally administered Pimodivir in adults with hepatic impairment in Germany, enrolling 42 participants.
Pimodivir is also known by the code name JNJ-63623872. It is a small molecule being developed by Johnson & Johnson. The drug is currently in Phase 1 clinical trials for healthy adults and those with hepatic impairment.