Approval Probability
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Also known as JNJ-63623872
Pimodivir · 2 trials · 2 indications
Cmax is the maximum observed plasma concentration. As per planned analysis, results are presented by age groups (65 to less than or equal to \[\<=\] 85 years and 18 to \<=64 years).
Cmin is the minimum observed plasma concentration. As per planned analysis, results are presented by age groups (65 to \<= 85 years and 18 to \<=64 years).
AUC (0-12) is the area under the plasma concentration-time curve from time zero to 12 hours after dosing of pimodivir. As per planned analysis, results are presented by age groups (65 to \<= 85 years and 18 to \<=64 years).
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 |
|---|---|---|
| JNJ-63623872 plus Oseltamivir | EXPERIMENTAL | Participants will be administered JNJ-63623872 600 milligram (mg) tablets and oseltamivir 75 mg capsules orally twice daily for 7 days. |
| Placebo plus Oseltamivir | EXPERIMENTAL | Participants will be administered placebo tablets and oseltamivir 75 mg capsules orally twice daily for 7 days. |
| 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 |
|---|---|---|
| JNJ-63623872 | DRUG | Participants will be administered JNJ-63623872 600 milligram (mg) tablets orally twice daily for 7 days. |
| Placebo | DRUG | Participants will be administered placebo tablets orally twice daily for 7 days. |
| Oseltamivir | DRUG | Participants will be administered oseltamivir 75 mg capsules orally twice daily for 7 days. |
| 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 requires hospitalization to treat influenza infection and/or to treat complications of influenza infection * Participant tested positive for influenza A infection within 1 day of signing of the informed consent form (ICF)/assent form using a polymerase chain reacti...
Pimodivir is a small molecule drug developed by Johnson & Johnson that has been studied in a Phase 1 clinical trial in adult participants with hepatic impairment. It is an investigational agent and is not approved for any indication.
Pimodivir has been evaluated in a Phase 1 study of orally administered drug in adults with hepatic impairment. The trial enrolled 42 participants in Germany and has been completed. It remains investigational and is not approved for treating hepatic impairment or any other condition.
Pimodivir is developed by Johnson & Johnson, which trades under the ticker JNJ. The company sponsored the Phase 1 trial of orally administered Pimodivir in adult participants with hepatic impairment.
Pimodivir is in Phase 1 development. One Phase 1 trial has been completed, and no trials are currently active. The drug is investigational and has not received FDA approval for any indication.
Pimodivir has been studied in one completed Phase 1 trial, NCT03816631, titled A Study of Orally Administered Pimodivir in Adult Participants With Hepatic Impairment. The trial enrolled 42 adults in Germany and included healthy volunteers.
Pimodivir is not approved. It is an investigational small molecule in Phase 1 clinical development, with one completed trial in adults with hepatic impairment. No regulatory approval has been granted for any indication.