Phase 2
Completed N=99
A Study to Evaluate the Pharmacokinetics, Safety, and Antiviral Activity of JNJ-63623872 in Combination With Oseltamivir in Adult, and Elderly Hospitalized Participants With Influenza A Infection
Influenza A Virus
Source: ClinicalTrials.gov NCT02532283 ↗
Enrolled (actual)
99
Serious AEs
15.2%
Results posted
Mar 2020
Primary outcomePrimary: Maximum Observed Plasma Concentration (Cmax) of Pimodivir — 5933; 5378 Nanogram per milliliter (ng/mL)
Summary
The purpose of this study is to evaluate the Pharmacokinetic parameters of JNJ-63623872 in combination with oseltamivir in elderly participants (aged 65 to <= 85 years) compared to adults (aged 18 to <= 64 years) with influenza A infection.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Observed Plasma Concentration (Cmax) of Pimodivir |
5933; 5378 | — |
| PRIMARY Minimum Observed Plasma Concentration (Cmin) of Pimodivir |
738; 507 | — |
| PRIMARY Area Under the Plasma Concentration-time Curve From Time of Administration to 12 Hours After Dosing (AUC [0-12]) of Pimodivir |
27386; 20101 | — |
| SECONDARY Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious AEs (TESAEs) |
48; 25; 11; 4 | — |
| SECONDARY Time to Influenza A Viral Negativity |
9.53; 9.74 | — |
| SECONDARY Influenza Viral Load Over Time |
5.45; 5.90; 6.40; 4.43; 4.75; 4.63 | — |
| SECONDARY Rate of Decline in Viral Load |
-0.35; -0.42 | — |
| SECONDARY Area Under the Plasma Concentration-time Curve (AUC) of Viral Load |
22.8; 22.1 | — |
| SECONDARY Percentage of Participants With Influenza Complications |
7.9; 15.6; 0; 0; 1.6; 3.1 | — |
| SECONDARY Change From Baseline in Influenza Patient-Reported Outcome Questionnaire (FLU-PRO) Total Score |
-0.08; -0.11; -0.48; -0.33; -0.60; -0.52 | — |
| SECONDARY Time to Improvement of Vital Signs |
169.92; 69.90 | — |
| SECONDARY Time to Improvement of Respiratory Status |
33.53; 40.57 | — |
| SECONDARY Percentage of Participants With Clinical Outcome Based on Ordinal Scale |
40.3; 29.0; 27.4; 45.2; 14.5; 6.5 | — |
| SECONDARY Number of Participants With the Emergence of Drug Resistance Mutations With Oseltamivir (OST) and Pimodivir |
0; 0; 0; 1 | — |
| SECONDARY Time to Return to Premorbid Functional Status |
142.85; 154.83 | — |
| SECONDARY Time to Hospital Discharge |
4.00; 4.00 | — |
| SECONDARY Time to Return to Usual Health |
217.05; 338.83 | — |
| SECONDARY Time to Significant Reduction in FLU-PRO Influenza Symptom Severity |
118.45; 218.72 | — |
| SECONDARY Percentage of Participants With Significant Reduction in FLU-PRO All Influenza Symptoms (Mild or None for All Symptoms) |
9.4; 18.2; 37.3; 34.6; 36.4; 26.7 | — |
Eligibility Criteria
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 reaction (PCR)-based rapid molecular diagnostic assay
- Participants must be capable of swallowing study medication tablets and capsules
- Each participant (or their legally acceptable representative) must sign an ICF indicating that he or she understands the purpose of and procedures required for the study and is willing to participate in the study
- Participant must be willing and able to adhere to the prohibitions and restrictions specified in the protocol
Exclusion Criteria
- Participant received more than 3 doses of the influenza antiviral medication oseltamivir, zanamivir, or peramivir since the start of the influenza symptoms, or ribavirin within 6 months prior to Screening
- Participant is unwilling to undergo regular nasal Mid-turbinate (MT) swabs or has any physical abnormality which limits the ability to collect regular nasal specimens
- Participant is immunocompromised, whether due to underlying medical condition (example, malignancy) or medical therapy (example, medications, chemotherapy, radiation, post-transplant)
- Participant is undergoing peritoneal dialysis, hemodialysis, or hemofiltration
- Participant has an estimated glomerular filtration rate (eGFR) less than or equal to (<=)30 milliliter (mL)/minute (min)/1.73 meter^2 (m^2) according to the Modification of Diet in Renal Disease (MDRD) equation, assessed at Screening or based on the most recent clinically relevant creatinine value if available
Data sourced from ClinicalTrials.gov (NCT02532283). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.