E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Influenza A virus infection |
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E.1.1.1 | Medical condition in easily understood language |
Influenza A virus infection |
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E.1.1.2 | Therapeutic area | Diseases [C] - Virus Diseases [C02] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 19.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10022002 |
E.1.2 | Term | Influenza A virus infection |
E.1.2 | System Organ Class | 100000004862 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary objective is to evaluate the pharmacokinetic (PK) parameters of JNJ-63623872 in combination with oseltamivir in adolescents (aged 13 to ≤17 years) and elderly subjects (aged 65 to ≤85 years) compared to adults (aged 18 to ≤64 years) with influenza A infection. |
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E.2.2 | Secondary objectives of the trial |
Secondary objectives include the assessment of the following parameters in the JNJ-63623872 treatment arm compared to the control arm:
1. Safety and tolerability.
2. The time to influenza viral negativity based on quantitative reverse transcription polymerase chain reaction (qRT-PCR) and/or viral culture from nasal mid-turbinate (MT) swabs and, if applicable, based on PCR-based rapid molecular testing from nasal MT swabs.
3. Viral load over time and rate of decline in viral load during treatment as measured by qRT-PCR and/or by viral culture.
4. Area under the curve (AUC) of viral load as measured by qRT-PCR and/or by viral culture.
5. Disease status and incidence of complications associated with influenza after the start of study treatment, and disease progression.
6. Change in duration and severity of clinical symptoms as measured by the Flu-PRO.
Additional secondary objectives and exploratory objectives can be found in the protocol: Section 2, pages 29-30 |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Participants requires hospitalization to treat influenza infection and/or to treat complications of influenza infection
- Participants 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
- Participants must be willing and able to adhere to the prohibitions and restrictions specified in the protocol |
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E.4 | Principal exclusion criteria |
- Participants 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 known (considering lab results of the past 6 months) to be severely immunocompromised as defined by a CD4+ count <350 cells/mm^3 or an absolute neutrophil count <750/mm^3.
- 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 |
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E.5 End points |
E.5.1 | Primary end point(s) |
1- Trough Plasma Concentration (Ctrough) of JNJ-63623872
2- Minimum Observed Plasma Concentration (Cmin) of JNJ-63623872
3- Maximum Observed Plasma Concentration (Cmax) of JNJ-63623872
4- Time to Reach Maximum Observed Plasma Concentration (Tmax) of JNJ-63623872
5- Area Under the Plasma Concentration-Time Curve From Time of Administration to 12 hours After Dosing (AUC [0-12]) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
1- Pre-dose, 1.5, 6 and 12 hours post-dose on Day 1; Predose, 1.5 and 6 hours post-dose on Day 2 and 4 to 7; Pre-dose, 1, 2, 4, 6, 8, 10 and 12 hours post-dose on Day 3
2- Pre-dose, 1.5, 6 and 12 hours post-dose on Day 1; Predose, 1.5 and 6 hours post-dose on Day 2 and 4 to 7; Pre-dose, 1, 2, 4, 6, 8, 10 and 12 hours post-dose on Day 3
3- same as above
4- same as above
5- same as above |
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E.5.2 | Secondary end point(s) |
1- Time to Influenza Viral Negativity
2- Viral Load Over Time
3- Rate of Decline in Viral Load
4- Area Under the Plasma Concentration-Time Curve (AUC) of Viral Load
5- Disease Status and Incidence of Complications Associated With Influenza
6- Change in Duration and Severity of Clinical Symptoms
7- Time to Improvement of Vital Signs
8- Time to Improvement of Respiratory Status
9- Emergence of Drug Resistance
10- Time to Return to Premorbid Functional Status
11- Time to Hospital Discharge
12- Time to Significant Reduction in Influenza Symptom Severity
13- Percentage of Participants With a Significant Reduction to Mild or None for all Influenza Symptoms at Each Assessment
14- Number of Participants with Adverse Events (AEs) and Serious AEs
15- Participants Improvement on Ordinal Scale |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 13, 15 - Up to Day 28
14 - Screening up to followup (21 days after last dose administration) |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
- Tolerability
- Biomarker analysis |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 37 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Australia |
Belgium |
Brazil |
Canada |
France |
Germany |
Hong Kong |
Malaysia |
Netherlands |
New Zealand |
Singapore |
Spain |
Sweden |
Turkey |
United States |
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E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 7 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 7 |