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

• Register: EUCTR
• Last refreshed on: 19 March 2018
• Main ID: EUCTR2015-003002-17-DE
• Date of registration: 30/09/2015
• Prospective Registration: Yes
• Primary sponsor: Janssen-Cilag International NV
• Public title: 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
• Scientific title: A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Pharmacokinetics, Safety, and Antiviral Activity of JNJ-63623872 in Combination With Oseltamivir Adult and Elderly Hospitalized Patients With Influenza A Infection
• Date of first enrolment: 16/12/2015
• Target sample size: 90
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-003002-17
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: no; Single blind: no; Double blind: yes; Parallel group: no; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: yes; Other: no; Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Australia, Belgium, Brazil, Canada, France, Germany, Hong Kong, Malaysia, Netherlands, New Zealand, Singapore, Spain, Sweden, Turkey, United States

Contacts

• Name: Clinical Registry Group
• Affiliation: Janssen-Cilag International NV

• Name: Clinical Registry Group
• Affiliation: Janssen-Cilag International NV

Key inclusion & exclusion criteria

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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

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


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Virus Diseases [C02]

Influenza A virus infection
MedDRA version: 19.0 Level: LLT Classification code 10022002 Term: Influenza A virus infection System Organ Class: 100000004862

Intervention(s)

Product Name: JNJ-63623872
Product Code: JNJ-63623872
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: JNJ-63623872-ZCD
Other descriptive name: JNJ-63623872-ZCD
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 300-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

Trade Name: Tamiflu
Product Name: Tamiflu
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Oseltamivir
CAS Number: 204255-11-8
Other descriptive name: OSELTAMIVIR PHOSPHATE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 75-

Trade Name: Tamiflu
Product Name: Tamiflu
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Oseltamivir
CAS Number: 204255-11-8
Other descriptive name: OSELTAMIVIR PHOSPHATE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 30-

Primary Outcome(s)

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])

Main Objective: The primary objective is to evaluate the pharmacokinetic (PK) parameters of JNJ-63623872 in combination with oseltamivir in elderly subjects (aged 65 to =85 years) compared to adults (aged 18 to =64 years) with influenza A infection.

Secondary Objective: 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

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

Secondary Outcome(s)

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

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)

Secondary ID(s)

2015-003002-17-SE

63623872FLZ2002

Source(s) of Monetary Support

Janssen R&D, LLC