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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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT02532283
First received: August 21, 2015
Last updated: June 22, 2017
Last verified: June 2017
  Purpose
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.

Condition Intervention Phase
Influenza A Virus Drug: JNJ-63623872 Drug: Placebo Drug: Oseltamivir Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator
Primary Purpose: Treatment
Official 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 in Adult and Elderly Hospitalized Patients With Influenza A Infection

Resource links provided by NLM:


Further study details as provided by Janssen Research & Development, LLC:

Primary Outcome Measures:
  • Trough Plasma Concentration (Ctrough) of JNJ-63623872 [ Time Frame: Pre-dose, 1.5, 6 and 12 hours post-dose on Day 1; Pre-dose, 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 ]
    The Ctrough is the plasma concentration before dosing or at the end of the dosing interval of any dose other than the first dose in a multiple dosing regimen.

  • Minimum Observed Plasma Concentration (Cmin) of JNJ-63623872 [ Time Frame: Pre-dose, 1.5, 6 and 12 hours post-dose on Day 1; Pre-dose, 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 ]
    The Cmin is the minimum observed plasma concentration.

  • Maximum Observed Plasma Concentration (Cmax) of JNJ-63623872 [ Time Frame: Pre-dose, 1.5, 6 and 12 hours post-dose on Day 1; Pre-dose, 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 ]
    The Cmax is the maximum observed plasma concentration.

  • Time to Reach Maximum Observed Plasma Concentration (Tmax) of JNJ-63623872 [ Time Frame: Pre-dose, 1.5, 6 and 12 hours post-dose on Day 1; Pre-dose, 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 ]
    The Tmax is defined as actual sampling time to reach maximum observed concentration of JNJ-63623872.

  • Area Under the Plasma Concentration-Time Curve From Time of Administration to 12 hours After Dosing (AUC [0-12]) [ Time Frame: Pre-dose, 1.5, 6 and 12 hours post-dose on Day 1; Pre-dose, 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 ]
    The AUC(0-12) is the area under the plasma concentration-time curve from time zero to 12 hours.


Secondary Outcome Measures:
  • Time to Influenza Viral Negativity [ Time Frame: Up to Day 28 ]
    Time to influenza viral negativity will be measured 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.

  • Viral Load Over Time [ Time Frame: Up to Day 28 ]
    Viral load over time will be measured by qRT-PCR and/or viral culture.

  • Rate of Decline in Viral Load [ Time Frame: Up to Day 28 ]
    Rate of decline in viral load during treatment as measured by qRT-PCR and/or viral culture.

  • Area Under the Plasma Concentration-Time Curve (AUC) of Viral Load [ Time Frame: Up to Day 28 ]
    The AUC of viral load as measured by qRT-PCR and/or viral culture.

  • Disease Status and Incidence of Complications Associated With Influenza [ Time Frame: Up to Day 28 ]
    Disease status and incidence of complications associated with influenza are: bacterial pneumonia (culture confirmed where possible), other bacterial superinfections, respiratory failure, pulmonary disease (example, asthma, chronic obstructive pulmonary disease [COPD]), cardiovascular and cerebrovascular disease (example, myocardial infarction, congestive heart failure [CHF], arrhythmia, stroke).

  • Change in Duration and Severity of Clinical Symptoms [ Time Frame: Up to Day 28 ]
    Change in duration and severity of clinical symptoms as measured by the Flu-iiQ (intensity and impact questionnaire) questionnaires.

  • Time to Improvement of Vital Signs [ Time Frame: Up to Day 28 ]
    Vital signs include systolic blood pressure [SBP], diastolic blood pressure [DBP], pulse rate, respiratory rate, and body temperature.

  • Time to Improvement of Respiratory Status [ Time Frame: Up to Day 28 ]
    Time to improvement of respiratory status is defined as normalization of blood oxygen saturation and respiration rate.

  • Emergence of Drug Resistance [ Time Frame: Up to Day 28 ]
    Emergence of drug resistance will be detected by genotype or phenotype.

  • Time to Return to Premorbid Functional Status [ Time Frame: Up to Day 28 ]
    Time to return to premorbid functional status will be evaluated.

  • Time to Hospital Discharge [ Time Frame: Up to Day 28 ]
    Time to hospital discharge in days will be analyzed using an accelerated failure time model (if the data provide an acceptable model fit) or alternatively a Cox proportional hazards model (in case the hazards are proportional).

  • Time to Significant Reduction in Influenza Symptom Severity [ Time Frame: Up to Day 28 ]
    Time to reduction in influenza symptom severity will be measured.

  • Percentage of Participants With a Significant Reduction to Mild or None for all Influenza Symptoms at Each Assessment [ Time Frame: Up to Day 28 ]
    Participants with a significant reduction to mild or none for all influenza symptoms at each assessment will be analysed.

  • Number of Participants with Adverse Events (AEs) and Serious AEs [ Time Frame: Screening up to follow-up (21 days after last dose administration) ]
    An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

  • Participants Improvement on Ordinal Scale [ Time Frame: Up to Day 28 ]
    The ordinal scale will be used to assess participant's status and consists of 6 categories or clinical states that are exhaustive, mutually exclusive, and ordered, where 1- Death, 2- Admitted to ICU or mechanically ventilated/ extracorporeal membrane oxygenation (ECMO), 3- Non-ICU plus supplemental oxygen, 4- Non-ICU plus no supplemental oxygen, 5- Not hospitalized, but unable to continue activity, 6- Not hospitalized and continues activities.


Enrollment: 102
Actual Study Start Date: December 11, 2015
Study Completion Date: March 15, 2017
Primary Completion Date: February 24, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: JNJ-63623872 plus Oseltamivir
Participants will be administered JNJ-63623872 600 milligram (mg) tablets and oseltamivir 75 mg capsules orally twice daily for 7 days.
Drug: JNJ-63623872
Participants will be administered JNJ-63623872 600 milligram (mg) tablets orally twice daily for 7 days.
Drug: Oseltamivir
Participants will be administered oseltamivir 75 mg capsules orally twice daily for 7 days.
Experimental: Placebo plus Oseltamivir
Participants will be administered placebo tablets and oseltamivir 75 mg capsules orally twice daily for 7 days.
Drug: Placebo
Participants will be administered placebo tablets orally twice daily for 7 days.
Drug: Oseltamivir
Participants will be administered oseltamivir 75 mg capsules orally twice daily for 7 days.

Detailed Description:
This is a randomized (study medication assigned to participants by chance), double-blind (neither the researchers nor the participants know what treatment the participant is receiving), placebo-controlled, multicenter (when more than one hospital or medical school team work on a medical research study) study to evaluate the effect of JNJ-63623872 in combination with oseltamivir in participants with influenza A infection. The study consists of 3 Phases: Screening visit (1 Day), participants who meet all eligibility criteria will be randomized in a 2:1 ratio to receive study drug in double-blind treatment Phase (7 Days) and follow up Phase (21 Days). The duration of participation in the study for each participant is approximately 28 Days. Primarily Pharmacokinetic parameters of JNJ-63623872 will be measured. Participants' safety will be monitored throughout the study.
  Eligibility

Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02532283

  Show 69 Study Locations
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
  More Information

Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT02532283     History of Changes
Other Study ID Numbers: CR107746
2015-003002-17 ( EudraCT Number )
63623872FLZ2002 ( Other Identifier: Janssen Research & Development, LLC )
Study First Received: August 21, 2015
Last Updated: June 22, 2017

Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Janssen Research & Development, LLC:
Influenza A virus
JNJ-63623872
Oseltamivir

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Antiviral Agents
Oseltamivir
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 26, 2017