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
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
3 other identifiers
interventional
102
15 countries
68
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Dec 2015
Shorter than P25 for phase_2
68 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 21, 2015
CompletedFirst Posted
Study publicly available on registry
August 25, 2015
CompletedStudy Start
First participant enrolled
December 11, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 24, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
March 15, 2017
CompletedResults Posted
Study results publicly available
March 27, 2020
CompletedMarch 27, 2020
March 1, 2020
1.2 years
August 21, 2015
February 6, 2020
March 26, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Maximum Observed Plasma Concentration (Cmax) of Pimodivir
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).
Pre-dose, 1, 2, 4, 6, 8, 10 and 12 hours post-dose on Day 3
Minimum Observed Plasma Concentration (Cmin) of Pimodivir
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).
Pre-dose, 1, 2, 4, 6, 8, 10 and 12 hours post-dose on Day 3
Area Under the Plasma Concentration-time Curve From Time of Administration to 12 Hours After Dosing (AUC [0-12]) of Pimodivir
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).
Pre-dose, 1, 2, 4, 6, 8, 10 and 12 hours post-dose on Day 3
Secondary Outcomes (16)
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious AEs (TESAEs)
Up to 28 Days
Time to Influenza A Viral Negativity
Up to 14 Days
Influenza Viral Load Over Time
Baseline, Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14
Rate of Decline in Viral Load
Up to Day 7
Area Under the Plasma Concentration-time Curve (AUC) of Viral Load
Baseline up to Day 8
- +11 more secondary outcomes
Study Arms (2)
JNJ-63623872 plus Oseltamivir
EXPERIMENTALParticipants will be administered JNJ-63623872 600 milligram (mg) tablets and oseltamivir 75 mg capsules orally twice daily for 7 days.
Placebo plus Oseltamivir
EXPERIMENTALParticipants will be administered placebo tablets and oseltamivir 75 mg capsules orally twice daily for 7 days.
Interventions
Participants will be administered JNJ-63623872 600 milligram (mg) tablets orally twice daily for 7 days.
Participants will be administered placebo tablets orally twice daily for 7 days.
Participants will be administered oseltamivir 75 mg capsules orally twice daily for 7 days.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (68)
Unknown Facility
Fresno, California, United States
Unknown Facility
Long Beach, California, United States
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Stanford, California, United States
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Atlantis, Florida, United States
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Miami, Florida, United States
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Chicago, Illinois, United States
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Detroit, Michigan, United States
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Royal Oak, Michigan, United States
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Troy, Michigan, United States
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Minneapolis, Minnesota, United States
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St Louis, Missouri, United States
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Teaneck, New Jersey, United States
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Winston-Salem, North Carolina, United States
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Houston, Texas, United States
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Cairns, Australia
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South Brisbane, Australia
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Westmead, Australia
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Aalst, Belgium
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Brussels, Belgium
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Leuven, Belgium
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Passo Fundo, Brazil
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Porto Alegre, Brazil
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São Paulo, Brazil
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Hamilton, Ontario, Canada
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Québec, Quebec, Canada
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Dijon, France
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Grenoble, France
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Limoges, France
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Lyon, France
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Nantes, France
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Paris, France
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Poitiers, France
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Rennes, France
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Saint-Priest-en-Jarez, France
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Tours, France
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Donaustauf, Germany
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Jena, Germany
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Hong Kong, Hong Kong
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Kota Bharu, Malaysia
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Kuala, Malaysia
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Kuala Lumpur, Malaysia
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Kuching, Malaysia
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Malacca, Malaysia
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Miri, Malaysia
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Sungai Buloh, Malaysia
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Taiping, Malaysia
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Rotterdam, Netherlands
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Utrecht, Netherlands
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Zutphen, Netherlands
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Hamilton, New Zealand
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Singapore, Singapore
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Alicante, Spain
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Barcelona, Spain
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Bizkaia, Spain
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Elche, Spain
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Granada, Spain
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Madrid, Spain
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Mataró, Spain
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San Sebastián, Spain
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Vigo, Spain
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Malmo, Sweden
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Umeå, Sweden
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Uppsala, Sweden
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Ankara, Turkey (Türkiye)
Unknown Facility
Eskişehir, Turkey (Türkiye)
Unknown Facility
Istanbul, Turkey (Türkiye)
Unknown Facility
Izmir, Turkey (Türkiye)
Unknown Facility
Trabzon, Turkey (Türkiye)
Related Publications (1)
O'Neil B, Ison MG, Hallouin-Bernard MC, Nilsson AC, Torres A, Wilburn JM, van Duijnhoven W, Van Dromme I, Anderson D, Deleu S, Kosoglou T, Vingerhoets J, Rossenu S, Leopold L. A Phase 2 Study of Pimodivir (JNJ-63623872) in Combination With Oseltamivir in Elderly and Nonelderly Adults Hospitalized With Influenza A Infection: OPAL Study. J Infect Dis. 2022 Aug 12;226(1):109-118. doi: 10.1093/infdis/jiaa376.
PMID: 32604406DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Senior Director
- Organization
- Janssen Research & Development, LLC
Study Officials
- STUDY DIRECTOR
Janssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 21, 2015
First Posted
August 25, 2015
Study Start
December 11, 2015
Primary Completion
February 24, 2017
Study Completion
March 15, 2017
Last Updated
March 27, 2020
Results First Posted
March 27, 2020
Record last verified: 2020-03