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



Status:Completed
Conditions:Influenza
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - 85
Updated:2/11/2018
Start Date:December 11, 2015
End Date:March 15, 2017

Use our guide to learn which trials are right for you!

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

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.

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.

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
We found this trial at
15
sites
?
mi
from
Chicago, IL
Click here to add this to my saved trials
?
mi
from
Atlantis, FL
Click here to add this to my saved trials
?
mi
from
Cairns,
Click here to add this to my saved trials
?
mi
from
Detroit, MI
Click here to add this to my saved trials
?
mi
from
Fresno, CA
Click here to add this to my saved trials
?
mi
from
Houston, TX
Click here to add this to my saved trials
?
mi
from
Long Beach, CA
Click here to add this to my saved trials
?
mi
from
Miami, FL
Click here to add this to my saved trials
?
mi
from
Minneapolis, MN
Click here to add this to my saved trials
?
mi
from
Royal Oak, MI
Click here to add this to my saved trials
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
?
mi
from
Stanford, CA
Click here to add this to my saved trials
?
mi
from
Teaneck, NJ
Click here to add this to my saved trials
?
mi
from
Troy, MI
Click here to add this to my saved trials
?
mi
from
Winston-Salem, NC
Click here to add this to my saved trials