A phase 1, open-label study to characterize the absorption, metabolism and excretion of
14C-JNJ-63623872 after a single dose in healthy male subjects

JNJ-63623872 is a new investigational compound that may eventually be used for
the treatment of influenza A. Influenza is an infectious disease, which infects
the respiratory tract, caused by the influenza virus, a family of RNA viruses
that infects also humans. JNJ-63623872 inhibits the reproduction of the
influenza A virus in the human body by stopping the action of the virus
polymerase, a protein that is responsible of the replication of the virus in
the body cells.
JNJ-63623872 is not registered as a drug but has been given to humans before in
several previous clinical studies.

The purpose of the study is to investigate how quickly and to what extent
JNJ-63623872 is absorbed, distributed, metabolized (broken down) and eliminated
from the body (this is called pharmacokinetics). The compound to be
administered will be labeled with 14-Carbon (14C) and is thus radioactive (also
called radiolabeled). This enables the investigator to trace the compound in
blood, urine, feces, saliva and nasal mucus. The safety and tolerability of the
compound will also be evaluated.

The actual study will consist of 1 period during which you will stay in the
clinical research center in Zuidlaren for a minimum of 9 days (8 nights) and a
maximum of 15 Days (14 nights).

On Day 1 the volunteer will receive the study compound in the form of three
capsules after an overnight fast (at least 10 hours) with 240 milliliters of
noncarbonated water, which the volunteer will have to drink entirely.

The volunteer will receive a single 600 mg dose of JNJ-63623872 in the form of
three capsules (200 mg per capsule).

JNJ-63623872 has been tested carefully in laboratory animals (mice, rats, dogs
and monkeys) and it is considered generally safe and well tolerated in animals.
The dose that we intend to give you is lower than the doses used in the animal
studies.
JNJ-63623872 has been studied in single and multiple doses in healthy subjects,
and in multiple doses in subjects infected artificially with influenza A.
JNJ-63623872 was generally safe and well tolerated. Approximately 228 subjects
have been exposed to JNJ-63623872; 64 subjects have received a single dose of
JNJ-63623872 (50 to 1600 mg) and 164 subjects have received multiple doses of
JNJ-63623872 (up to 600 mg twice daily and up to 10 days of dosing). The
adverse effects that occurred in subjects treated with JNJ-63623872 were
reversible (disappeared on their own) and the majority of adverse effects were
mild or moderate in severity.

Based on data collected in clinical trials conducted to date, the most common
adverse effects are:

- Very common occurring in more than 1 in 10 subjects: Headache and diarrhea
were seen at this frequency in healthy subjects and were considered by the
investigator to be possibly related to study drug.
- In some subjects who were artificially infected with influenza A virus, brief
mild to moderate elevations of liver enzymes and decreased blood phosphorus
with no associated clinical symptoms were seen after study drug administration.
These effects resolved without any treatment.

Registration of adverse effects: During the entire study all adverse effects
you report will be documented.

Blood sampling, indwelling cannula: During this study less than 500 milliliters
of blood will be drawn. An indwelling cannula will be used regularly to sample
blood on Day 1. Remaining blood samples during pre-study screening, on Day -1,
on Day 2 to Day 6, at discharge, and the post-study screening visit will be
drawn by direct puncture of the vein. The blood samples are drawn to measure
the amount of JNJ-63623872 and total radioactivity in your blood. Also certain
blood samples are used for general checks of your health. At pre-study
screening a check for hepatitis A, B and C and HIV (= AIDS-test) will be done
on the blood sample.

Collection of urine and feces: Urine and feces will be collected from Day -1
onwards until Day 8 (after administration of JNJ-63623872) with a possible
extension to Day 14. The urine and feces samples will be used to measure the
amount of total radioactivity. Also certain urine samples are used for general
checks of the volunteers health. At pre-study screening and on Day -1 a check
for drugs of abuse and alcohol will be done on the urine sample.

Vital signs: Blood pressure, pulse rate, respiratory rate and body temperature
will be measured regularly during the pre-study screening day, on Day 1, at
discharge and during the post-study screening. This will occur in the supine
and standing position.

Heart trace (ECG): ECGs will be made regularly: specifically during the
pre-study screening, on Day 1, at discharge and during the post-study
screening.

Physical examination: A physical examination will be done during pre-study
screening, on Day -1, at discharge and during post-study screening. Your body
weight and height will also be measured (height only at pre-study screening).

Saliva sampling: On Day 1, for a total amount of 6 times, saliva will be
sampled. For this purpose the volunteer will be asked to spit in a collection
tube until a pre-defined amount of saliva is collected. In the saliva samples
the amount of JNJ-63623872 and total radioactivity will be determined.

Nasal Lavage: On Day -1 and on Day 1 the volunteer will undergo a nasal lavage
(thus for a total of 2 times). The volunteers nose, both nostrils, will be
rinsed with saline by using a syringe. After rinsing, the saline solution with
nasal mucus included, will be collected and the amount of radioactivity will be
determined. This procedure will be executed by the study staff.