The purpose of this study is to investigate how quickly and to what extent JNJ-64417184 is absorbed, distributed, metabolized and eliminated from the body. The pharmacokinetics of JNJ-64417184 when it is administered in the morning following the…
ID
Source
Brief title
Condition
- Respiratory tract infections
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
• To evaluate the effect of 45 different types of food conditions on the single
dose PK of the JNJ184JNJ-64417184 tablet formulation administered orally, using
the PK after a high fat meal as a reference, in healthy subjects.
Secondary outcome
• To determine the PK parameters of JNJ-64417184 after a single dose.
• To assess the safety and tolerability of JNJ-64417184 after a single dose
when administered to healthy adult subjects.
Background summary
JNJ-64417184 is a new compound that may potentially be used for the treatment
of infections with the respiratory syncytial virus (RS-virus). The RS-virus is
a common virus that causes common colds. However, especially in very young
children an infection with the RS-virus can result in lower respiratory tract
infections and can cause very serious pneumonia. Also, elderly persons and
persons with underlying chronic diseases or diminished immunity are at risk of
developing serious illness. JNJ 64417184 is able to inhibit the RS-virus by
inhibiting the viral protein production.
Study objective
The purpose of this study is to investigate how quickly and to what extent
JNJ-64417184 is absorbed, distributed, metabolized and eliminated from the
body. The pharmacokinetics of JNJ-64417184 when it is administered in the
morning following the intake of a high-fat breakfast will be compared to the
pharmacokinetics of JNJ-64417184 when it is administered in the morning:
• following the intake of a standard breakfast
• the intake of a low-fat breakfast
• the intake of a balanced nutrition drink (Ensure* Original)
• under fasted conditions (no eating and drinking except water)
Further, it will be investigated how safe JNJ-64417184 is and how well it is
tolerated.
JNJ 64417184 has been administered to humans before.
This study will be performed in approximately 20 healthy male or female
volunteers.
Study design
The actual study will consist of 4 periods during each of which the volunteers
will stay in the research center for 7 days (6 nights). In each treatment
period, Day 1 is the day of administration of the study compound. In each
treatment period, they are expected at the research center at 14:00 h in the
afternoon prior to the day of administration of the study compound. In each
treatment period, they will leave the research center on Day 6.
There will be at least 7 days between administration of the study compound in
each period.
Intervention
The study consists of 4 treatment periods. In each treatment period, the
volunteers will receive a single dose of 300 milligrams (mg) JNJ-6441784. The
meal regimen prior to administration of JNJ-6441784 is different in each
period. They will receive the high-fat breakfast on Day 1 in one of the 4
periods and they will undergo 3 of the other 4 meal regimens (standard
breakfast, low-fat breakfast, nutrition drink or fasted conditions) on Day 1 in
the other 3 periods. There will be 16 different meal regimen orders in this
study and the volunteer will be assigned to one of these orders.
The different breakfast types must be started exactly on time in the morning
and must be finished within 20 minutes. In each period, the entire breakfast
must be consumed.
JNJ 64417184 will be given as an oral tablet (1 tablet of 300 mg) with 240
milliliters (mL) of water without chewing the tablet. In case the nutrition
drink is the breakfast type, the tablet may be taken with 240 mL of water, but
it may also be taken without water.
The intake of water is not allowed from approximately 1 hour before until
approximately 1 hour after intake of the study compound (except for the water
used for intake of the study compound and for breakfast, if applicable).
Following administration of JNJ 64417184, the volunteers will fast for a period
of 4 hours, until scheduled lunch.
One of the investigators will inspect the hands and mouth after the study
compound intake to see if you have swallowed the study compound.
Study burden and risks
Drawing blood and/or insertion of the indwelling cannula (tube in an arm vein)
may cause lightheadedness, pain, bruising, and bleeding at the site of needle
puncture, inflammation of the vein, and sometimes infection. On Day 1 of each
period, blood will be sampled very frequently up to 24 hours after
administration of the study compound to determine the course of the
concentration of JNJ-64417184 in the blood over time.
In total, we will take maximally 500 mL of blood.
To make a heart tracing, electrodes (small, plastic patches) will be pasted at
specific locations on the arms, chest and legs. Prolonged use of these
electrodes can cause skin irritation (rash and itching).
Fasting at least 10 hours could cause dizziness, headache, stomach discomfort,
or fainting.
The high-fat breakfast is a big breakfast consisting of 2 fried eggs, fried
potatoes, and bacon among other things. the volunteers must consume the
breakfast entirely. Particularly for small eaters, it can be difficult to
consume the entire breakfast.
Turnhoutseweg 30
Beerse B-2340
BE
Turnhoutseweg 30
Beerse B-2340
BE
Listed location countries
Age
Inclusion criteria
1. Male or female, 18 to 55 years of age, extremes included, at screening.
2. During the study (from the day of first study drug intake onwards) and for a
minimum of 1 spermatogenesis cycle (defined as approximately 90 days) after the
last study drug intake, a male subject must agree:
• To wear a condom when engaging in any activity that allows for passage of
ejaculate to another person (male subject should also be advised of the benefit
for a female partner to use a highly effective method of contraception as
condom may break or leak);
• Not to donate sperm for the purpose of reproduction.
Contraceptive use should be consistent with local regulations regarding the use
of contraceptive methods for subjects participating in clinical studies.
3. Female subjects must be of non-childbearing potential defined as:
• Postmenopausal
A postmenopausal state is defined as no menses for >12 months without an
alternative medical explanation. A high follicle stimulating hormone (FSH)
level (>40 IU/L or mIU/mL) in the postmenopausal range may be used to confirm a
postmenopausal state in women not using hormonal contraception or hormone
replacement therapy. In the absence of >12 months of amenorrhea, 2 FSH
measurements have to be available, measured at least 3 months apart, OR
• Permanently sterile
Permanent sterilization methods include hysterectomy, bilateral salpingectomy,
bilateral tubal occlusion/ligation procedures, and bilateral oophorectomy.
4. Must have a body mass index (BMI; weight [kg]/height2 [m2]) between 18.0 and
30.0 kg/m2, extremes included, and body weight not less than 50.0 kg at
screening.
5. Healthy on the basis of physical examination, medical and surgical history,
and vital signs performed at screening. If there are abnormalities, the subject
may be included only if the investigator judges the abnormalities to be not
clinically significant or to be appropriate and reasonable for the population
under study. This determination must be recorded in the subject's source
documents and initialed by the investigator.
Further Criteria apply.
Exclusion criteria
1. Any evidence of heart block or bundle branch block at screening.
2. History of liver or renal dysfunction (calculated creatinine
clearance/estimated glomerular filtration rate (eGFR) <60 mL/min at screening,
calculated by the Modification of Diet in Renal Disease [MDRD] formula28),
significant cardiac, vascular, pulmonary, gastrointestinal (such as significant
diarrhea, gastric stasis, or constipation that in the investigator*s opinion
could influence drug absorption or bioavailability), endocrine, neurologic,
hematologic, rheumatologic, psychiatric, neoplastic, or metabolic disturbances.
3. Past history of cardiac arrhythmias (eg, extrasystoli, tachycardia at rest),
history of risk factors for Torsade de Pointes syndrome (eg, hypokalemia,
family history of long QT Syndrome).
4. Current HIV-type 1 (HIV-1) or HIV-2 infection (confirmed by antibodies) at
screening.
5. History of hepatitis A, B, or C infection, or current hepatitis A infection
(confirmed by hepatitis A antibody immunoglobulin M [IgM]), or HBV infection
(confirmed by hepatitis B surface antigen), or HCV infection (confirmed by HCV
antibody) at screening.
Further criteria apply.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2019-003469-17-NL |
| CCMO | NL71356.056.19 |