The purpose of this study is to investigate how quickly and to what extent JNJ-64417184 is absorbed and eliminated from the body when it is given together with drugs that reduce the stomach acidity. The study also investigates how safe the new…
ID
Source
Brief title
Condition
- Respiratory tract infections
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- To evaluate the effect of multiple-dose administration of lansoprazole on the
single-dose PK of JNJ-64417184 in healthy adult participants
- To evaluate the effect of time-separated, multiple-dose administration of
famotidine on the single-dose PK of JNJ-64417184 in healthy adult participants
(optional).
Secondary outcome
- To explore the safety and tolerability of single-dose JNJ-64417184 when
administered alone and in combination with multiple-dose lansoprazole or
famotidine (optional) in healthy adult participants.
Background summary
JNJ-64417184 is a new compound that may potentially be used for the treatment
of acute lower respiratory tract infection caused by the respiratory syncytial
virus. The RS-virus is considered to be the most important virus that causes
lower respiratory tract infection and is a major cause of hospital admissions
and death in young children worldwide. JNJ-64417184 works by inhibiting the
genetic multiplication of the virus and thereby slows down the production of
new virus particles.
Lansoprazole and famotidine are drugs that reduce the release of acid into the
stomach. The drugs therefore reduce the acidity in the stomach. These types of
medications are frequently administered to RS-virus infected patients.
The results of this study will be used to provide dose recommendations for
coadministration of JNJ-64417184 with drugs that reduce the acidity of the
stomach.
Study objective
The purpose of this study is to investigate how quickly and to what extent
JNJ-64417184 is absorbed and eliminated from the body when it is given together
with drugs that reduce the stomach acidity. The study also investigates how
safe the new compound JNJ-64417184 is and how well it is tolerated in healthy
volunteers when it is administered alone or in combination with antacids.
Furthermore, the effect of the genetic information on the body*s response to
JNJ-64417184 will be investigated.
JNJ-64417184 has already been administered to humans before. It has also been
extensively tested in the laboratory and on animals.
In the first part of this study, JNJ-64417184 will be given with lansoprazole.
Lansoprazole is no new compound; it is already available on the market in
several dosages. In the second part, JNJ-64417184 will be given with
famotidine. Famotidine is also already available on the market in several
dosages.
Study design
The actual study will consist of up to 3 periods during which the volunteer
will stay in the research center for 7, 11, and 7 days (6, 10, and 6 nights).
On Day 1 of the first period at the latest, it will be determined whether the
volunteer start with 7 or 11 days. This will be determined by drawing lots. In
each period, the volunteers are expected at the research center at 11:00 h in
the morning on Day -1. The time of entry may be changed. If this happens the
volunteer will be informed about it in advance. There will be at least 7 days
between subsequent JNJ-64417184 intakes. Please refer to the table below to see
a general overview of the different treatments.
Treatment A:
Day Activity
-1 Entry in the research center
1 Intake of 400 mg JNJ-64417184
2 - 5 Stay in the research center
6 Leave the research center
Treatment B:
Day Activity
-1 Entry in the research center
1 - 4 Intake of 30 mg lansoprazole once per day
5 Intake of 30 mg lansoprazole
Intake of 400 mg JNJ-64417184, 2 hours after ingesting lansoprazole
6 - 9 Stay in the research center
10 Leave the research center
Treatment C:
Day Activity
-1 Entry in the research center
Intake of 40 mg famotidine, 12 hours prior to ingesting JNJ-64417184
1 Intake of 400 mg JNJ-64417184
Intake of 40 mg famotidine, 12 hours after ingesting JNJ-64417184
2-5 Stay in the research center
6 Leave the research center
Intervention
This study will consist of up to 3 periods. The volunteer will receive a
different treatment in each period.
The 3 treatments are:
- Treatment A: a single 400 mg dose of JNJ-64417184 on Day 1
- Treatment B: 30 mg lansoprazole once daily in the morning on Days 1 to 4, and
30 mg lansoprazole 2 hours before a single 400 mg JNJ 64417184 dose on the
morning of Day 5
- Treatment C: 40 mg famotidine 12 hours before and 12 hours after a single 400
mg dose of JNJ 64417184 on Day 1
It is not yet certain whether treatment C in Period 3 will continue. Whether
treatment C will be done depends on the results of treatment A and treatment B.
Study burden and risks
JNJ-64417184 is currently being evaluated in an ongoing study involving healthy
subjects. To date, 120 healthy volunteers have received a single dose of the
study drug up to 600 mg or multiple doses up to 900 mg for 7 or 14 days. Some
of those volunteers took a dummy drug (placebo) instead of the study drug.
Tested doses were safe and well tolerated. The following side effects have been
reported in the ongoing clinical trial with JNJ 64417184 at doses up to 600
mg:
• dizziness
• headache/migraines
• inflammation of the nasal passages
• upset stomach/heart burn
• back pain
• insomnia
• sleepiness
• elevated levels of lipase in the blood
It is not certain if these side effects are related to JNJ-64417184. All side
effects were mild or moderate in severity.
Lansoprazole
Lansoprazole may also cause side effects. The most frequent ones (observed in 1
to 10 in 100 people) are:
• Headache, dizziness
• Nausea, diarrhea, abdominal pain, constipation, vomiting, flatulence, dry
mouth or throat, benign stomach polyps
• Elevated liver enzyme values
• Hives, itching, skin rashes
• Fatigue
Famotidine
Famotidine may also cause side effects. The most frequent ones (observed in 1
to 10 in 100 people) are:
• Headache, dizziness
• Constipation, diarrhea
The study compound may also have side effects that are still unknown. In
addition to unknown side effect, there is a (small) chance that an allergic
reaction will occur. This can be caused by the study compound or the excipients.
Possible discomforts due to procedures
Drawing blood and/or insertion of the indwelling cannula may be painful or
cause some bruising.
In total, we will take up to 450 milliliters of blood from the volunteer. This
amount does not cause any problems in adults. To compare: a blood donation
involves 500 mL of blood being taken each time.
To make a heart tracing, electrodes will be pasted at specific locations on
your arms, chest and legs. Prolonged use of these electrodes can cause skin
irritation.
Fasting at least 10 hours could cause dizziness, headache, stomach discomfort,
or fainting.
A sample for the coronavirus test will be taken from the back of the nose and
throat using a swab. Taking the sample only takes a few seconds, but can cause
discomfort and can give an unpleasant feeling. Taking a sample from the back of
the throat may cause the volunteer to gag. When the sample is taken from the
back of the nose, the volunteer may experience a stinging sensation and the
eyes may become watery.
Turnhoutseweg 30
Beerse B-2340
BE
Turnhoutseweg 30
Beerse B-2340
BE
Listed location countries
Age
Inclusion criteria
1. Male or female, 18 to 54 years of age, extremes included, at screening.
2. Must have a body mass index between 18.0 and 30.0 kg/m2, extremes included,
and body weight not less than 50.0 kg at screening.
3. Healthy on the basis of physical examination, medical and surgical history,
and vital signs performed at screening. If there are abnormalities other than
those listed in Exclusion Criteria 2 and 3, the participant 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 participant's source documents and
initialed by the investigator.
4. Must have a normal 12-lead ECG (triplicate) at screening, including: normal
sinus rhythm (heart rate between 45 and 100 beats per minute, extremes
included); QT interval corrected for heart rate (QTc) according to Fridericia
(QTcF) <=450 ms for male participants and <=470 ms for female participants; QRS
interval <120 ms; PR interval <=200 ms. If the results of the ECG are outside
the normal ranges, the participant may be included only if the investigator
judges the deviations from normal ECG to be not clinically significant or to be
appropriate and reasonable for the population under study. This determination
must be recorded in the participant's source documents and initialed by the
investigator.
5. Must not use nicotine-containing substances including tobacco products (eg,
cigarettes, e-cigarettes, cigars, chewing tobacco, gum, or patch) for at least
3 months prior to screening.
For additional inclusion criteria, cross-refer to the protocol
Exclusion criteria
1. 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] formula),
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.
2. Past history of clinically significant cardiac arrhythmias (eg,
extrasystoli, tachycardia at rest), history of risk factors for Torsade de
Pointes syndrome (eg, hypokalemia, family history of long QT Syndrome).
3. Any evidence of clinically significant heart block or bundle branch block at
screening.
4. Current human immunodeficiency virus 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.
For additional exclusion criteria cross-refer to the protocol
Design
Recruitment
Medical products/devices used
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 | EUCTR2020-000380-23-NL |
| CCMO | NL73743.056.20 |