The purpose of this study is to investigate how quickly and to what extent JNJ-64417184 and JNJ-53718678 are absorbed and eliminated from the body (this is called pharmacokinetics) when administered alone and when administered together. It will also…
ID
Source
Brief title
Condition
- Respiratory tract infections
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To evaluate the effect of single- and multiple-dose (once daily for 7 days)
oral JNJ-64417184 on the PK of single- and multiple-dose (once daily for 7
days) oral JNJ-53718678 when coadministered to healthy adult subjects under fed
conditions.
To evaluate the effect of single- and multiple-dose (once daily for 7 days)
oral JNJ-53718678 on the PK of single- and multiple-dose (once daily for 7
days) oral JNJ-64417184 when coadministered to healthy adult subjects under fed
conditions.
Secondary outcome
To evaluate the safety and tolerability of single- and multiple-dose (once
daily for 7 days) oral JNJ-64417184 and JNJ-53718678 when administered alone
and in combination in healthy adult subjects under fed conditions.
.
Background summary
JNJ-64417184 and JNJ-53718678 are new compounds that may eventually be used for
the treatment of infection with respiratory syncytial virus (RS-virus). Both
compounds are able to inhibit the RS-virus by different mechanisms of action.
JNJ 64417184 is able to inhibit the RS-virus by inhibiting the viral protein
production in the virus whereas JNJ-53718678 is able to inhibit the fusion of
RS-viruses with certain cells. A combination of the 2 compounds targeting 2
different mechanisms of action might be a more effective approach for treating
RS-virus infection than each compound alone.
Study objective
The purpose of this study is to investigate how quickly and to what extent
JNJ-64417184 and JNJ-53718678 are absorbed and eliminated from the body (this
is called pharmacokinetics) when administered alone and when administered
together. It will also be investigated how safe the new compounds JNJ-64417184
and JNJ-53718678 are and how well they are tolerated when they are administered
alone or as a combination to healthy volunteers.
Study design
The actual study will consist of 3 treatment periods during which the subjects
will stay in the research center for 9 days (8 nights).
In each treatment period, Day 1 is the first day of administration of the study
compound. In each treatment period, subjects are expected at the research
center at 14:00 h in the afternoon prior to the day of first administration of
the study compound. In each treatment period, subjects will leave the research
center on Day 8.
Intervention
The study consists of 3 treatment periods. In each treatment period, subjects
will receive either JNJ-6441784 or JNJ 53718678 alone, or a combination of JNJ
64417184 and JNJ 53718678, once daily for 7 consecutive days. There will be 6
different treatment orders as explained in the table below. The order in which
subjects will receive these treatments will be determined by chance.
JNJ 64417184 will be given as tablets and JNJ 53718678 will be given as an oral
suspension (a drink). Thereafter subjects will have to drink approximately 240
milliliter (mL) of water. When JNJ-64417184 and JNJ-53718678 are
coadministered, then intake of JNJ-64417184 will be first followed by
JNJ-53718678. There will be a maximum of 5 minutes between both
administrations.
Study burden and risks
JNJ-64417184
JNJ-64417184 is being studied in one other ongoing placebo-controlled clinical
study, in which this compound or placebo has been administered to 80 healthy
adult subjects as single and multiple doses. The highest dose level tested thus
far is 900 mg. All doses were well tolerated. The most commonly reported side
effects (reported at least 2 times) were headache, dizziness, vomiting,
pruritus (itch) and nasopharyngitis that were all mild or moderate. Two side
effects were considered related to the study compound, these were somnolence
and dyspepsia (stomach upset).
JNJ-53718678
JNJ-53718678 has been studied in 5 completed clinical studies and is being
studied in 3 ongoing clinical studies. A total of 234 subject received at least
one dose of JNJ-53718678. Also children which were hospitalized due to
naturally acquired RS-virus infection, have received JNJ-53718678. Overall,
treatment with JNJ-53718678 was generally safe and well tolerated. The most
commonly reported side effects were diarrhea and dysgeusia. All side effects
were mild or moderate.
The study compounds may also have side effects that are still unknown.
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 about 500mL of blood. This amount does not cause any
problems in adults.
To make a heart tracing, electrodes will be pasted at specific locations on the
arms, chest and legs. Prolonged use of these electrodes can cause skin
irritation.
Turnhoutseweg 30
Beerse B-2340
BE
Turnhoutseweg 30
Beerse B-2340
BE
Listed location countries
Age
Inclusion criteria
1. Male or female, between 18 and 55 years of age, extremes included, at
screening.
2. Body mass index (BMI; weight [kg]/height2 [m]2) between 18.0 and 30.0 kg/m2,
extremes included, and body weight not less than 50 kg at screening.
3. Healthy on the basis of physical examination (including skin examination),
medical and surgical history, and vital signs (systolic blood pressure [SBP],
diastolic blood pressure [DBP], and pulse rate [after the subject is supine for
at least 5 minutes], respiratory rate, and oral body temperature) performed at
screening. If there are abnormalities (not applicable for the parameters listed
in inclusion criterion 5 [for blood pressure]), the subject may be included
only if the investigator judges the abnormalities to be not clinically
significant. This determination must be recorded in the subject's source
documents and initialed by the investigator.
4. Healthy on the basis of clinical laboratory tests performed at screening. If
the results of the hematology, biochemistry, blood coagulation, or urinalysis
are outside the normal reference ranges (not applicable for the parameters
listed in exclusion criteria 1 and 2 [for laboratory parameters]), the subject
may be included only if the investigator judges the abnormalities or deviations
from normal to be not clinically significant. This determination must be
recorded in the subject's source documents and initialed by the investigator.
5. Blood pressure (after the subject is supine for 5 minutes) between 90 and
140 mmHg systolic, extremes included, and no higher than 90 mmHg diastolic at
screening.
Further criteria apply
Exclusion criteria
1. History of, or current clinically significant medical illness including (but
not limited to) cardiac arrhythmias or other cardiac disease, hematologic
disease, coagulation disorders (including any abnormal bleeding or blood
dyscrasias), lipid abnormalities, significant pulmonary disease, including
bronchospastic respiratory disease, diabetes mellitus, hepatic or renal
insufficiency (calculated creatinine clearance/estimated glomerular filtration
rate [eGFR] <60 mL/min at screening, calculated by the Modification of Diet in
Renal Disease [MDRD] formula30), thyroid disease, neurologic or psychiatric
disease, infection, or any other illness that the investigator considers should
exclude the subject or that could interfere with the interpretation of the
study results.
2. Any laboratory abnormality >=grade 1 (as defined by the Division of Acquired
Immune Deficiency Syndrome [DAIDS] Table for Grading the Severity of Adult and
Pediatric Adverse Events)9, considered to be clinically significant by the
investigator at screening.
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. Any evidence of heart block or bundle branch block at screening.
5. History of human immunodeficiency virus type 1 (HIV-1) or HIV-2 infection,
or tests positive for HIV-1 or -2 at screening.
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 | EUCTR2019-002695-13-NL |
| CCMO | NL71262.056.19 |