Primary- To investigate the safety and tolerability of JNJ-55363932 after single oral dose administration(ascending dose levels) in healthy participants- To characterize the PK of JNJ-55363932 in plasma, cerebrospinal fluid (CSF) and urine…
ID
Source
Brief title
Condition
- Psychiatric disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Clinical labs (chemistry, hematology, urinalysis, coagulation [only Part 2])
- Adverse events (AE)
- (Holter) ECG and telemetry
Plasma, CSF (only Part 2), and urine concentrations (only Parts 1 and 3) of
JNJ-55363932 and when feasible, potential metabolites and plasma protein
binding
Secondary outcome
As assessed by NeuroCart parameters and resting state
phamacoelectroencephalogram
(phEEG)
Background summary
The purpose of this study is to investigate the safety and tolerability of
JNJ-55363932 after single oral dose administration (ascending dose levels) in
healthy participants and to characterize the pharmacokinetics (PK) of
JNJ-55363932 in plasma, cerebrospinal fluid (CSF) and urine after single oral
dose administration in healthy participants.
Study objective
Primary
- To investigate the safety and tolerability of JNJ-55363932 after single oral
dose administration
(ascending dose levels) in healthy participants
- To characterize the PK of JNJ-55363932 in plasma, cerebrospinal fluid (CSF)
and urine after
single oral dose administration in healthy participants
Study design
First-in-human, 3-part, randomized, placebo-controlled, double-blind, single
ascending dose (SAD) study in healthy participants.
Intervention
JNJ-55363932
Study burden and risks
There are no reproductive or developmental toxicology data yet available for
JNJ-55363932 and
no studies have examined the effects of JNJ-55363932 in pregnancy. Therefore,
only young
healthy male participants will be administered study intervention. This will
also reduce variability
in PK, and possibly PD, results. In Part 2 only, healthy middle-aged and
elderly WONCBP and
male participants aged 40-75 years may be included. There is evidence showing
that middle and
elderly individuals have lower rates of post-lumbar puncture headache compared
to younger
individuals.
JNJ-55363932 was evaluated in toxicity studies in preclinical animal species.
Increases in blood pressure
and changes in HR were observed. To mitigate this risk in this study, blood
pressure and HR, will
be monitored frequently for 96 hours. Thresholds will be set to alert the site
staff of significant
increases (or decreases). These data will be reviewed at the Data Visualization
(DV) meetings to
evaluate if protocol stopping criteria have been met.
This study will be performed in healthy participants who will receive no
benefit from participation
in the study, except for financial compensation for the time and inconveniences
that may arise from
participation in the study. However, the results of the investigation of
JNJ-55363932 may help
future patients.
Taking into account the measures taken to minimize risk to participants of this
study, the potential
risks identified in association with JNJ-55363932 are justified by the
anticipated benefits that may
be afforded to participants with psychiatric disorders.
. Turnhoutseweg 30
Beerse 2340
BE
. Turnhoutseweg 30
Beerse 2340
BE
Listed location countries
Age
Inclusion criteria
- Healthy based on physical examination, medical history, vital signs, and
12-lead electrocardiogram (ECG) performed at screening and admission to the
clinical unit
- In Part 2, a woman must not be of childbearing potential
- Participant has a body mass index (BMI) between 18 and 30 kilogram per meter
square (kg/m^2) inclusive
Exclusion criteria
- History of or current significant medical illness including (but not limited
to) cardiac arrhythmias or other cardiac disease, hypertension, hematological
disease, lipid abnormalities, bronchospastic respiratory disease, diabetes
mellitus, renal or hepatic insufficiency, thyroid disease, Parkinson*s disease,
infection, or any other illness that the investigator considers should exclude
the participant
- Has had a clinically significant acute illness within 14 days prior to study
intervention administration
- Has had major surgery, (for example, requiring general anesthesia) within 8
weeks before screening, or will not have fully recovered from surgery, or has
surgery planned during the time the participant is expected to participate in
the study or within 4 weeks after the last dose of study intervention
administration
- History of malignancy within 5 years before screening (exceptions are
squamous and basal cell carcinomas of the skin, or malignancy that in the
opinion of the investigator, with written concurrence with the safety
responsible physician, is considered cured with minimal risk of recurrence)
- Has acute symptoms of coronavirus disease 19 (COVID-19) infection or sequelae
at Day -1 or has had a positive severe acute respiratory syndrome coronavirus 2
(SARS-CoV-2) test after admittance to the clinical unit or at any of the repeat
tests
- For part 2 only: Has a significant coagulation abnormality (for example,
hemophilia, platelet counts less than the lower limit of normal or clinically
significant elevation in prothrombin time [PT] or activated partial
thromboplastin time [aPTT] at screening) or has a medical condition requiring
treatment with an anticoagulant (for example, warfarin) or with two or more
antiplatelet agents. Platelet counts between 125,000 and 150,000/microliter are
permissible if the investigator confirms there is no evidence of current
bleeding diathesis or coagulopathy, and having a contraindication for spinal
puncture
- Has a diagnosis or suspicions of any sleep disorder in the last 6 months or
current complaints of sleep disturbance, irregular sleep schedule or shift
work; habitual daytime naps; travel across 3 different time zones in the last 2
weeks or daytime symptoms attributable to unsatisfactory sleep
- Has undergone major lifestyle changes in the previous 6 months: significant
weight loss greater than (>) 5 kg or started a specific diet which could
potentially result in weight loss
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 | EUCTR2021-003959-41-NL |
| CCMO | NL79810.056.21 |