psychiatric disorders
Conditions
Interventions
JNJ-55363932
Sponsors
Janssen-Cilag
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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 outcomes
Primary
| Measure | Time frame |
|---|---|
| - 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
| Measure | Time frame |
|---|---|
| As assessed by NeuroCart parameters and resting state phamacoelectroencephalogram (phEEG) | — |
Countries
Netherlands
Outcome results
None listed