Study to Investigate Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-61393215 in Healthy Participants
- Conditions
- Panic/anxiety disorders
- Registration Number
- NL-OMON24181
- Lead Sponsor
- Janssen-Cilag International NV
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 80
Participants must have a body mass index (BMI) between 18 and 30 kilogram per meter square kg/m^2, inclusive (BMI = weight/height^2)
-Participant must be healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at Screening and admission to the clinical unit. Minor abnormalities in ECG, which are not considered to be of clinical significance by the investigator, are acceptable. The
presence of Left Bundle Branch Block (LBBB), Atrioventricular (AV) Block (second degree or higher), or a permanent pacemaker or implantable cardioverter defibrillator [ICD] will lead to exclusion
-Participant has a history of or current liver or renal insufficiency; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic (including coagulation disorders), rheumatologic, psychiatric, or metabolic disturbances, any inflammatory illness or any other illness. Minor deviations, which are not considered to be of clinical significance to both the investigator and to the Janssen Safety Responsible Physician, are acceptable
-Participant has estimated glomerular filtration rate (eGFR) less than (<) 60 milliliters per minute per
1.73 meter square (mL/min/1.73m^2) at Screening
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method -To Investigate the Safety and Tolerability of JNJ-61393215 Versus Placebo After Single Oral Dose Administration Under Fasted A22(Ascending Dose Levels) and fed Condition<br /><br>-To Characterize the Pharmacokinetics of JNJ-61393125 in Plasma, Cerebrospinal Fluid (CSF) and Urine After Single Oral Dose Administration<br /><br>-To Investigate the Effect of Food (High Fat/High Calorie) on the Pharmacokinetics of JNJ-61393215 following Single Oral Dose Administration<br /><br>-To Investigate the Safety and Tolerability of JNJ-61393215 Versus Placebo After 1 day of Twice a day Dosing<br /><br>-To Characterize the Pharmacokinetics of JNJ-61393215 in Plasma After 1 day of Twice a day Dosing
- Secondary Outcome Measures
Name Time Method -To Characterize the Effect of JNJ-61393215 on Alertness/Sedation and Cognition<br>