Study to Investigate Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-61393215 in Healthy Participants

Authors
Category Primary study
Registry of TrialsNetherlands Trial Register
Year 2016
INTERVENTION: ‐JNJ‐61393215: JNJ‐61393215 will be administered as an oral suspension. ‐Placebo: Matching placebo will be administered. CONDITION: Panic disorder, Anxiety disorders ; ; PRIMARY OUTCOME: ‐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; ; ‐To Characterize the Pharmacokinetics of JNJ‐61393125 in Plasma, Cerebrospinal Fluid (CSF) and Urine After Single Oral Dose Administration; ; ‐To Investigate the Effect of Food (High Fat/High Calorie) on the Pharmacokinetics of JNJ‐61393215 following Single Oral Dose Administration; ; ‐To Investigate the Safety and Tolerability of JNJ‐61393215 Versus Placebo After 1 day of Twice a day Dosing; ; ‐To Characterize the Pharmacokinetics of JNJ‐61393215 in Plasma After 1 day of Twice a day Dosing SECONDARY OUTCOME: ‐To Characterize the Effect of JNJ‐61393215 on Alertness/Sedation and Cognition ; INCLUSION CRITERIA: ‐ 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 ‐Participants must be healthy on the basis of clinical laboratory tests performed at screening. If the results of the serum chemistry panel, hematology or urinalysis are outside the normal reference ranges, the subject may be included only if the investigator judges the abnormalities to be not clinically
Epistemonikos ID: d3dd8a5a597262e2e7720d1b5cacd20df4c2a4da
First added on: Aug 24, 2024