A Study of Sublingually Administered (S)-Ketamine Oral Solution in Healthy Participants

Recruitment & Eligibility

Inclusion Criteria

Body mass index (BMI) between 20.0 and 28.0 kilogram per meter square kg/m^2 inclusive (BMI = weight/height^2) with a minimum weight of 60 kilogram (kg) and a maximum of 100 kg
Participant must be healthy based on clinical laboratory tests performed at screening. If the results of the serum chemistry panel, hematology or urinalysis are outside the normal reference ranges, retesting of an abnormal lab value that may lead to exclusion will be allowed once during the screening phase
Non-smoker (not smoked for 3 months prior to screening)
A woman must have a negative serum beta-human chorionic gonadotropin (beta-hCG) at screening and a negative urine pregnancy test prior to dosing on Day 1
A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for at least 1 month after the last study drug administration

Exclusion Criteria

Cardiac arrhythmias or other cardiac disease, hematological disease, hypertension, lipid abnormalities, respiratory disease, diabetes mellitus, renal or hepatic insufficiency, thyroid disease, Parkinson's disease, infection, glaucoma, epilepsy or any other illness that the Investigator considers should exclude the participant
Positive for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies or human immunodeficiency virus (HIV) antibodies at screening visit
Drinks, on average, more than 5 cups of tea/coffee/cocoa or 8 cans of cola per day
Clinically significant acute illness within 7 days prior to study drug administration
Donation of 1 or more units (approximately 450 milliliter [mL]) of blood or acute loss of an equivalent amount of blood within 90 days prior to study drug administration

Study & Design

Arm && Interventions

Group	Intervention	Description
JNJ-54135419	JNJ-54135419	Participants will receive a single oral dose of JNJ-54135419-AAA oral solution for sublingual administration in 1 of 3 serial dose escalating cohorts in fasted conditions.

Primary Outcome Measures

Name	Time	Method
Plasma Concentrations of (S)-ketamine	Predose, 1 minute (min), 3 min, 5 min, 10 min, 15 min, 30 min, 40 min, 1 hour (h), 1.5h, 2h, 3h, 4h, 6h, 8h, 12h and 24h postdose	Observed plasma concentrations of (S)-ketamine will be reported.
Plasma Concentrations of Nor-(S)-ketamine	Predose, 1 minute (min), 3 min, 5 min, 10 min, 15 min, 30 min, 40 min, 1 hour (h), 1.5h, 2h, 3h, 4h, 6h, 8h, 12h and 24h postdose	Observed plasma concentrations of nor-(S)-ketamine will be reported.

Secondary Outcome Measures

Name	Time	Method
Number of Participants with Vital Sign Abnormalities	Up to 4 Weeks	Number of participants with vital signs (heart rate \[HR\], systolic blood pressure \[SBP\], diastolic blood pressure \[DBP\]) abnormalities will be reported.
Number of Participants with Adverse Events (AEs)	Up to 4 Weeks	An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product does not necessarily have a causal relationship with the treatment.

Recruitment & Eligibility