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

Study Overview
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Brief Summary
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The purpose of this study is to characterize the plasma pharmacokinetic (PK) profile following the single ascending dose (SAD) levels of an (S)-ketamine oral solution for sublingual administration in healthy participants.

Official Title
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An Open-label, Single Ascending Dose Study to Investigate the Safety, Tolerability and Pharmacokinetics of Sublingually Administered (S)-Ketamine Oral Solution in Healthy Participants

Conditions
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Healthy

Intervention / Treatment
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* Drug: JNJ-54135419


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: JNJ-54135419<br>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. | Drug: JNJ-54135419<br>* Single dose of JNJ-54135419 oral solution will be administered sublingually.<br>* Other names: (S)-ketamine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma Concentrations of (S)-ketamine | Observed plasma concentrations of (S)-ketamine will be reported. | 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 | 
| Plasma Concentrations of Nor-(S)-ketamine | Observed plasma concentrations of nor-(S)-ketamine will be reported. | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Vital Sign Abnormalities | Number of participants with vital signs (heart rate [HR], systolic blood pressure [SBP], diastolic blood pressure [DBP]) abnormalities will be reported. | Up to 4 Weeks | 
| Number of Participants with Adverse Events (AEs) | 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. | Up to 4 Weeks |