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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: JNJ-54135419

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Phase 1

Contacts and Locations

Study Locations

• Belgium
  • Antwerpen, Belgium, 2060
    • SGS Life Science Services

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Janssen Research & Development, LLC

Study record dates

Study Major Dates

• Study Start (Actual): February 18, 2020
• Primary Completion (Actual): August 11, 2020
• Study Completion (Actual): August 17, 2020

Study Registration Dates

• First Submitted: February 21, 2020
• First Submitted That Met QC Criteria: February 21, 2020
• First Posted (Actual): February 25, 2020

Study Record Updates

• Last Update Posted (Actual): September 16, 2021
• Last Update Submitted That Met QC Criteria: September 14, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Ketamine
• Other Study ID Numbers: CR108751; 54135419EDI1002 (Other Identifier: Janssen Research & Development, LLC); 2019-004129-25 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency.

As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No