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

NCT ID: NCT04282746

Last Updated: 2025-04-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-18
• Study Completion Date: 2020-08-17

Brief Summary

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.

Conditions

Healthy

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

JNJ-54135419

Intervention Type: DRUG

Single dose of JNJ-54135419 oral solution will be administered sublingually.

Interventions

JNJ-54135419

Single dose of JNJ-54135419 oral solution will be administered sublingually.

Intervention Type: DRUG

Other Intervention Names

(S)-ketamine

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

SGS Life Science Services

Antwerp, , Belgium

Countries

Belgium

Other Identifiers

54135419EDI1002

Identifier Type: OTHER

Identifier Source: secondary_id

2019-004129-25

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CR108751

Identifier Type: -

Identifier Source: org_study_id