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JNJ-54135419

Phase 1

Healthy | Small molecule | Other |Johnson & Johnson|Last Updated: Apr 27, 2025

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment17

FDA Designations

No designations recorded

Clinical trial landscape

JNJ-54135419 · 1 trial · 1 indication

Phase 1 1
NCT04282746A Study of Sublingually Administered (S)-Ketamine Oral Solution in Healthy ParticipantsHealthy
COMPLETED17 Analytics
PHASE1COMPLETED
A Study of Sublingually Administered (S)-Ketamine Oral Solution in Healthy Participants
Healthy
NCT0428274617
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Study Endpoints

Primary Endpoints

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 Endpoints

Number of Participants with Vital Sign Abnormalities
Up to 4 Weeks
Number of Participants with Adverse Events (AEs)
Up to 4 Weeks
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSEQUENTIAL
PurposeOTHER

Treatment Arms

ArmTypeDescription
JNJ-54135419EXPERIMENTALParticipants 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.

Interventions

NameTypeDescription
JNJ-54135419DRUGSingle dose of JNJ-54135419 oral solution will be administered sublingually.
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Eligibility Criteria

Age Range18 Years to 50 Years
SexALL
Healthy VolunteersYes
Study Sites1

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 re...

Countries:Belgium
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Frequently asked questions about JNJ-54135419

What is JNJ-54135419?

JNJ-54135419 is an investigational small molecule being developed by Johnson & Johnson (JNJ). It is currently in Phase 1 clinical development. The drug has been studied in healthy volunteers, and its therapeutic area is classified as Other. As of now, it remains investigational and has not been approved.

What is JNJ-54135419 used for?

JNJ-54135419 is being studied for use in healthy participants. The completed Phase 1 trial evaluated the drug in healthy volunteers, indicating its initial development focus is on safety and tolerability. Its intended therapeutic use has not been established, as it is still in early clinical development.

Who makes JNJ-54135419?

JNJ-54135419 is developed by Johnson & Johnson, a multinational pharmaceutical company traded on the NYSE under the ticker JNJ. The company is conducting clinical research on this small molecule drug candidate, which is currently in Phase 1 development.

What phase is JNJ-54135419 in?

JNJ-54135419 is in Phase 1 clinical development. The drug has completed one Phase 1 trial in healthy participants. It is investigational and has not been approved by regulatory authorities. Further clinical studies would be needed to advance its development.

What clinical trials is JNJ-54135419 in?

JNJ-54135419 has been studied in one completed Phase 1 clinical trial, identified as NCT04282746. This trial, titled 'A Study of Sublingually Administered (S)-Ketamine Oral Solution in Healthy Participants,' enrolled 17 healthy volunteers in Belgium. The study was uncontrolled and not randomized or double-blinded.