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JNJ-54135419

Phase 1

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment17
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04282746A Study of Sublingually Administered (S)-Ketamine Oral Solution in Healthy ParticipantsPHASE1 COMPLETED 17 — — Feb 18, 2020Aug 17, 2020Apr 27, 20251 Belgium
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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 — 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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