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A Study to Investigate the Different Modes of (S) Ketamine Administration in Healthy Participants

NCT03808259 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2025-04-27

No results posted yet for this study

Summary

The purpose of this study is to determine the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of different modes of (S) ketamine administration in healthy participants.

Conditions

  • Healthy

Interventions

DRUG

(S)-ketamine Oral Thin Film

(S)-ketamine OTF sublingual formulation at a dose of 7 mg, 14 mg, and 28 mg will be administered in sequential cohorts.

DRUG

(S)-ketamine IV Infusion

(S)-ketamine IV solution will be infused at a dose of less than or equal to 14mg.

DRUG

Placebo

Participants will receive matching placebo.

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Research & Development, LLC Clinical Trial · Janssen Research & Development, LLC

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-12-20
Primary Completion
2019-09-04
Completion
2019-09-04

Countries

  • Belgium

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03808259 on ClinicalTrials.gov