NCT03808259

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

A Randomized, Participant- and Investigator Blind, Double Dummy, Placebo- and Comparator-controlled, Single Ascending Dose and Parallel-group Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Different Modes of (S) Ketamine Administration in Healthy Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 96 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2018-12-20
• Primary completion: 2019-09-04
• Completion: 2019-09-04
• First posted: 2019-01-17
• Last updated: 2025-04-27

Locations

1 site across 1 country: Belgium