A Study of Sublingually Administered (S)-Ketamine Oral Solution in Healthy Participants
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|ClinicalTrials.gov Identifier: NCT04282746|
Recruitment Status : Recruiting
First Posted : February 25, 2020
Last Update Posted : June 29, 2020
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Drug: JNJ-54135419||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||18 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-label, Single Ascending Dose Study to Investigate the Safety, Tolerability and Pharmacokinetics of Sublingually Administered (S)-Ketamine Oral Solution in Healthy Participants|
|Actual Study Start Date :||February 18, 2020|
|Estimated Primary Completion Date :||June 30, 2020|
|Estimated Study Completion Date :||August 18, 2020|
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.
Single dose of JNJ-54135419 oral solution will be administered sublingually.
Other Name: (S)-ketamine
- Plasma Concentrations of (S)-ketamine [ Time Frame: 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 [ Time Frame: 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.
- Number of Participants with Vital Sign Abnormalities [ Time Frame: Up to 4 Weeks ]Number of participants with vital signs (heart rate [HR], systolic blood pressure [SBP], diastolic blood pressure [DBP]) abnormalities will be reported.
- Number of Participants with Adverse Events (AEs) [ Time Frame: Up to 4 Weeks ]An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product does not necessarily have a causal relationship with the treatment.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04282746
|Contact: Study Contact||844-434-4210||JNJ.CT@sylogent.com|
|SGS Life Science Services||Recruiting|
|Antwerpen, Belgium, 2060|
|Study Director:||Janssen Research & Development, LLC Clinical Trial||Janssen Research & Development, LLC|