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NCT02846519 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetic, Safety, and Tolerability Study of Intranasally Administered Esketamine in Healthy Han Chinese, Korean, Japanese, and Caucasian Participants and the Effects of Rifampin on the Pharmacokinetics of Intranasally Administered Esketamine
A Phase 1 study of Healthy, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 1
- Development phase
- 66
- Enrollment target
- 1
- Study location
NCT02846519: Completed Phase 1 study of Healthy, sponsored by Janssen Research & Development.
NCT02846519 is a Phase 1 study of Healthy that has completed, run by Janssen Research & Development. The registered enrollment target is 66 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02846519, a Phase 1 study of Healthy, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 66 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to evaluate the pharmacokinetics of intranasally administered esketamine in healthy Han Chinese, Korean, Japanese, and Caucasian participants and to evaluate the effects of rifampin on the pharmacokinetics of intranasally administered esketamine in healthy Caucasian participants.
Primary Outcome
The Cmax is the maximum observed plasma concentration.
Conditions Studied
Interventions
- DRUG Rifampin
- DRUG Esketamine
Study Locations (1)
California
- - Cypress
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 66 participants |
| Start Date | 2016-02-26 |
| Est. Completion | 2016-05-28 |
| Phase | Phase 1 |
What the finished NCT02846519 record still lists
NCT02846519 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 66 participants, a relatively small participant target, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (90% lower).
The record links to 1 condition, with Healthy appearing as the primary indexed condition, and to 2 interventions - of which Rifampin is the first listed.
NCT02846519 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT02846519 about?
NCT02846519 is a clinical study titled "Pharmacokinetic, Safety, and Tolerability Study of Intranasally Administered Esketamine in Healthy Han Chinese, Korean, Japanese, and Caucasian Participants and the Effects of Rifampin on the Pharmacokinetics of Intranasally Administered Esketamine". The purpose of this study is to evaluate the pharmacokinetics of intranasally administered esketamine in healthy Han Chinese, Korean, Japanese, and Caucasian participants and to evaluate the effects of rifampin on the pharmacokinetics of intranasally administered esketamine in healthy Caucasian part...
What is the current status of trial NCT02846519?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 66 participants. The study started on 2016-02-26. Estimated completion is 2016-05-28.
What conditions does trial NCT02846519 study?
This clinical trial studies the following conditions: Healthy.
What interventions are being tested in trial NCT02846519?
The interventions under investigation include: Rifampin (DRUG), Esketamine (DRUG).
Who is sponsoring clinical trial NCT02846519?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02846519 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Healthy
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02846519's enrollment target sits among peer trials
66 342nd of 1090 higher than 740 of 1,090 other Healthy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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