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NCT03682380 · ClinicalTrials.gov registry record · Phase 1
A Study of Seltorexant (JNJ-42847922) After Single-Dose Administration in Healthy Participants
A Phase 1 study, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 1
- Development phase
- 151
- Enrollment target
NCT03682380: Completed Phase 1 study, sponsored by Janssen Research & Development.
NCT03682380 is a Phase 1 study that has completed, run by Janssen Research & Development. The registered enrollment target is 151 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (152% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03682380, a Phase 1 study, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 151 participants
- Enrollment target
Study Summary
The purpose of this study is to compare the rate and extent of absorption (relative bioavailability) of seltorexant Phase 3 test formulation(s) relative to a reference Phase 2b tablet formulation dosed in the evening under fasted and semi-fasted conditions (3 hours after meal); to assess the effect of type and timing of the meal on the rate and extent of absorption of seltorexant Phase 3 tablet formulation (low dose and high dose strength) in healthy male and female participants; and to assess the pharmacokinetic of single-dose administration of low dose and high dose of seltorexant in healthy male and female participants 3 hours after meal.
Primary Outcome
Cmax is the maximum observed plasma concentration.
Interventions
- DRUG Seltorexant High Dose
- DRUG Seltorexant Low Dose
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 151 participants |
| Start Date | 2018-10-01 |
| Est. Completion | 2019-08-23 |
| Phase | Phase 1 |
What the finished NCT03682380 record still lists
NCT03682380 is an interventional study that assigns participants to a tested intervention. The registered 151 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (152% higher).
The record links to 0 conditions, and to 2 interventions - of which Seltorexant High Dose is the first listed.
NCT03682380 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03682380 about?
NCT03682380 is a clinical study titled "A Study of Seltorexant (JNJ-42847922) After Single-Dose Administration in Healthy Participants". The purpose of this study is to compare the rate and extent of absorption (relative bioavailability) of seltorexant Phase 3 test formulation(s) relative to a reference Phase 2b tablet formulation dosed in the evening under fasted and semi-fasted conditions (3 hours after meal); to assess the effect ...
What is the current status of trial NCT03682380?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 151 participants. The study started on 2018-10-01. Estimated completion is 2019-08-23.
What interventions are being tested in trial NCT03682380?
The interventions under investigation include: Seltorexant High Dose (DRUG), Seltorexant Low Dose (DRUG).
Who is sponsoring clinical trial NCT03682380?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03682380's enrollment target sits among peer trials
151 363rd of 2000 higher than 1,638 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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