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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 is a Phase 1 study that has completed, run by Janssen Research & Development. The registered enrollment target is 151 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03682380
The ClinicalTrials.gov registry entry for NCT03682380 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 151 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Janssen Research & Development, which has 593 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Seltorexant High Dose is the first listed.
NCT03682380 reports 0 study locations.
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.
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