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NCT03438461 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate the Relative Oral Bioavailability of Seltorexant (JNJ-42847922) After Administration of 3 Different Formulations in Healthy Participants Under Fasted and Semi-fasted Conditions
A Phase 1 study of Healthy, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 1
- Development phase
- 49
- Enrollment target
- 1
- Study location
NCT03438461 is a Phase 1 study of Healthy that has completed, run by Janssen Research & Development. The registered enrollment target is 49 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state.
The verdict
NCT03438461, a Phase 1 study of Healthy, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 49 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to assess and compare the pharmacokinetics (PK) and relative oral bioavailability of 3 oral tablet formulations of seltorexant in fasted and semi-fasted conditions.
Conditions Studied
Interventions
- DRUG Seltorexant 40 mg
- DRUG Seltorexant 20 mg
Study Locations (1)
Utah
- PRAHS - Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 49 participants |
| Start Date | 2018-02-09 |
| Est. Completion | 2018-05-30 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03438461
The ClinicalTrials.gov registry entry for NCT03438461 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 49 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (92% lower). The listed sponsor is Janssen Research & Development, which has 593 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Healthy appearing as the primary indexed condition, and to 2 interventions - of which Seltorexant 40 mg is the first listed.
NCT03438461 reports 1 study location spanning 1 distinct geographic area - top geographies include Utah.
Frequently Asked Questions
What is clinical trial NCT03438461 about?
NCT03438461 is a clinical study titled "A Study to Evaluate the Relative Oral Bioavailability of Seltorexant (JNJ-42847922) After Administration of 3 Different Formulations in Healthy Participants Under Fasted and Semi-fasted Conditions". The purpose of this study is to assess and compare the pharmacokinetics (PK) and relative oral bioavailability of 3 oral tablet formulations of seltorexant in fasted and semi-fasted conditions.
What is the current status of trial NCT03438461?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 49 participants. The study started on 2018-02-09. Estimated completion is 2018-05-30.
What conditions does trial NCT03438461 study?
This clinical trial studies the following conditions: Healthy.
What interventions are being tested in trial NCT03438461?
The interventions under investigation include: Seltorexant 40 mg (DRUG), Seltorexant 20 mg (DRUG).
Who is sponsoring clinical trial NCT03438461?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03438461 being conducted?
This trial has 1 study location across Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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