Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 1 study of Healthy, sponsored by Janssen Research & Development.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Cmax is the maximum observed plasma concentration and will be evaluated when compared for 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 |
What the finished NCT03438461 record still lists
NCT03438461 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 49 participants, a relatively small participant target, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (92% lower).
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 a single indexed study location in 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.
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 NCT03438461's enrollment target sits among peer trials
49 474th of 1090 higher than 613 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.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Assessment of Neuroinflammation in Central Inflammatory Disorders Using [F-18]DPA-714.
RECRUITING · Phase 1
-
A Study of LY3867070 in Healthy Participants
RECRUITING · Phase 1
-
A Study to Investigate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of AZD1613 in Healthy Participants.
RECRUITING · Phase 1
-
Evaluate the Pharmacokinetics, Safety, and Tolerability of NSHO-101 in Healthy Participants
RECRUITING · Phase 1
-
Comparison of the Short-Term Effect of Dietary Carbohydrate Restriction Versus Exogenous Ketone Supplementation on Myocardial Glucose Suppression and Timing to Achieve a State of Ketosis Using FDG PET/CT Serial Imaging
RECRUITING · Phase 1
-
A Study of V118E in Healthy Participants (V118E-003)
RECRUITING · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02704858 · 49 participants · Phase 1
Safety and Efficacy Study in Recurrent or Progressive Grade III or IV IDH1 Mutated Glioma
- NCT03516708 · 49 participants · Phase 1
Epacadostat (INCB024360) Added to Preoperative Chemoradiation in Patients With Locally Advanced Rectal Cancer
- NCT03692429 · 49 participants · Phase 1
alloSHRINK - Standard cHemotherapy Regimen and Immunotherapy With Allogeneic NKG2D-based CYAD-101 Chimeric Antigen Receptor T-cells
- NCT04329494 · 49 participants · Phase 1
PIPAC for the Treatment of Peritoneal Carcinomatosis in Patients With Ovarian, Uterine, Appendiceal, Colorectal, or Gastric Cancer
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI