HealthyPhase 1NCT05236868
A Study of JNJ-42847922 (Seltorexant) in Healthy Participants
A Phase 1 study testing Seltorexant in people with Healthy, run by Janssen Research & Development, LLC at 1 site in Netherlands.
Trial summary
The purpose of this study is to determine the absolute bioavailability of seltorexant in healthy participants following a single oral dose of seltorexant and an intravenous (IV) infusion dose of 14C-seltorexant. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Seltorexant
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteNetherlands
- Study dates
- 3 Feb 2022to 1 Mar 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy on the basis of medical history at screening and physical examination, vital signs, and 12-lead electrocardiogram (ECG) performed at screening and at admission to the study site on Day 1
- Healthy on the basis of clinical laboratory tests performed at screening and at admission to the study site on Day -1
- All female participants (regardless of childbearing potential), must have a negative serum beta-human chorionic gonadotropin (beta-hCG) pregnancy test at screening and a negative urine pregnancy test on Day -1
- A woman must be a) Not of childbearing potential; b) Of childbearing potential and practicing a highly effective method of contraception (failure rate of less than (<) 1 percent (%) per year when used consistently and correctly) and agrees to remain on a highly effective method while receiving study intervention and until 3 months after the study treatment administration
- Must sign an informed consent form (ICF) indicating that the participant understands the purpose of, and procedures required for, the study and is willing to participate in the study
Who cannot join
- Clinically significant abnormal values for hematology, clinical chemistry, or urinalysis at screening or at admission to the study site (Day -1) as determined by the investigator. Alanine transaminase (ALT)/aspartate transaminase (AST) concentrations within normal range at screening. One retest for ALT/AST is permitted
- Clinically significant abnormal physical examination, vital signs, or 12-lead (ECG) at screening or at admission to the study site on Day -1 as determined by the investigator
- Participant has a current or recent history of serious suicidal ideation within the past 6 months, corresponding to a positive response on item 4 (active suicidal ideation with some intent to act, without specific plan) or item 5 (active suicidal ideation with specific plan and intent) for ideation on the Columbia-Suicide Severity Rating Scale (C SSRS), or a lifetime history of suicidal behavior or suicidal attempt as validated by the C SSRS at screening
- Positive test for human immunodeficiency virus (HIV)-1 and HIV-2 antibodies, hepatitis B surface antigen (HBsAg), or hepatitis C antibodies
- Has any history or current diagnosis of obstructive sleep apnea or parasomnias. Participants with restless leg syndrome/periodic leg movement disorder or insomnia disorder are allowed if not requiring medication
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
PRA Health Sciences Onderzoekscentrum Groningen, locatie Martini
Groningen, 9728 NZ
About this study
Official title: An Open-Label, Single-Dose Study to Assess the Absolute Oral Bioavailability and Pharmacokinetics of JNJ-42847922 (Seltorexant) Administered as Oral Tablet and an Intravenous Microdose of 14C-seltorexant in Healthy Participants
The purpose of this study is to determine the absolute bioavailability of seltorexant in healthy participants following a single oral dose of seltorexant and an intravenous (IV) infusion dose of 14C-seltorexant.
- Conditions
- Healthy
- Being tested
- Seltorexant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SeltorexantDrug
Also called JNJ-42847922
Seltorexant will be administered orally as a tablet and as an intravenous infusion of 14C-seltorexant.
| Study group | Role | What they receive |
|---|---|---|
| Seltorexant | Experimental | Participants will receive a single oral dose of seltorexant. At 2 hours after oral dosing, participants will receive 14C-seltorexant as an intravenous (IV) infusion over 15 minutes. Receives: Drug: Seltorexant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute Bioavailability
Absolute bioavailability is calculated as the ratio of dose normalized area under the plasma drug concentration-time curve (AUC) of oral and intravenous (IV) administration.
Measured: Up to Day 4
Secondary outcomes (6)
Area Under the Plasma Analyte Concentration Versus Time Curve of Seltorexant from Time Zero to Infinite time (AUC [0-Infinity])
AUC (0-infinity) is defined as the area under the plasma analyte concentration versus time curve of seltorexant from time zero to infinite time.
Measured: Up to Day 4
Area Under the Plasma Analyte Concentration Versus Time Curve of Seltorexant from Time Zero to Time of the Last Measurable Concentration (AUC [0-Last])
AUC (0-Last) is defined as area under the plasma analyte concentration versus time curve from time zero to time of the last measurable (non- below quantifiable limit [BQL]) concentration.
Measured: Up to Day 4
Maximum Observed Plasma Analyte Concentration (Cmax) of Seltorexant
Cmax of Seltorexant will be reported.
Measured: Up to Day 4
Time to Reach Maximum Observed Plasma Concentration (Tmax) of Seltorexant
Tmax of Seltorexant will be reported.
Measured: Up to Day 4
Apparent Terminal Elimination Half-life (t1/2) of Seltorexant
Apparent terminal elimination half-life is calculated as 0.693/ lambda(z).
Measured: Up to Day 4
Number of Participants with Adverse Events (AEs)
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
Measured: Screening (up to -21 days) up to Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2022
- Study start3 Feb 2022
- Primary completion1 Mar 2022
- Study completion1 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05236868
- Sponsor's protocol ID
- CR109133
- Other IDs
- 42847922MDD1019, 2021-004068-92
- Status last verified
- Apr 2025
- First submitted
- 2 Feb 2022
- Last updated
- 27 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Single-Dose Study to Assess the Absolute Oral Bioavailability and Pharmacokinetics of JNJ-42847922 (Seltorexant) Administered as Oral Tablet and an Intravenous Microdose of 14C-seltorexant in Healthy Participants
- ClinicalTrials.gov ID
- NCT05236868
- Acronym / sponsor ID
- CR109133
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 3 Feb 2022 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 11 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the absolute bioavailability of seltorexant in healthy participants following a single oral dose of seltorexant and an intravenous (IV) infusion dose of 14C-seltorexant.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Seltorexant | Experimental | Drug: SeltorexantParticipants will receive a single oral dose of seltorexant. At 2 hours after oral dosing, participants will receive 14C-seltorexant as an intravenous (IV) infusion over 15 minutes. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy on the basis of medical history at screening and physical examination, vital signs, and 12-lead electrocardiogram (ECG) performed at screening and at admission to the study site on Day 1
- Healthy on the basis of clinical laboratory tests performed at screening and at admission to the study site on Day -1
- All female participants (regardless of childbearing potential), must have a negative serum beta-human chorionic gonadotropin (beta-hCG) pregnancy test at screening and a negative urine pregnancy test on Day -1
- A woman must be a) Not of childbearing potential; b) Of childbearing potential and practicing a highly effective method of contraception (failure rate of less than (<) 1 percent (%) per year when used consistently and correctly) and agrees to remain on a highly effective method while receiving study intervention and until 3 months after the study treatment administration
- Must sign an informed consent form (ICF) indicating that the participant understands the purpose of, and procedures required for, the study and is willing to participate in the study
Key exclusion criteria (5 listed)
- Clinically significant abnormal values for hematology, clinical chemistry, or urinalysis at screening or at admission to the study site (Day -1) as determined by the investigator. Alanine transaminase (ALT)/aspartate transaminase (AST) concentrations within normal range at screening. One retest for ALT/AST is permitted
- Clinically significant abnormal physical examination, vital signs, or 12-lead (ECG) at screening or at admission to the study site on Day -1 as determined by the investigator
- Participant has a current or recent history of serious suicidal ideation within the past 6 months, corresponding to a positive response on item 4 (active suicidal ideation with some intent to act, without specific plan) or item 5 (active suicidal ideation with specific plan and intent) for ideation on the Columbia-Suicide Severity Rating Scale (C SSRS), or a lifetime history of suicidal behavior or suicidal attempt as validated by the C SSRS at screening
- Positive test for human immunodeficiency virus (HIV)-1 and HIV-2 antibodies, hepatitis B surface antigen (HBsAg), or hepatitis C antibodies
- Has any history or current diagnosis of obstructive sleep apnea or parasomnias. Participants with restless leg syndrome/periodic leg movement disorder or insomnia disorder are allowed if not requiring medication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SeltorexantAlso: JNJ-42847922Seltorexant will be administered orally as a tablet and as an intravenous infusion of 14C-seltorexant. | Drug | Seltorexant |
Primary outcome
Absolute Bioavailability
Time frame: Up to Day 4
Absolute bioavailability is calculated as the ratio of dose normalized area under the plasma drug concentration-time curve (AUC) of oral and intravenous (IV) administration.
6 secondary outcomes
Area Under the Plasma Analyte Concentration Versus Time Curve of Seltorexant from Time Zero to Infinite time (AUC [0-Infinity])
Time frame: Up to Day 4
Area Under the Plasma Analyte Concentration Versus Time Curve of Seltorexant from Time Zero to Time of the Last Measurable Concentration (AUC [0-Last])
Time frame: Up to Day 4
Maximum Observed Plasma Analyte Concentration (Cmax) of Seltorexant
Time frame: Up to Day 4
Time to Reach Maximum Observed Plasma Concentration (Tmax) of Seltorexant
Time frame: Up to Day 4
Apparent Terminal Elimination Half-life (t1/2) of Seltorexant
Time frame: Up to Day 4
Number of Participants with Adverse Events (AEs)
Time frame: Screening (up to -21 days) up to Day 7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2025.
- Individual participant dataSharing planned: Yes. The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Research & Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Seltorexant in people with Healthy, run by Janssen Research & Development, LLC at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absolute Bioavailability (time frame: Up to Day 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2025.