HealthyPhase 1NCT03682380
A Study of Seltorexant (JNJ-42847922) After Single-Dose Administration in Healthy Participants
A Phase 1 study testing Seltorexant High Dose and Seltorexant Low Dose in people with Healthy, run by Janssen Research & Development, LLC at 1 site in United States.
Trial 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… 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 High Dose and Seltorexant Low Dose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 151 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2018to 23 Aug 2019
- 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
- Be healthy on the basis of medical history (screening only), physical examination, vital signs, and 12-lead electrocardiogram (ECG) performed at screening and Day 1 (predose)
- Be healthy on the basis of clinical laboratory tests performed at screening. If the results of the serum chemistry panel, hematology, or urinalysis are outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant. This determination must be recorded in the participant's source documents and initialed by the investigator
- 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 of each treatment period
- A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for at least 1 month after the last study drug administration
- A man, who is sexually active with a woman of childbearing potential and has not had a vasectomy, must agree to use an adequate contraception method as deemed appropriate by the investigator (for example, abstinence, vasectomy, barrier method, partner using effective contraception)
Who cannot join
- History of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders (including any abnormal bleeding or blood dyscrasias), lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, hepatic (Child-Pugh Score greater than or equal to [>=] 7) or renal insufficiency (estimated glomerular filtration rate [eGFR] less than [<] 60 milliliter per minute per 1.73 meter square [mL/min/1.73m^2] based on the modified diet renal disease [MDRD] formula at screening only), thyroid disease, neurologic (including seizure disorders) or psychiatric disease (depression or anxiety disorder in remission is acceptable), infection, or any other illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results. Significant past gastrointestinal medical history, or any disease/surgery that would with interfere drug absorption
- Clinically significant abnormal values for hematology, clinical chemistry (including thyroid stimulating hormone [TSH] at screening only) or urinalysis at screening or at admission to the study site. It is expected that laboratory values will generally be within the normal range for the laboratory, though minor deviations, which are not considered to be of clinical significance to the investigator, are acceptable
- Clinically significant abnormal physical examination, vital signs, or 12-lead ECG at screening or at admission to the study site though minor deviations, which are not considered to be of clinical significance to the investigator are acceptable
- Use of any prescription or nonprescription medication (including vitamins and herbal supplements), except for acetaminophen, oral contraceptives, and hormonal replacement therapy within 14 days before the first dose of the study drug is scheduled. Or has used any systemic herbal medications or dietary supplements including products containing Hypericum perforatum (for example, St. John's Wort) from 21 days before the first dose of study drug is scheduled
- Received a known inhibitor of Cytochrome P450 3A4 (CYP3A4) or CYP2C9 activity within 14 days or a period less than 5 times the drugs half-life; whichever is longer, before the first dose of the study drug is scheduled
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label, Randomized, Multi-panel, Crossover Study to Evaluate the Relative Oral Bioavailability and Food Effect of Seltorexant (JNJ-42847922) After Single-Dose Administration in Healthy Subjects
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.
- Conditions
- Healthy
- Being tested
- Seltorexant High Dose, Seltorexant Low Dose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Seltorexant High DoseDrug
Also called MIN-202, JNJ-42847922
In Part 1, Part 2, and Part 3 (3A and 3C), Seltorexant high dose (either a high dose tablet or two low dose tablets) will be administered orally.
Seltorexant Low DoseDrug
Also called MIN-202, JNJ-42847922
In Part 3 (3B and 3C), Seltorexant low dose will be administered orally.
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Seltorexant High Dose | Experimental | In Part 1, participants will receive the following treatments: Treatment A: Two low doses of seltorexant tablets (reference formulation), Treatment B: High dose of seltorexant tablet (Test formulation 1), Treatment C: High dose of seltorexant tablet (Test formulation 2), Treatment D: Two low doses of seltorexant tablets (Test formulation 3), Treatment E: Two low doses of seltorexant tablets (Test formulation 4), Treatment F: Two low doses of seltorexant tablets (Test formulation 5), as one of 6 possible treatment sequences on Day 1 in each treatment Periods (Period 1-6). There will be a washout Period of 7 to 14 days from dosing on Day 1 of each treatment period. Receives: Drug: Seltorexant High Dose |
| Part 2: Seltorexant High Dose | Experimental | Participants will receive the following treatments: Treatment G: Two low doses of seltorexant tablets (Reference formulation), Treatment H: High dose or two low doses of seltorexant tablet (Test formulation 1), Treatment I: High dose of seltorexant tablet (Test formulation 2), as one of 6 possible treatment sequences on Day 1 in each treatment Periods (Period 1-3). There will be a washout period of 7 to 14 days from dosing on Day 1 of each treatment period. Receives: Drug: Seltorexant High Dose |
| Part 3: Seltorexant Low Dose or High Dose | Experimental | Part 3 will have 3 subparts (Part 3A, Part 3B, and Part 3C). In Part 3A and 3B, participants will receive high dose of seltorexant (selected formulation 6) and two low doses of seltorexant (selected formulation 7) respectively in a different food conditions on Day 1 in each treatment Periods (Periods 1-5). In Part 3C, participants will receive high dose of seltorexant (selected formulation 6) and two low doses of seltorexant (selected formulation 7 ) on Day 1 in each period (Period 1 and 2). There will be a washout period of 7 to 14 days from dosing on Day 1 of each treatment period. Receives: Drug: Seltorexant High Dose; Drug: Seltorexant Low Dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed Plasma Concentration (Cmax)
Cmax is the maximum observed plasma concentration.
Measured: Predose up to 48 hours postdose
Area Under the Plasma Concentration-Time Curve from the Time of Dosing to the Last Measurable Plasma Concentration (AUC[0-last])
AUC(0-last) is the area under the plasma concentration-time curve from the time of dosing to the last measurable plasma concentration.
Measured: Predose up to 48 hours postdose
Area Under the Plasma Concentration-Time Curve Extrapolated to Infinite Time (AUC[0-infinity])
AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated using the observed value of the last non-zero plasma concentration.
Measured: Predose, up to 48 hours postdose
Secondary outcomes (6)
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Measured: Part 1: approximately 16 weeks; Part 2: approximately 10 weeks; Part 3: approximately 39 weeks
Dose-Proportionality of Seltorexant Based on Cmax
Dose proportionality of single doses of low dose and high dose of seltorexant from the Cmax will be assessed.
Measured: Predose up to 48 hours postdose
Dose-Proportionality of Seltorexant Based on AUC(0-last)
Dose proportionality of single doses of low dose and high dose of seltorexant from the AUC(0-last) will be assessed.
Measured: Predose up to 48 hours postdose
Dose-Proportionality of Seltorexant Based on AUC(0-infinity)
Dose proportionality of single doses of low dose and high dose of seltorexant from the AUC(0-infinity) will be assessed.
Measured: Predose up to 48 hours postdose
Plasma Protein Binding (PPB) of Seltorexant and Its Metabolites (M12 and M16)
Plasma protein binding (PPB) of seltorexant and its metabolites (M12 and M16) will be determined by using a qualified liquid chromatography coupled with tandem mass spectrometry (LC-MS/MS) method.
Measured: Predose up to 12 hours postdose
Change from Baseline in Karolinska Sleepiness Scale (KSS) Score
The KSS is a self reported, assessment of level of drowsiness at the time of scale administration. This scale is focused mainly on the propensity to fall asleep and has a high validity in measuring sleepiness. It consists of a 9-point Likert scale with response options from: 1=extremely alert, 2=very alert, 3=alert, 4=rather alert, 5=neither alert nor sleepy, 6= some signs of sleepiness, 7=sleepy (but no effort to keep awake), 8= sleepy, some effort to keep awake , 9=very sleepy (fighting sleep).
Measured: Baseline, Day 1, and Day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2018
- Study start1 Oct 2018
- Primary completion23 Aug 2019
- Study completion23 Aug 2019
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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 151 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
- NCT03682380
- Sponsor's protocol ID
- CR108503
- Other IDs
- 42847922MDD1011
- Status last verified
- Apr 2025
- First submitted
- 21 Sep 2018
- Last updated
- 27 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
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, Randomized, Multi-panel, Crossover Study to Evaluate the Relative Oral Bioavailability and Food Effect of Seltorexant (JNJ-42847922) After Single-Dose Administration in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03682380
- Acronym / sponsor ID
- CR108503
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 23 Aug 2019 (actual)
- Study completion
- 23 Aug 2019 (actual)
- First posted
- 24 Sep 2018 (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 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part 1: Seltorexant High Dose | Experimental | Drug: Seltorexant High DoseIn Part 1, participants will receive the following treatments: Treatment A: Two low doses of seltorexant tablets (reference formulation), Treatment B: High dose of seltorexant tablet (Test formulation 1), Treatment C: High dose of seltorexant tablet (Test formulation 2), Treatment D: Two low doses of seltorexant tablets (Test formulation 3), Treatment E: Two low doses of seltorexant tablets (Test formulation 4), Treatment F: Two low doses of seltorexant tablets (Test formulation 5), as one of 6 possible treatment sequences on Day 1 in each treatment Periods (Period 1-6). There will be a washout Period of 7 to 14 days from dosing on Day 1 of each treatment period. |
| Part 2: Seltorexant High Dose | Experimental | Drug: Seltorexant High DoseParticipants will receive the following treatments: Treatment G: Two low doses of seltorexant tablets (Reference formulation), Treatment H: High dose or two low doses of seltorexant tablet (Test formulation 1), Treatment I: High dose of seltorexant tablet (Test formulation 2), as one of 6 possible treatment sequences on Day 1 in each treatment Periods (Period 1-3). There will be a washout period of 7 to 14 days from dosing on Day 1 of each treatment period. |
| Part 3: Seltorexant Low Dose or High Dose | Experimental | Drug: Seltorexant High Dose, Drug: Seltorexant Low DosePart 3 will have 3 subparts (Part 3A, Part 3B, and Part 3C). In Part 3A and 3B, participants will receive high dose of seltorexant (selected formulation 6) and two low doses of seltorexant (selected formulation 7) respectively in a different food conditions on Day 1 in each treatment Periods (Periods 1-5). In Part 3C, participants will receive high dose of seltorexant (selected formulation 6) and two low doses of seltorexant (selected formulation 7 ) on Day 1 in each period (Period 1 and 2). There will be a washout period of 7 to 14 days from dosing on Day 1 of each treatment period. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Be healthy on the basis of medical history (screening only), physical examination, vital signs, and 12-lead electrocardiogram (ECG) performed at screening and Day 1 (predose)
- Be healthy on the basis of clinical laboratory tests performed at screening. If the results of the serum chemistry panel, hematology, or urinalysis are outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant. This determination must be recorded in the participant's source documents and initialed by the investigator
- 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 of each treatment period
- A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for at least 1 month after the last study drug administration
- A man, who is sexually active with a woman of childbearing potential and has not had a vasectomy, must agree to use an adequate contraception method as deemed appropriate by the investigator (for example, abstinence, vasectomy, barrier method, partner using effective contraception)
Key exclusion criteria (5 listed)
- History of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders (including any abnormal bleeding or blood dyscrasias), lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, hepatic (Child-Pugh Score greater than or equal to [>=] 7) or renal insufficiency (estimated glomerular filtration rate [eGFR] less than [<] 60 milliliter per minute per 1.73 meter square [mL/min/1.73m^2] based on the modified diet renal disease [MDRD] formula at screening only), thyroid disease, neurologic (including seizure disorders) or psychiatric disease (depression or anxiety disorder in remission is acceptable), infection, or any other illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results. Significant past gastrointestinal medical history, or any disease/surgery that would with interfere drug absorption
- Clinically significant abnormal values for hematology, clinical chemistry (including thyroid stimulating hormone [TSH] at screening only) or urinalysis at screening or at admission to the study site. It is expected that laboratory values will generally be within the normal range for the laboratory, though minor deviations, which are not considered to be of clinical significance to the investigator, are acceptable
- Clinically significant abnormal physical examination, vital signs, or 12-lead ECG at screening or at admission to the study site though minor deviations, which are not considered to be of clinical significance to the investigator are acceptable
- Use of any prescription or nonprescription medication (including vitamins and herbal supplements), except for acetaminophen, oral contraceptives, and hormonal replacement therapy within 14 days before the first dose of the study drug is scheduled. Or has used any systemic herbal medications or dietary supplements including products containing Hypericum perforatum (for example, St. John's Wort) from 21 days before the first dose of study drug is scheduled
- Received a known inhibitor of Cytochrome P450 3A4 (CYP3A4) or CYP2C9 activity within 14 days or a period less than 5 times the drugs half-life; whichever is longer, before the first dose of the study drug is scheduled
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 |
|---|---|---|
| Seltorexant High DoseAlso: MIN-202, JNJ-42847922In Part 1, Part 2, and Part 3 (3A and 3C), Seltorexant high dose (either a high dose tablet or two low dose tablets) will be administered orally. | Drug | Part 1: Seltorexant High Dose, Part 2: Seltorexant High Dose, Part 3: Seltorexant Low Dose or High Dose |
| Seltorexant Low DoseAlso: MIN-202, JNJ-42847922In Part 3 (3B and 3C), Seltorexant low dose will be administered orally. | Drug | Part 3: Seltorexant Low Dose or High Dose |
Primary outcome
Maximum Observed Plasma Concentration (Cmax)
Time frame: Predose up to 48 hours postdose
Cmax is the maximum observed plasma concentration.
Area Under the Plasma Concentration-Time Curve from the Time of Dosing to the Last Measurable Plasma Concentration (AUC[0-last])
Time frame: Predose up to 48 hours postdose
AUC(0-last) is the area under the plasma concentration-time curve from the time of dosing to the last measurable plasma concentration.
Area Under the Plasma Concentration-Time Curve Extrapolated to Infinite Time (AUC[0-infinity])
Time frame: Predose, up to 48 hours postdose
AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated using the observed value of the last non-zero plasma concentration.
6 secondary outcomes
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: Part 1: approximately 16 weeks; Part 2: approximately 10 weeks; Part 3: approximately 39 weeks
Dose-Proportionality of Seltorexant Based on Cmax
Time frame: Predose up to 48 hours postdose
Dose-Proportionality of Seltorexant Based on AUC(0-last)
Time frame: Predose up to 48 hours postdose
Dose-Proportionality of Seltorexant Based on AUC(0-infinity)
Time frame: Predose up to 48 hours postdose
Plasma Protein Binding (PPB) of Seltorexant and Its Metabolites (M12 and M16)
Time frame: Predose up to 12 hours postdose
Change from Baseline in Karolinska Sleepiness Scale (KSS) Score
Time frame: Baseline, Day 1, and Day 2
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.
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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 High Dose and Seltorexant Low Dose in people with Healthy, run by Janssen Research & Development, LLC at 1 site in United States.
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 United States. 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?
Maximum Observed Plasma Concentration (Cmax) (time frame: Predose up to 48 hours postdose). The study lists 3 primary outcomes in all. 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.