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| ID | Type | Description | Link |
|---|---|---|---|
| 42847922MDD1011 | Other Identifier | Janssen Research & Development, LLC |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Seltorexant High Dose | Drug | 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) | Cmax is the maximum observed plasma concentration. | 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. | 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. | Predose, up to 48 hours postdose |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Part 1: approximately 16 weeks; Part 2: approximately 10 weeks; Part 3: approximately 39 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PRAHS | Salt Lake City | Utah | 84124 | United States |
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| ID | Term |
|---|---|
| C000655226 | seltorexant |
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| Seltorexant Low Dose | Drug | In Part 3 (3B and 3C), Seltorexant low dose will be administered orally. |
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| 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. | 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. | 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. | 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. | 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). | Baseline, Day 1, and Day 2 |