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| ID | Type | Description | Link |
|---|---|---|---|
| 42847922MDD1004 | Other Identifier | Janssen Research & Development, LLC |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 | Experimental | In Part 1, all participants will receive a single oral dose of seltorexant (40 milligram [mg]) in all the 6 treatments as Treatment A (Formulation 1 in fasted state), B (Formulation 1 in semi-fasted state), C (Formulation 2 in fasted state), D (Formulation 2 in semi-fasted state), E (Formulation 3 in fasted state) and F (Formulation 3 in semi-fasted state) and the participants will be assigned to one of the 8 sequences (that is, ADBCEF, ADBCFE, BACDEF, BACDFE, CBDAEF, CBDAFE, DCABEF, DCABFE). A washout period of at least 7 days between subsequent study drug administrations on Day 1 of each treatment period will be maintained. |
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| Part 2 (Optional) | Experimental | Optional Part 2 will only be performed if considered to be warranted by the sponsor based on the preliminary pharmacokinetic (PK) analysis of the results from Part 1. Participants will receive a single oral dose of seltorexant (20 mg) as 3 different formulations assigned to one of the either 6 or 4 treatment sequences under fasted or semi-fasted conditions. The treatment will be assigned in 1 of the 6 or 4 assigned sequences per treatment period that is either Period 1 to 6 or Period 1 to 4). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Seltorexant 40 mg | Drug | Seltorexant 40 mg as two tablets of 20 mg will be administered as Formulation 1, 2 and 3 orally in Part 1. |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) when Compared for 3 Oral Tablet Formulations of Seltorexant | 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. | Predose, 20 minutes (min), 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 20h (Day 1), 24h, 36h (Day 2), 48h (Day 3) postdose |
| Area Under the Plasma Concentration-Time Curve from the Time of Study Drug Administration to the Last Measurable Plasma Concentration (AUC[0-last]) when Compared for 3 Oral Tablet Formulations of Seltorexant | AUC (0-last) is the area under the plasma concentration-time curve from the time of study drug administration to the last measurable plasma concentration and will be evaluated when compared for 3 oral tablet formulations of seltorexant in fasted and semi-fasted conditions. | Predose, 20 minutes (min), 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 20h (Day 1), 24h, 36h (Day 2), 48h (Day 3) postdose |
| Area Under the Plasma Concentration-Time Curve Extrapolated to Infinite Time (AUC[0-infinity]) when Compared for 3 Oral Tablet Formulations of Seltorexant | AUC (0-infinity) is the 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 and will be evaluated when compared for 3 oral tablet formulations of seltorexant in fasted and semi-fasted conditions. | Predose, 20 minutes (min), 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 20h (Day 1), 24h, 36h (Day 2), 48h (Day 3) postdose |
| Relative Bioavailability of Seltorexant when Compared for 3 Oral Tablet Formulations of Seltorexant | Relative bioavailability is the percentage of the administered dose that is systemically available, calculated as: (AUC [0-infinity] of test divided by AUC [0-infinity] of reference) multiplied by 100, where the reference treatment is a non-intravenous administration. Relative bioavailability will be evaluated when compared for 3 oral tablet formulations of seltorexant in fasted and semi-fasted conditions. |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax when Compared Between Fasted and Semi-Fasted Conditions | Cmax when compared between fasted and semi-fasted conditions will be evaluated for the 3 oral tablet formulations of seltorexant. | Predose, 20 minutes (min), 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 20h (Day 1), 24h, 36h (Day 2), 48h (Day 3) postdose |
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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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| Seltorexant 20 mg | Drug | Seltorexant as a tablet of 20 mg will be administered as Formulation 1, 2 and 3 orally in Part 2. |
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| Predose, 20 minutes (min), 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 20h (Day 1), 24h, 36h (Day 2), 48h (Day 3) postdose |
| AUC (0-last) when Compared Between Fasted and Semi-Fasted Conditions | AUC (0-last) when compared between fasted and semi-fasted conditions will be evaluated for the 3 oral tablet formulations of seltorexant. | Predose, 20 minutes (min), 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 20h (Day 1), 24h, 36h (Day 2), 48h (Day 3) postdose |
| AUC (0-infinity) when Compared Between Fasted and Semi-Fasted Conditions | AUC (0-infinity) when compared between fasted and semi-fasted conditions will be evaluated for the 3 oral tablet formulations of seltorexant. | Predose, 20 minutes (min), 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 20h (Day 1), 24h, 36h (Day 2), 48h (Day 3) postdose |
| 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. | From Screening till End-of- Study (up to approximately 18 weeks) |
| ID | Term |
|---|---|
| C000655226 | seltorexant |
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