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| ID | Type | Description | Link |
|---|---|---|---|
| 42847922MDD1019 | Other Identifier | Janssen Research & Development, LLC | |
| 2021-004068-92 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Seltorexant | Drug | Seltorexant will be administered orally as a tablet and as an intravenous infusion of 14C-seltorexant. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to Day 4 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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]) |
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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 |
|---|---|---|---|---|---|---|
| PRA Health Sciences Onderzoekscentrum Groningen, locatie Martini | Groningen | 9728 NZ | Netherlands |
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
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| ID | Term |
|---|---|
| C000655226 | seltorexant |
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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. |
| Up to Day 4 |
| Maximum Observed Plasma Analyte Concentration (Cmax) of Seltorexant | Cmax of Seltorexant will be reported. | Up to Day 4 |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) of Seltorexant | Tmax of Seltorexant will be reported. | 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). | 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. | Screening (up to -21 days) up to Day 7 |