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| ID | Type | Description | Link |
|---|---|---|---|
| 42847922MDD1018 | Other Identifier | Janssen Research & Development, LLC |
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The purpose of this study is to evaluate the bioequivalence of Test 1 and/or Test 2 seltorexant tablet formulations with respect to Reference seltorexant tablet formulation in healthy participants receiving a single dose under fasted conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Sequence ABC | Experimental | Participants will receive a single dose of seltorexant as formulation (Test 1) (Treatment A) in Treatment Period 1, followed by a single dose of seltorexant as formulation (Test 2) (Treatment B) in Treatment Period 2, followed by a single dose of seltorexant as formulation (Reference) (Treatment C) in Treatment Period 3 on Day 1 of each Treatment Period under fasted condition. There will be a washout period of 7 to 14 days from dosing on Day 1 of each Treatment Period. |
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| Treatment Sequence BCA | Experimental | Participants will receive Treatment B in Treatment Period 1, followed by Treatment C in Treatment Period 2, followed by Treatment A in Treatment Period 3 on Day 1 of each Treatment Period under fasted condition. There will be a washout period of 7 to 14 days from dosing on Day 1 of each Treatment Period. |
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| Treatment Sequence CAB | Experimental | Participants will receive Treatment C in Treatment Period 1, followed by Treatment A in Treatment Period 2, followed by Treatment B in Treatment Period 3 on Day 1 of each Treatment Period under fasted condition. There will be a washout period of 7 to 14 days from dosing on Day 1 of each Treatment Period. |
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| Treatment Sequence CBA | Experimental | Participants will receive Treatment C in Treatment Period 1, followed by Treatment B in Treatment Period 2, followed by Treatment A in Treatment Period 3 on Day 1 of each Treatment Period under fasted condition. 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 | Drug | Seltorexant will be administered orally as per assigned treatment sequence. |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) of Seltorexant and its Metabolites | Cmax is defined as the maximum observed plasma concentration of seltorexant and its metabolites. | Predose, up to 48 hours post dose (Day 3) |
| Last Observed Measurable Plasma Concentration (Clast) of Seltorexant and its Metabolites | Clast is defined as the last observed measurable (non-below quantification limit [non-BQL]) plasma concentration of seltorexant and its metabolites. | Predose, up to 48 hours post dose (Day 3) |
| Time to Reach the Maximum Observed Plasma Concentration (Tmax) of Seltorexant and its Metabolites | Tmax is defined as the actual sampling time to reach the maximum observed plasma concentration of seltorexant and its metabolites. | Predose, up to 48 hours post dose (Day 3) |
| Area Under the Concentration-time Curve From Time Zero to Time of the Last Measurable Plasma Concentration (AUC [0-last]) of Seltorexant and its Metabolites | AUC (0-last) is defined as area under the plasma concentration-time curve from the time of dosing to the last measurable plasma concentration of seltorexant and its metabolites. | Predose, up to 48 hours post dose (Day 3) |
| Area Under the Plasma Concentration-time Curve from Time Zero to Infinity (AUC [0-infinity]) of Seltorexant and its Metabolites | AUC (0-infinity) is defined as area under the plasma concentration-time curve of seltorexant and its metabolites extrapolated to infinity, calculated using the linear trapezoidal method from time zero to infinite time calculated as the sum of AUC(0-last)+C(last)/ lambda(z). | Predose, up to 48 hours post dose (Day 3) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events (AEs) including AEs of Special Interest (AESI) as a Measure of Safety and Tolerability | Number of participants with an AE including AE of special interest as a measure of safety and tolerability will be reported. An AE is any untoward medical occurrence in a clinical study participant administered a investigational or non-investigational medicinal product. An AE does not necessarily have a causal relationship with the treatment. AESI will comprise of cataplexy, sleep paralysis, complex, sleep-related behaviors/parasomnias, sleep terrors, bruxism, sleep sex, sleep related eating disorder, sleep behavior disorder, catathrenia and abnormal (vivid) dreams. |
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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 | Salt Lake City | Utah | 84124 | United States |
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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| Treatment Sequence ACB | Experimental | Participants will receive Treatment A in Treatment Period 1, followed by Treatment C in Treatment Period 2, followed by Treatment B in Treatment Period 3 on Day 1 of each Treatment Period under fasted condition. There will be a washout period of 7 to 14 days from dosing on Day 1 of each Treatment Period. |
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| Treatment Sequence BAC | Experimental | Participants will receive Treatment B in Treatment Period 1, followed by Treatment A in Treatment Period 2, followed by Treatment C in Treatment Period 3 on Day 1 of each Treatment Period under fasted condition. There will be a washout period of 7 to 14 days from dosing on Day 1 of each Treatment Period. |
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| Apparent Terminal Elimination Half-life (t1/2) of Seltorexant and its Metabolites |
Apparent elimination half-life associated with the terminal slope lambda(z) of the semilogarithmic drug concentration-time curve of seltorexant and its metabolites. |
| Predose, up to 48 hours post dose (Day 3) |
| Up to 11 Weeks |
| Number of Participants with Laboratory Abnormalities | Number of participants with laboratory abnormalities related to hematology, serum chemistry, coagulation, and urinalysis will be reported. | Up to 11 Weeks |
| Number of Participants with Clinically Significant Changes in Vital Signs | Number of participants with clinically significant changes in vital signs including blood pressure, heart rate, respiratory rate, oral temperature will be reported. | Up to 11 Weeks |
| Number of Participants with Abnormalities in Electrocardiogram (ECG) | Number of participants with abnormalities in ECG will be reported. | Up to 11 Weeks |
| Number of Participants with Clinically Significant Changes in Physical Examination | Number of participants with clinically significant changes in physical examination including height and body weight will be reported. | Up to 11 Weeks |