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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-004770-33 | EudraCT Number | ||
| 42847922MDD1007 | Other Identifier | Janssen Research & Development, LLC |
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The purpose of this study is to assess the effects of single dose seltorexant on QT/QTc intervals and electrocardiogram (ECG) morphology at therapeutic and supratherapeutic exposures in healthy adult participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Seltorexant (Low and high dose) | Experimental | Participants will receive seltorexant tablets orally in 2 of 4 treatment arms (A,B,C,D) in a cross-over design, with 7 days wash-out phase between each treatment period. |
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| Moxifloxacin | Experimental | Participants will receive moxifloxacin tablets orally in 1 of 4 treatment arms (A,B,C,D) in a cross-over design, with 7 days wash-out phase between each treatment period. |
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| Placebo Matched to Seltorexant | Experimental | Participants will receive seltorexant placebo tablets orally in 3 of 4 treatment arms (A,B,C,D) in a cross-over design, with 7 days wash-out phase between each treatment period. |
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| Placebo Matched to Moxifloxacin | Experimental | Participants will receive moxifloxacin placebo tablets orally in 3 of 4 treatment arms (A,B,C,D) in a cross-over design, with 7 days wash-out phase between each treatment period. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Seltorexant | Drug | Participants will be administered oral dose of seltorexant over-encapsulated tablets on Day 1. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in QT/QTc Intervals | Change from baseline in QT and QTc interval will be assessed. QT interval will be measured in triplicates from 12 lead Holter extracted triplicate ECG recordings and corrected QT (QTc) interval will be calculated based on Fridericia (QTcF), Bazett (QTcB), and/or study specific power (QTcP) equations. | Baseline up to Day 3 |
| Percentage of Participants with Change from Baseline in T-wave Morphology | The percentage of participants in each treatment having T-wave morphology changes from baseline that represent the appearance or worsening of the morphological abnormality will be reported. | Baseline up to Day 3 |
| Percentage of Participants with Change from Baseline in U-wave Morphology | The percentage of participants with change from baseline with abnormal U-waves morphology that represent the appearance or worsening of the morphological abnormality will be reported. | Baseline up to Day 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) | Cmax is the maximum observed plasma concentration of seltorexant and its circulating metabolites. | Pre-dose; 0.33, 0.5, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours Post-dose |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) |
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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 |
|---|---|---|---|---|---|---|
| Clinical Pharmacology Unit | Merksem | 2170 | Belgium |
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| Placebo Matched to Seltorexant | Other | Participants will be administered matching placebo to seltorexant tablets on Day 1. |
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| Placebo Matched to Moxifloxacin | Other | Participants will be administered oral dose of moxifloxacin placebo tablet on Day 1. |
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| Moxifloxacin Dose 1 | Drug | Participants will be administered oral dose 1 of moxifloxacin on Day 1. |
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Tmax is the time to reach the maximum observed plasma concentration of seltorexant and its circulating metabolites. |
| Pre-dose; 0.33, 0.5, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours Post-dose |
| Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Time (AUC [0-last]) | AUC(0-last) is the area under the plasma concentration-time curve from 0 to time of the last quantifiable concentration of seltorexant and its circulating metabolites. | Pre-dose; 0.33, 0.5, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours Post-dose |
| Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity]) | The AUC (0-infinity) is the area under the plasma concentration-time curve from time 0 to infinite time, calculated as the sum of AUC (0-last) and C(last)/lambda(z), in which AUC(0-last) is area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration, C(last) is the last observed quantifiable concentration and lambda(z) is elimination rate constant. AUC (0-infinity) will be assessed for seltorexant and its circulating metabolites. | Pre-dose; 0.33, 0.5, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours Post-dose |
| Elimination Half-Life (t1/2) | Elimination half-life associated with the terminal slope Lambda (z) of the semi logarithmic drug concentration-time curve, calculated as 0.693/Lambda (z). | Pre-dose; 0.33, 0.5, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours Post-dose |
| Total Apparent Clearance (CL/F) | CL/F for extravascular administration divided by the fraction of dose absorbed, calculated using the observed value of the last non-zero plasma concentration. | Pre-dose; 0.33, 0.5, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours Post-dose |
| Apparent Volume of Distribution (Vd/F) | Vd/F is defined as Dose/[Lambda (z)*AUC (0-infinity)]. | Pre-dose; 0.33, 0.5, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours Post-dose |
| Metabolite to Parent (M/P) Ratio for AUC[last] | M/P Ratio AUC[last] is the ratio of AUC[last] of seltorexant to AUC[last] of seltorexant's metabolites. | Pre-dose; 0.33, 0.5, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours Post-dose |
| Metabolite to Parent (M/P) Ratio for AUC[infinity] | M/P Ratio AUC[infinity] is the ratio of AUC[infinity] of seltorexant to AUC[infinity] of seltorexant's metabolites. | Pre-dose; 0.33, 0.5, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours Post-dose |
| Relationship Between the Plasma Concentrations of Seltorexant and Changes in the QT/QTc Interval | The relationship between change in QT/QTc interval and plasma concentrations from both doses of seltorexant at matching time points will be assessed. | Up to Day 3 |
| Number of Participants with Adverse Events and Serious Edverse Events as a Measure of Safety and Tolerability | An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. | Approximately 11 weeks |
| ID | Term |
|---|---|
| C000655226 | seltorexant |
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