PRA Health Sciences
Salt Lake City, Utah, 84124, United States
NCT Number: NCT04553042
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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Notify Me18 year–55 year
All sexes
Interventional
Phase 1
Salt Lake City, Utah, 84124, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Seltorexant will be administered orally as per assigned treatment sequence.
Other names: JNJ-42847922
Time frame: Predose, up to 48 hours post dose (Day 3)
Cmax is defined as the maximum observed plasma concentration of seltorexant and its metabolites.
Time frame: Predose, up to 48 hours post dose (Day 3)
Clast is defined as the last observed measurable (non-below quantification limit [non-BQL]) plasma concentration of seltorexant and its metabolites.
Time frame: Predose, up to 48 hours post dose (Day 3)
Tmax is defined as the actual sampling time to reach the maximum observed plasma concentration of seltorexant and its metabolites.
Time frame: Predose, up to 48 hours post dose (Day 3)
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.
Time frame: Predose, up to 48 hours post dose (Day 3)
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).
Time frame: Predose, up to 48 hours post dose (Day 3)
Apparent elimination half-life associated with the terminal slope lambda(z) of the semilogarithmic drug concentration-time curve of seltorexant and its metabolites.
Time frame: Up to 11 Weeks
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.
Time frame: Up to 11 Weeks
Number of participants with laboratory abnormalities related to hematology, serum chemistry, coagulation, and urinalysis will be reported.
Time frame: Up to 11 Weeks
Number of participants with clinically significant changes in vital signs including blood pressure, heart rate, respiratory rate, oral temperature will be reported.
Time frame: Up to 11 Weeks
Number of participants with abnormalities in ECG will be reported.
Time frame: Up to 11 Weeks
Number of participants with clinically significant changes in physical examination including height and body weight will be reported.
Janssen Research & Development, LLC
Industry
A Single-Dose, Open-Label, Randomized, Crossover Study to Assess the Bioequivalence Between Different Formulations and Phase 3 Formulation of Seltorexant Under Fasted Conditions in Healthy Participants
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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