PRAHS
Salt Lake City, Utah, 84124, United States
NCT Number: NCT03682380
The purpose of this study is to compare the rate and extent of absorption (relative bioavailability) of seltorexant Phase 3 test formulation(s) relative to a reference Phase 2b tablet formulation dosed in the evening under fasted and semi-fasted conditions (3 hours after meal); to assess the effect of type and timing of the meal on the rate and extent of absorption of seltorexant Phase 3 tablet formulation (low dose and high dose strength) in healthy male and female participants; and to assess the pharmacokinetic of single-dose administration of low dose and high dose of seltorexant in healthy male and female participants 3 hours after meal.
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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
In Part 1, Part 2, and Part 3 (3A and 3C), Seltorexant high dose (either a high dose tablet or two low dose tablets) will be administered orally.
Other names: MIN-202, JNJ-42847922
In Part 3 (3B and 3C), Seltorexant low dose will be administered orally.
Other names: MIN-202, JNJ-42847922
Time frame: Predose up to 48 hours postdose
Cmax is the maximum observed plasma concentration.
Time frame: Predose up to 48 hours postdose
AUC(0-last) is the area under the plasma concentration-time curve from the time of dosing to the last measurable plasma concentration.
Time frame: Predose, up to 48 hours postdose
AUC (0-infinity) 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.
Time frame: Part 1: approximately 16 weeks; Part 2: approximately 10 weeks; Part 3: approximately 39 weeks
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.
Time frame: Predose up to 48 hours postdose
Dose proportionality of single doses of low dose and high dose of seltorexant from the Cmax will be assessed.
Time frame: Predose up to 48 hours postdose
Dose proportionality of single doses of low dose and high dose of seltorexant from the AUC(0-last) will be assessed.
Time frame: Predose up to 48 hours postdose
Dose proportionality of single doses of low dose and high dose of seltorexant from the AUC(0-infinity) will be assessed.
Time frame: Predose up to 12 hours postdose
Plasma protein binding (PPB) of seltorexant and its metabolites (M12 and M16) will be determined by using a qualified liquid chromatography coupled with tandem mass spectrometry (LC-MS/MS) method.
Time frame: Baseline, Day 1, and Day 2
The KSS is a self reported, assessment of level of drowsiness at the time of scale administration. This scale is focused mainly on the propensity to fall asleep and has a high validity in measuring sleepiness. It consists of a 9-point Likert scale with response options from: 1=extremely alert, 2=very alert, 3=alert, 4=rather alert, 5=neither alert nor sleepy, 6= some signs of sleepiness, 7=sleepy (but no effort to keep awake), 8= sleepy, some effort to keep awake , 9=very sleepy (fighting sleep).
Janssen Research & Development, LLC
Industry
An Open-Label, Randomized, Multi-panel, Crossover Study to Evaluate the Relative Oral Bioavailability and Food Effect of Seltorexant (JNJ-42847922) After Single-Dose Administration in Healthy Subjects
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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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