Clinical trial NCT03682380: A Study of Seltorexant (JNJ-42847922) After Single-Dose Administration in Healthy Participants
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2018-09-24
Enrollment: 151
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Be healthy on the basis of medical history (screening only), physical examination, vital signs, and 12-lead electrocardiogram (ECG) performed at screening and Day 1 (predose)
* Be healthy on the basis of clinical laboratory tests performed at screening. If the results of the serum chemistry panel, hematology, or urinalysis are outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant. This determination must be recorded in the participant's source documents and initialed by the investigator
* All female participants (regardless of childbearing potential), must have a negative serum beta-human chorionic gonadotropin (beta-hCG) pregnancy test at screening and a negative urine pregnancy test on Day -1 of each treatment period
* A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for at least 1 month after the last study drug administration
* A man, who is sexually active with a woman of childbearing potential and has not had a vasectomy, must agree to use an adequate contraception method as deemed appropriate by the investigator (for example, abstinence, vasectomy, barrier method, partner using effective contraception)

Exclusion Criteria:

* History of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders (including any abnormal bleeding or blood dyscrasias), lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, hepatic (Child-Pugh Score greater than or equal to \[\>=\] 7) or renal insufficiency (estimated glomerular filtration rate \[eGFR\] less than \[\<\] 60 milliliter per minute per 1.73 meter square \[mL/min/1.73m\^2\] based on the modified diet renal disease \[MDRD\] formula at screening only), thyroid disease, neurologic (including seizure disorders) or psychiatric disease (depression or anxiety disorder in remission is acceptable), infection, or any other illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results. Significant past gastrointestinal medical history, or any disease/surgery that would with interfere drug absorption
* Clinically significant abnormal values for hematology, clinical chemistry (including thyroid stimulating hormone \[TSH\] at screening only) or urinalysis at screening or at admission to the study site. It is expected that laboratory values will generally be within the normal range for the laboratory, though minor deviations, which are not considered to be of clinical significance to the investigator, are acceptable
* Clinically significant abnormal physical examination, vital signs, or 12-lead ECG at screening or at admission to the study site though minor deviations, which are not considered to be of clinical significance to the investigator are acceptable
* Use of any prescription or nonprescription medication (including vitamins and herbal supplements), except for acetaminophen, oral contraceptives, and hormonal replacement therapy within 14 days before the first dose of the study drug is scheduled. Or has used any systemic herbal medications or dietary supplements including products containing Hypericum perforatum (for example, St. John's Wort) from 21 days before the first dose of study drug is scheduled
* Received a known inhibitor of Cytochrome P450 3A4 (CYP3A4) or CYP2C9 activity within 14 days or a period less than 5 times the drugs half-life; whichever is longer, before the first dose of the study drug is scheduled

Primary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: Predose up to 48 hours postdose
measure: Area Under the Plasma Concentration-Time Curve from the Time of Dosing to the Last Measurable Plasma Concentration (AUC[0-last])
timeFrame: Predose up to 48 hours postdose
measure: Area Under the Plasma Concentration-Time Curve Extrapolated to Infinite Time (AUC[0-infinity])
timeFrame: Predose, up to 48 hours postdose
Secondary outcomes:
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: Part 1: approximately 16 weeks; Part 2: approximately 10 weeks; Part 3: approximately 39 weeks
measure: Dose-Proportionality of Seltorexant Based on Cmax
timeFrame: Predose up to 48 hours postdose
measure: Dose-Proportionality of Seltorexant Based on AUC(0-last)
timeFrame: Predose up to 48 hours postdose
measure: Dose-Proportionality of Seltorexant Based on AUC(0-infinity)
timeFrame: Predose up to 48 hours postdose
measure: Plasma Protein Binding (PPB) of Seltorexant and Its Metabolites (M12 and M16)
timeFrame: Predose up to 12 hours postdose
measure: Change from Baseline in Karolinska Sleepiness Scale (KSS) Score
timeFrame: Baseline, Day 1, and Day 2
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: PRAHS
state: Utah
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: