Clinical trial NCT04553042: A Study of Seltorexant in Healthy Participants
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2020-09-17
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


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 of Treatment Period 1 or prior to randomization
* Be healthy on the basis of clinical laboratory tests performed at screening
* 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
* Body mass index (BMI) between 18.0 and 30.0 kilogram per meter square (kg/m\^2, inclusive (BMI = weight/height\^2), and body weight not less than 50 kilogram (kg)
* Blood pressure (after the participant is supine for 5 minutes) between 90 and 140 millimeter of Mercury (mmHg) systolic, inclusive, and no higher than 90 mmHg diastolic

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 or renal insufficiency (estimated glomerular filtration rate \[eGFR\] less than (\<) 80 milliliter per minute (mL/min)/1.73 per meter square (m\^2) at screening only), thyroid disease, neurologic (including seizure disorders) or psychiatric disease (depression or anxiety disorder in remission and no longer requiring medication 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
* Has any significant or is suspected to have a primary sleep disorder, including but not limited to obstructive sleep apnea, restless leg syndrome, or parasomnias based on history and/or physical exam. Participants with insomnia disorder are allowed if not requiring medication
* 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
* Known allergies, hypersensitivity, or intolerance to seltorexant or its excipients
* Positive test for human immunodeficiency virus (HIV)-1 and HIV-2 antibodies, hepatitis B surface antigen (HbsAg), or hepatitis C antibodies at screening

Primary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax) of Seltorexant and its Metabolites
timeFrame: Predose, up to 48 hours post dose (Day 3)
measure: Last Observed Measurable Plasma Concentration (Clast) of Seltorexant and its Metabolites
timeFrame: Predose, up to 48 hours post dose (Day 3)
measure: Time to Reach the Maximum Observed Plasma Concentration (Tmax) of Seltorexant and its Metabolites
timeFrame: Predose, up to 48 hours post dose (Day 3)
measure: 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
timeFrame: Predose, up to 48 hours post dose (Day 3)
measure: Area Under the Plasma Concentration-time Curve from Time Zero to Infinity (AUC [0-infinity]) of Seltorexant and its Metabolites
timeFrame: Predose, up to 48 hours post dose (Day 3)
measure: Apparent Terminal Elimination Half-life (t1/2) of Seltorexant and its Metabolites
timeFrame: Predose, up to 48 hours post dose (Day 3)
Secondary outcomes:
measure: Number of Participants with Adverse Events (AEs) including AEs of Special Interest (AESI) as a Measure of Safety and Tolerability
timeFrame: Up to 11 Weeks
measure: Number of Participants with Laboratory Abnormalities
timeFrame: Up to 11 Weeks
measure: Number of Participants with Clinically Significant Changes in Vital Signs
timeFrame: Up to 11 Weeks
measure: Number of Participants with Abnormalities in Electrocardiogram (ECG)
timeFrame: Up to 11 Weeks
measure: Number of Participants with Clinically Significant Changes in Physical Examination
timeFrame: Up to 11 Weeks
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: PRA Health Sciences
state: Utah
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: