A Study of Seltorexant in Healthy Participants

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Seltorexant

• Study Type: Interventional
• Enrollment (Actual): 69
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84124
      • PRA Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Sequence ABC; Participants will receive a single dose of seltorexant as formulation (Test 1) (Treatment A) in Treatment Period 1, followed by a single dose of seltorexant as formulation (Test 2) (Treatment B) in Treatment Period 2, followed by a single dose of seltorexant as formulation (Reference) (Treatment C) in Treatment Period 3 on Day 1 of each Treatment Period under fasted condition. There will be a washout period of 7 to 14 days from dosing on Day 1 of each Treatment Period.	Drug: Seltorexant; Seltorexant will be administered orally as per assigned treatment sequence.; Other Names: JNJ-42847922
Experimental: Treatment Sequence BCA; Participants will receive Treatment B in Treatment Period 1, followed by Treatment C in Treatment Period 2, followed by Treatment A in Treatment Period 3 on Day 1 of each Treatment Period under fasted condition. There will be a washout period of 7 to 14 days from dosing on Day 1 of each Treatment Period.	Drug: Seltorexant; Seltorexant will be administered orally as per assigned treatment sequence.; Other Names: JNJ-42847922
Experimental: Treatment Sequence CAB; Participants will receive Treatment C in Treatment Period 1, followed by Treatment A in Treatment Period 2, followed by Treatment B in Treatment Period 3 on Day 1 of each Treatment Period under fasted condition. There will be a washout period of 7 to 14 days from dosing on Day 1 of each Treatment Period.	Drug: Seltorexant; Seltorexant will be administered orally as per assigned treatment sequence.; Other Names: JNJ-42847922
Experimental: Treatment Sequence CBA; Participants will receive Treatment C in Treatment Period 1, followed by Treatment B in Treatment Period 2, followed by Treatment A in Treatment Period 3 on Day 1 of each Treatment Period under fasted condition. There will be a washout period of 7 to 14 days from dosing on Day 1 of each Treatment Period.	Drug: Seltorexant; Seltorexant will be administered orally as per assigned treatment sequence.; Other Names: JNJ-42847922
Experimental: Treatment Sequence ACB; Participants will receive Treatment A in Treatment Period 1, followed by Treatment C in Treatment Period 2, followed by Treatment B in Treatment Period 3 on Day 1 of each Treatment Period under fasted condition. There will be a washout period of 7 to 14 days from dosing on Day 1 of each Treatment Period.	Drug: Seltorexant; Seltorexant will be administered orally as per assigned treatment sequence.; Other Names: JNJ-42847922
Experimental: Treatment Sequence BAC; Participants will receive Treatment B in Treatment Period 1, followed by Treatment A in Treatment Period 2, followed by Treatment C in Treatment Period 3 on Day 1 of each Treatment Period under fasted condition. There will be a washout period of 7 to 14 days from dosing on Day 1 of each Treatment Period.	Drug: Seltorexant; Seltorexant will be administered orally as per assigned treatment sequence.; Other Names: JNJ-42847922

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum Observed Plasma Concentration (Cmax) of Seltorexant and its Metabolites	Cmax is defined as the maximum observed plasma concentration of seltorexant and its metabolites.	Predose, up to 48 hours post dose (Day 3)
Last Observed Measurable Plasma Concentration (Clast) of Seltorexant and its Metabolites	Clast is defined as the last observed measurable (non-below quantification limit [non-BQL]) plasma concentration of seltorexant and its metabolites.	Predose, up to 48 hours post dose (Day 3)
Time to Reach the Maximum Observed Plasma Concentration (Tmax) of Seltorexant and its Metabolites	Tmax is defined as the actual sampling time to reach the maximum observed plasma concentration of seltorexant and its metabolites.	Predose, up to 48 hours post dose (Day 3)
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	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.	Predose, up to 48 hours post dose (Day 3)
Area Under the Plasma Concentration-time Curve from Time Zero to Infinity (AUC [0-infinity]) of Seltorexant and its Metabolites	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).	Predose, up to 48 hours post dose (Day 3)
Apparent Terminal Elimination Half-life (t1/2) of Seltorexant and its Metabolites	Apparent elimination half-life associated with the terminal slope lambda(z) of the semilogarithmic drug concentration-time curve of seltorexant and its metabolites.	Predose, up to 48 hours post dose (Day 3)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Adverse Events (AEs) including AEs of Special Interest (AESI) as a Measure of Safety and Tolerability	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.	Up to 11 Weeks
Number of Participants with Laboratory Abnormalities	Number of participants with laboratory abnormalities related to hematology, serum chemistry, coagulation, and urinalysis will be reported.	Up to 11 Weeks
Number of Participants with Clinically Significant Changes in Vital Signs	Number of participants with clinically significant changes in vital signs including blood pressure, heart rate, respiratory rate, oral temperature will be reported.	Up to 11 Weeks
Number of Participants with Abnormalities in Electrocardiogram (ECG)	Number of participants with abnormalities in ECG will be reported.	Up to 11 Weeks
Number of Participants with Clinically Significant Changes in Physical Examination	Number of participants with clinically significant changes in physical examination including height and body weight will be reported.	Up to 11 Weeks

Collaborators and Investigators

• Sponsor: Janssen Research & Development, LLC

Study record dates

Study Major Dates

• Study Start (Actual): September 14, 2020
• Primary Completion (Actual): December 20, 2020
• Study Completion (Actual): December 30, 2020

Study Registration Dates

• First Submitted: September 14, 2020
• First Submitted That Met QC Criteria: September 14, 2020
• First Posted (Actual): September 17, 2020

Study Record Updates

• Last Update Posted (Actual): April 26, 2021
• Last Update Submitted That Met QC Criteria: April 22, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: CR108883; 42847922MDD1018 (Other Identifier: Janssen Research & Development, LLC)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No