A Study of Seltorexant in Healthy Participants

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04553042
• Other study ID #: CR108883
• Secondary ID: 42847922MDD1018
• Status: Completed
• Phase: Phase 1
• Start date: September 14, 2020
• Est. completion date: December 30, 2020

Study information

• Verified date: April 2021
• Source: Janssen Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: December 30, 2020
• Est. primary completion date: December 20, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Seltorexant
Seltorexant will be administered orally as per assigned treatment sequence.

Locations

Country	Name	City	State
United States	PRA Health Sciences	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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	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
Secondary	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
Secondary	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
Secondary	Number of Participants with Abnormalities in Electrocardiogram (ECG)	Number of participants with abnormalities in ECG will be reported.	Up to 11 Weeks
Secondary	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

External Links

•   To learn how to participate in this trial please click here.