A Study to Evaluate the Relative Oral Bioavailability of Seltorexant (JNJ-42847922) After Administration of 3 Different Formulations in Healthy Participants Under Fasted and Semi-fasted Conditions

April 25, 2025 updated by: Janssen Research & Development, LLC

A Randomized, Open-label, Single-dose, 6-Period, 8-Sequence Crossover Study to Evaluate the Relative Oral Bioavailability of Seltorexant (JNJ-42847922) After Administration of 3 Different Formulations in Healthy Subjects Under Fasted and Semi-fasted Conditions

The purpose of this study is to assess and compare the pharmacokinetics (PK) and relative oral bioavailability of 3 oral tablet formulations of seltorexant in fasted and semi-fasted conditions.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

49

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Utah
      • Salt Lake City, Utah, United States, 84124
        • PRAHS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Have signed an informed consent form (ICF) indicating they understand the purpose of and procedures required for the study and are willing to participate in the study
  • Willing to adhere to the prohibitions and restrictions specified in the study protocol
  • If a woman 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 the first treatment period
  • If a woman, must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for at least 30 days 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 (example, vasectomy, double-barrier, partner using effective contraception) and to not donate sperm during the study and for 3 months after receiving the last dose of study drug

Exclusion Criteria:

  • Has a 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 determined at screening, thyroid disease, neurologic (including seizure disorders) or psychiatric disease, 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 gastrointestinal past history, or any disease/surgery (excluding cholecystectomy and appendectomy) that would interfere with drug absorption
  • Has clinically significant abnormal values for hematology, serum 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 both the investigator and to the Janssen Research & Development Safety Physician, are acceptable
  • Has clinically significant abnormal physical examination, vital signs, or 12 lead electrocardiogram (ECG) at screening or at admission to the study site as deemed appropriate by the investigator
  • Has used any prescription or nonprescription medication (including vitamins and herbal supplements), except for paracetamol (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 (example, St. John's Wort) from 21 days before the first dose of study drug is scheduled
  • Received a known inhibitor of CYP(cytochrome P450)3A4 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part 1
In Part 1, all participants will receive a single oral dose of seltorexant (40 milligram [mg]) in all the 6 treatments as Treatment A (Formulation 1 in fasted state), B (Formulation 1 in semi-fasted state), C (Formulation 2 in fasted state), D (Formulation 2 in semi-fasted state), E (Formulation 3 in fasted state) and F (Formulation 3 in semi-fasted state) and the participants will be assigned to one of the 8 sequences (that is, ADBCEF, ADBCFE, BACDEF, BACDFE, CBDAEF, CBDAFE, DCABEF, DCABFE). A washout period of at least 7 days between subsequent study drug administrations on Day 1 of each treatment period will be maintained.
Seltorexant 40 mg as two tablets of 20 mg will be administered as Formulation 1, 2 and 3 orally in Part 1.
Experimental: Part 2 (Optional)
Optional Part 2 will only be performed if considered to be warranted by the sponsor based on the preliminary pharmacokinetic (PK) analysis of the results from Part 1. Participants will receive a single oral dose of seltorexant (20 mg) as 3 different formulations assigned to one of the either 6 or 4 treatment sequences under fasted or semi-fasted conditions. The treatment will be assigned in 1 of the 6 or 4 assigned sequences per treatment period that is either Period 1 to 6 or Period 1 to 4).
Seltorexant as a tablet of 20 mg will be administered as Formulation 1, 2 and 3 orally in Part 2.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum Observed Plasma Concentration (Cmax) when Compared for 3 Oral Tablet Formulations of Seltorexant
Time Frame: Predose, 20 minutes (min), 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 20h (Day 1), 24h, 36h (Day 2), 48h (Day 3) postdose
Cmax is the maximum observed plasma concentration and will be evaluated when compared for 3 oral tablet formulations of seltorexant in fasted and semi-fasted conditions.
Predose, 20 minutes (min), 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 20h (Day 1), 24h, 36h (Day 2), 48h (Day 3) postdose
Area Under the Plasma Concentration-Time Curve from the Time of Study Drug Administration to the Last Measurable Plasma Concentration (AUC[0-last]) when Compared for 3 Oral Tablet Formulations of Seltorexant
Time Frame: Predose, 20 minutes (min), 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 20h (Day 1), 24h, 36h (Day 2), 48h (Day 3) postdose
AUC (0-last) is the area under the plasma concentration-time curve from the time of study drug administration to the last measurable plasma concentration and will be evaluated when compared for 3 oral tablet formulations of seltorexant in fasted and semi-fasted conditions.
Predose, 20 minutes (min), 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 20h (Day 1), 24h, 36h (Day 2), 48h (Day 3) postdose
Area Under the Plasma Concentration-Time Curve Extrapolated to Infinite Time (AUC[0-infinity]) when Compared for 3 Oral Tablet Formulations of Seltorexant
Time Frame: Predose, 20 minutes (min), 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 20h (Day 1), 24h, 36h (Day 2), 48h (Day 3) postdose
AUC (0-infinity) is the 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 and will be evaluated when compared for 3 oral tablet formulations of seltorexant in fasted and semi-fasted conditions.
Predose, 20 minutes (min), 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 20h (Day 1), 24h, 36h (Day 2), 48h (Day 3) postdose
Relative Bioavailability of Seltorexant when Compared for 3 Oral Tablet Formulations of Seltorexant
Time Frame: Predose, 20 minutes (min), 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 20h (Day 1), 24h, 36h (Day 2), 48h (Day 3) postdose
Relative bioavailability is the percentage of the administered dose that is systemically available, calculated as: (AUC [0-infinity] of test divided by AUC [0-infinity] of reference) multiplied by 100, where the reference treatment is a non-intravenous administration. Relative bioavailability will be evaluated when compared for 3 oral tablet formulations of seltorexant in fasted and semi-fasted conditions.
Predose, 20 minutes (min), 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 20h (Day 1), 24h, 36h (Day 2), 48h (Day 3) postdose

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cmax when Compared Between Fasted and Semi-Fasted Conditions
Time Frame: Predose, 20 minutes (min), 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 20h (Day 1), 24h, 36h (Day 2), 48h (Day 3) postdose
Cmax when compared between fasted and semi-fasted conditions will be evaluated for the 3 oral tablet formulations of seltorexant.
Predose, 20 minutes (min), 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 20h (Day 1), 24h, 36h (Day 2), 48h (Day 3) postdose
AUC (0-last) when Compared Between Fasted and Semi-Fasted Conditions
Time Frame: Predose, 20 minutes (min), 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 20h (Day 1), 24h, 36h (Day 2), 48h (Day 3) postdose
AUC (0-last) when compared between fasted and semi-fasted conditions will be evaluated for the 3 oral tablet formulations of seltorexant.
Predose, 20 minutes (min), 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 20h (Day 1), 24h, 36h (Day 2), 48h (Day 3) postdose
AUC (0-infinity) when Compared Between Fasted and Semi-Fasted Conditions
Time Frame: Predose, 20 minutes (min), 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 20h (Day 1), 24h, 36h (Day 2), 48h (Day 3) postdose
AUC (0-infinity) when compared between fasted and semi-fasted conditions will be evaluated for the 3 oral tablet formulations of seltorexant.
Predose, 20 minutes (min), 30min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 20h (Day 1), 24h, 36h (Day 2), 48h (Day 3) postdose
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time Frame: From Screening till End-of- Study (up to approximately 18 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.
From Screening till End-of- Study (up to approximately 18 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 9, 2018

Primary Completion (Actual)

May 30, 2018

Study Completion (Actual)

May 30, 2018

Study Registration Dates

First Submitted

February 8, 2018

First Submitted That Met QC Criteria

February 16, 2018

First Posted (Actual)

February 19, 2018

Study Record Updates

Last Update Posted (Actual)

April 27, 2025

Last Update Submitted That Met QC Criteria

April 25, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • CR108446
  • 42847922MDD1004 (Other Identifier: Janssen Research & Development, LLC)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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