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

NCT ID: NCT03438461

Last Updated: 2025-04-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-09
• Study Completion Date: 2018-05-30

Brief Summary

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Seltorexant 40 mg

Intervention Type: DRUG

Seltorexant 40 mg as two tablets of 20 mg will be administered as Formulation 1, 2 and 3 orally in Part 1.

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).

Group Type: EXPERIMENTAL

Seltorexant 20 mg

Intervention Type: DRUG

Seltorexant as a tablet of 20 mg will be administered as Formulation 1, 2 and 3 orally in Part 2.

Interventions

Seltorexant 40 mg

Seltorexant 40 mg as two tablets of 20 mg will be administered as Formulation 1, 2 and 3 orally in Part 1.

Intervention Type: DRUG

Seltorexant 20 mg

Seltorexant as a tablet of 20 mg will be administered as Formulation 1, 2 and 3 orally in Part 2.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

PRAHS

Salt Lake City, Utah, United States

Countries

United States

Other Identifiers

42847922MDD1004

Identifier Type: OTHER

Identifier Source: secondary_id

CR108446

Identifier Type: -

Identifier Source: org_study_id