A Study of JNJ-42847922 (Seltorexant) in Healthy Participants

Healthy Clinical Trial

Official title:

An Open-Label, Single-Dose Study to Assess the Absolute Oral Bioavailability and Pharmacokinetics of JNJ-42847922 (Seltorexant) Administered as Oral Tablet and an Intravenous Microdose of 14C-seltorexant in Healthy Participants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05236868
• Other study ID #: CR109133
• Secondary ID: 42847922MDD10192
• Status: Completed
• Phase: Phase 1
• Start date: February 3, 2022
• Est. completion date: March 1, 2022

Study information

• Verified date: March 2023
• 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 determine the absolute bioavailability of seltorexant in healthy participants following a single oral dose of seltorexant and an intravenous (IV) infusion dose of 14C-seltorexant.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: March 1, 2022
• Est. primary completion date: March 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Healthy on the basis of medical history at screening and physical examination, vital signs, and 12-lead electrocardiogram (ECG) performed at screening and at admission to the study site on Day 1

• Healthy on the basis of clinical laboratory tests performed at screening and at admission to the study site on Day -1

• 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

• A woman must be a) Not of childbearing potential; b) Of childbearing potential and practicing a highly effective method of contraception (failure rate of less than (<) 1 percent (%) per year when used consistently and correctly) and agrees to remain on a highly effective method while receiving study intervention and until 3 months after the study treatment administration

• Must sign an informed consent form (ICF) indicating that the participant understands the purpose of, and procedures required for, the study and is willing to participate in the study

Exclusion Criteria:

• Clinically significant abnormal values for hematology, clinical chemistry, or urinalysis at screening or at admission to the study site (Day -1) as determined by the investigator. Alanine transaminase (ALT)/aspartate transaminase (AST) concentrations within normal range at screening. One retest for ALT/AST is permitted

• Clinically significant abnormal physical examination, vital signs, or 12-lead (ECG) at screening or at admission to the study site on Day -1 as determined by the investigator

• Participant has a current or recent history of serious suicidal ideation within the past 6 months, corresponding to a positive response on item 4 (active suicidal ideation with some intent to act, without specific plan) or item 5 (active suicidal ideation with specific plan and intent) for ideation on the Columbia-Suicide Severity Rating Scale (C SSRS), or a lifetime history of suicidal behavior or suicidal attempt as validated by the C SSRS at screening

• Positive test for human immunodeficiency virus (HIV)-1 and HIV-2 antibodies, hepatitis B surface antigen (HBsAg), or hepatitis C antibodies

• Has any history or current diagnosis of obstructive sleep apnea or parasomnias. Participants with restless leg syndrome/periodic leg movement disorder or insomnia disorder are allowed if not requiring medication

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Seltorexant
Seltorexant will be administered orally as a tablet and as an intravenous infusion of 14C-seltorexant.

Locations

Country	Name	City	State
Netherlands	PRA Health Sciences Onderzoekscentrum Groningen, locatie Martini	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absolute Bioavailability	Absolute bioavailability is calculated as the ratio of dose normalized area under the plasma drug concentration-time curve (AUC) of oral and intravenous (IV) administration.	Up to Day 4
Secondary	Area Under the Plasma Analyte Concentration Versus Time Curve of Seltorexant from Time Zero to Infinite time (AUC [0-Infinity])	AUC (0-infinity) is defined as the area under the plasma analyte concentration versus time curve of seltorexant from time zero to infinite time.	Up to Day 4
Secondary	Area Under the Plasma Analyte Concentration Versus Time Curve of Seltorexant from Time Zero to Time of the Last Measurable Concentration (AUC [0-Last])	AUC (0-Last) is defined as area under the plasma analyte concentration versus time curve from time zero to time of the last measurable (non- below quantifiable limit [BQL]) concentration.	Up to Day 4
Secondary	Maximum Observed Plasma Analyte Concentration (Cmax) of Seltorexant	Cmax of Seltorexant will be reported.	Up to Day 4
Secondary	Time to Reach Maximum Observed Plasma Concentration (Tmax) of Seltorexant	Tmax of Seltorexant will be reported.	Up to Day 4
Secondary	Apparent Terminal Elimination Half-life (t1/2) of Seltorexant	Apparent terminal elimination half-life is calculated as 0.693/ lambda(z).	Up to Day 4
Secondary	Number of Participants with Adverse Events (AEs)	An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.	Screening (up to -21 days) up to Day 7