A Study to Evaluate the Effect of Renal Impairment on JNJ-42847922 in Adult Participants

NCT04616677 | Completed Phase 1 FDA Drug

• 2 other identifiers: CR10890342847922MDD1014
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to evaluate the pharmacokinetic of a single oral dose of JNJ-42847922 in adult participants with renal impairment compared with healthy participants with normal renal function.

Conditions

Renal Impairment

Outcome Measures

Primary Outcomes (3)

• Maximum Observed Plasma Analyte Concentration (Cmax) of JNJ-42847922 and its Metabolites A and B

  Cmax is defined as maximum observed plasma analyte concentration of JNJ-42847922 and its metabolites A and B.

  Pre-dose, up to 96 hours post-dose (up to Day 5)

• Area Under Plasma Analyte Concentration versus Time Curve from Time 0 to Time of Last Measurable Concentration (AUC [0-Last]) of JNJ-42847922 and its Metabolites A and B

  AUC(0-Last) is defined as area under the plasma analyte concentration versus time curve from time 0 to time of last measurable concentration of JNJ-42847922 and its metabolites A and B.

  Pre-dose, up to 96 hours post-dose (up to Day 5)

• Area Under the Plasma Analyte Concentration versus Time Curve from Time 0 to Infinite Time (AUC[0-Infinity]) of JNJ-42847922 and its Metabolites A and B

  AUC(0-infinity) is defined as the area under the plasma analyte concentration versus time curve from time 0 to infinite time of JNJ-42847922 and its metabolites A and B.

  Pre-dose, up to 96 hours post-dose (up to Day 5)

Secondary Outcomes (1)

• Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability

  Up to Day 5

Study Arms (3)

Parts 1 and 2: Cohort 1 (JNJ-42847922)

ACTIVE COMPARATOR

Healthy participants with normal renal function \[estimated glomerular filtration rate (eGFR) greater than or equal to (\>=) 90 milliliter (mL)/minute (min)\] will receive single oral dose of JNJ-42847922 on Day 1.

Drug: JNJ-42847922

Part 1: Cohort 2 (JNJ-42847922)

EXPERIMENTAL

Participants with severe renal impairment (eGFR 15 to 29 mL/min) will receive single oral dose of JNJ-42847922 on Day 1.

Drug: JNJ-42847922

Part 2 (Optional): Cohort 3 (JNJ-42847922)

EXPERIMENTAL

Participants with moderate renal impairment (eGFR 30 to 59 mL/min) will receive single oral dose of JNJ-42847922 on Day 1.

Drug: JNJ-42847922

Interventions

JNJ-42847922 DRUG

JNJ-42847922 tablet will be administered orally.

Also known as: Seltorexant

Part 1: Cohort 2 (JNJ-42847922); Part 2 (Optional): Cohort 3 (JNJ-42847922); Parts 1 and 2: Cohort 1 (JNJ-42847922)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Body mass index (BMI; weight \[kilogram {kg}\]/height \[meter {m}\]\^2) between 18 and 40 kilograms per meter square (kg/m\^2) (inclusive) with a body weight not less than 50 kg
• All female participants (regardless of childbearing potential), must have a negative serum beta-human chorionic gonadotropin (hCG) pregnancy test at screening and a negative urine pregnancy test on Day 1
• Must not donate blood for up to 3 months after study

You may not qualify if:

• Participants who: are on a vegetarian diet or who take creatine supplements, have a non-standard muscle mass, such as, amputation, malnutrition, or muscle wasting, because these factors are not accounted for in the prediction equations for glomerular filtration rate (GFR)
• Donated blood or blood products or had substantial loss of blood (more than 500 mL) within 3 months before the first administration of study drug or intention to donate blood or blood products during the study
• Received an experimental drug or used an experimental medical device within 1 month or within a period less than 5 times the drug's half-life, whichever is longer, before study drug is scheduled
• Unable to swallow solid, oral dosage forms whole with the aid of water (participants may not chew, divide, dissolve, or crush the study drug)
• Participants with renal impairment (Cohort 2 and Cohort 3) have kidney failure, requiring dialysis

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (2)

Orlando Clinical Research Center

Orlando, Florida, 32809, United States

Location

AMR New Orleans, Formerly New Orleans Center for Clinical Research - New Orleans, an AMR company

Knoxville, Tennessee, 37923, United States

Location

MeSH Terms

Conditions

Renal Insufficiency

Interventions

seltorexant

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2020
• First Posted: November 5, 2020
• Study Start: March 31, 2021
• Primary Completion: October 18, 2022
• Study Completion: October 18, 2022
• Last Updated: April 27, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share

Locations

US (2)