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

An Open-Label, Single-Dose Study to Evaluate the Effect of Renal Impairment on the Pharmacokinetics of JNJ-42847922 in Adult Participants.

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.

Study Overview

• Status: Recruiting
• Conditions: Renal Impairment
• Intervention / Treatment: Drug: JNJ-42847922

• Study Type: Interventional
• Enrollment (Anticipated): 32
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Orlando, Florida, United States, 32809
      • Recruiting
      • Orlando Clinical Research Center
  • Tennessee
    • Knoxville, Tennessee, United States, 37923
      • Recruiting
      • AMR New Orleans, Formerly New Orleans Center for Clinical Research - New Orleans, an AMR company

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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
• Participants with normal renal function (Group 1) must meet the following additional inclusion criteria to be enrolled in the study: Must have normal renal function defined as: estimated glomerular filtration rate (eGFR) greater than or equal to (>=) 90 milliliter (mL)/minute (min) at screening
• Participants with moderate (optional Group 3) or severe (Group 2) renal impairment must meet the following additional inclusion criteria to be enrolled in the study: Must have a eGFR of less than (<) 90 mL/min with the following classification used at screening: Moderate renal impairment (eGFR >= 30 to 59 mL/min); Severe renal impairment (eGFR >= 15 to 29 mL/min)
• Participants with moderate (optional Group 3) or severe (Group 2) renal impairment must meet the following additional inclusion criteria to be enrolled in the study: Must have stable renal function, that is, no significant change in renal function as evidenced by the (mean) screening serum creatinine value within plus minus (+ -) 25 percent (%) from the determination obtained at least 3 months prior to screening, and expected to remain stable during the study, and not planning to initiate dialysis

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Parts 1 and 2: Cohort 1 (JNJ-42847922); 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; JNJ-42847922 tablet will be administered orally.; Other Names: Seltorexant
Experimental: Part 1: Cohort 2 (JNJ-42847922); 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; JNJ-42847922 tablet will be administered orally.; Other Names: Seltorexant
Experimental: Part 2 (Optional): Cohort 3 (JNJ-42847922); 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; JNJ-42847922 tablet will be administered orally.; Other Names: Seltorexant

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability	An AE can be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non investigational) product, whether or not related to that medicinal (investigational or non investigational) product.	Up to Day 5

Collaborators and Investigators

• Sponsor: Janssen Research & Development, LLC

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2021
• Primary Completion (Anticipated): December 12, 2022
• Study Completion (Anticipated): December 12, 2022

Study Registration Dates

• First Submitted: November 2, 2020
• First Submitted That Met QC Criteria: November 2, 2020
• First Posted (Actual): November 5, 2020

Study Record Updates

• Last Update Posted (Estimate): December 8, 2022
• Last Update Submitted That Met QC Criteria: December 6, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency
• Other Study ID Numbers: CR108903; 42847922MDD1014 (Other Identifier: Janssen Research & Development, LLC)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No