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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-31

Study Completion Date

2022-10-18

Brief Summary

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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.

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Detailed Description

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Conditions

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Renal Impairment

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

JNJ-42847922

Intervention Type DRUG

JNJ-42847922 tablet will be administered orally.

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.

Group Type EXPERIMENTAL

JNJ-42847922

Intervention Type DRUG

JNJ-42847922 tablet will be administered orally.

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.

Group Type EXPERIMENTAL

JNJ-42847922

Intervention Type DRUG

JNJ-42847922 tablet will be administered orally.

Interventions

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JNJ-42847922

JNJ-42847922 tablet will be administered orally.

Intervention Type DRUG

Other Intervention Names

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Seltorexant

Eligibility Criteria

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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

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes