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

Phase 1

Completed

• Conditions: Renal Impairment
• Interventions: Drug: JNJ-42847922

• Registration Number: NCT04616677
• Lead Sponsor: Janssen Research & Development, LLC

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-11-02
• Study First Submitted QC: 2020-11-02
• Study First Posted: 2020-11-05
• Study Start: 2021-03-31
• Primary Completion: 2022-10-18
• Study Completion: 2022-10-18
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-25
• Last Update Posted: 2025-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Parts 1 and 2: Cohort 1 (JNJ-42847922)	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.
Part 1: Cohort 2 (JNJ-42847922)	JNJ-42847922	Participants with severe renal impairment (eGFR 15 to 29 mL/min) will receive single oral dose of JNJ-42847922 on Day 1.
Part 2 (Optional): Cohort 3 (JNJ-42847922)	JNJ-42847922	Participants with moderate renal impairment (eGFR 30 to 59 mL/min) will receive single oral dose of JNJ-42847922 on Day 1.

Primary Outcome Measures

Name	Time	Method
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	Pre-dose, up to 96 hours post-dose (up to Day 5)	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.
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	Pre-dose, up to 96 hours post-dose (up to Day 5)	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.
Maximum Observed Plasma Analyte Concentration (Cmax) of JNJ-42847922 and its Metabolites A and B	Pre-dose, up to 96 hours post-dose (up to Day 5)	Cmax is defined as maximum observed plasma analyte concentration of JNJ-42847922 and its metabolites A and B.

Secondary Outcome Measures

Name	Time	Method
Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability	Up to Day 5	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.

Trial Locations

Locations (2)

Orlando Clinical Research Center; 🇺🇸 Orlando, Florida, United States

AMR New Orleans, Formerly New Orleans Center for Clinical Research - New Orleans, an AMR company; 🇺🇸 Knoxville, Tennessee, United States