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

Renal Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04616677
• Other study ID #: CR108903
• Secondary ID: 42847922MDD1014
• Status: Completed
• Phase: Phase 1
• Start date: March 31, 2021
• Est. completion date: October 18, 2022

Study information

• Verified date: February 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: October 18, 2022
• Est. primary completion date: October 18, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Renal Impairment
• Renal Insufficiency

Intervention

Drug:
• JNJ-42847922
JNJ-42847922 tablet will be administered orally.

Locations

Country	Name	City	State
United States	AMR New Orleans, Formerly New Orleans Center for Clinical Research - New Orleans, an AMR company	Knoxville	Tennessee
United States	Orlando Clinical Research Center	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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	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