Clinical trial NCT04616677: A Study to Evaluate the Effect of Renal Impairment on JNJ-42847922 in Adult Participants
Official title: An Open-Label, Single-Dose Study to Evaluate the Effect of Renal Impairment on the Pharmacokinetics of JNJ-42847922 in Adult Participants.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Renal Impairment
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2020-11-05
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Maximum Observed Plasma Analyte Concentration (Cmax) of JNJ-42847922 and its Metabolites A and B
timeFrame: Pre-dose, up to 96 hours post-dose (up to Day 5)
measure: 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
timeFrame: Pre-dose, up to 96 hours post-dose (up to Day 5)
measure: 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
timeFrame: Pre-dose, up to 96 hours post-dose (up to Day 5)
Secondary outcomes:
measure: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
timeFrame: Up to Day 5
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Orlando Clinical Research Center
state: Florida
city: Knoxville
country: United States
facility: AMR New Orleans, Formerly New Orleans Center for Clinical Research - New Orleans, an AMR company
state: Tennessee
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: