Clinical trial NCT04474210: A Study to Evaluate the Effect of Renal Impairment on JNJ-56136379 in Adult Participants
Official title: An Open-Label, Single-Dose Study to Evaluate the Effect of Renal Impairment on the Pharmacokinetics of JNJ-56136379 in Adult Participants
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Renal Insufficiency
Keywords: Renal Impairment
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2020-07-16
Enrollment: 1
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: OTHER

Brief summary: The purpose of this study is to evaluate the pharmacokinetics (PK) of a single oral dose of JNJ-56136379 in adult participants with renal impairment compared with healthy participants with normal renal function.


Eligibility criteria: Inclusion Criteria:

- Body mass index (BMI) (kilograms \[kg\]/height \[m\]\^2) between 18.0 and 38.0 kilogram/meter\^2 (kg/m2) (inclusive), and body weight not less than (\<) 50 kg

Participants with normal renal function:

* Have normal renal function defined as estimated glomerular filtration rate (eGFR) greater than or equal to (\>=) 90 milliliter/minute computed with the online calculator on the CKD-EPI website by use of the Chronic Kidney Disease Epidemiology Collaboration creatinine clearance (CKD-EPIcr) result
* Must have stable renal function as defined as: (a) for participants with impaired renal function: \<20 percent (%) change in serum creatinine concentrations between screening and Day -1; (b) for healthy participants: a change in serum creatinine concentration \<0.2 milligram per deciliter (mg/dL) between screening and Day -1

Participants with renal impairment:

* Have an impaired renal function based on eGFR as(eGFR computed with the online calculator on the CKD-EPI website providing eGFR (in mL/min units) by use of the CKD-EPIcr result: (a) eGFR \<90 to 60 mL/minute for participants in Group 3 (mild renal impairment cohort); (b) eGFR 30 to 59 mL/minute for participants in Group 4 (moderate renal impairment cohort); (c) eGFR \<30 mL/minute but not yet on hemodialysis, for participants in Group 1 (severe renal impairment and/or kidney failure); (d) eGFR \<15 mL/minute and on hemodialysis, for participants in Group 5 (kidney failure)
* Concomitant medications to treat underlying disease states or medical conditions related to renal impairment are allowed. Participants must be on a stable dose of medication and/or treatment regimen for at least 2 months (3 months for thyroid hormone replacement therapy \[HRT\]) before dosing as well as during the study

Exclusion Criteria:

- Individuals 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 GFR chronic kidney disease epidemiology collaboration (CKD EPI)

Participants with normal renal function:

* Clinically significant abnormal values for hematology, clinical chemistry, or urinalysis at screening or Day -1, as deemed appropriate by the investigator
* Clinically significant abnormal physical examination, vital signs, body temperature, or 12 lead ECG at screening or Day -1, as deemed appropriate by the investigator

Participants with renal impairment:

* Evidence of clinically apparent concurrent disease based upon complete clinical laboratory testing, full physical examination, or medical history, except for controlled hypertension and those problems directly associated with the primary diagnosis of renal impairment
* Any clinically significant laboratory abnormality except abnormalities that may be caused by renal impairment

Primary outcomes:
measure: Maximum Observed Plasma Analyte Concentration (Cmax)
timeFrame: Up to Day 29
measure: Time to Reach the Maximum Observed Plasma Analyte Concentration (Tmax)
timeFrame: Up to Day 29
measure: Area Under the Analyte Concentration-time Curve From Time Zero to 24 Hours Postdose (AUC [0-24])
timeFrame: Up to 24 hours postdose
measure: Area Under the Analyte Concentration-time Curve From Time Zero to 144 Hours Postdose (AUC [0-144])
timeFrame: Up to 144 hours postdose
measure: Area Under the Analyte Concentration-time Curve From Time Zero to the Time of the Last Measurable Concentration (AUC [0-last])
timeFrame: Up to Day 29
measure: Area Under the Analyte Concentration-time Curve From Time Zero to Infinity (AUC [0-infinity])
timeFrame: Up to Day 29
measure: Total Apparent Oral Clearance (CL/F)
timeFrame: Up to Day 29
measure: Apparent Volume of Distribution (Vd/F)
timeFrame: Up to Day 29
measure: Apparent Terminal Elimination Rate Constant (Lambda[z])
timeFrame: Up to Day 29
measure: Apparent Terminal Elimination Half-life (t1/2)
timeFrame: Up to Day 29
measure: Percentage of JNJ-56136379 Excreted in Urine (Ae,%Dose)
timeFrame: Up to Day 7
measure: Renal Clearance (CLr)
timeFrame: Up to 144 hours postdose
Secondary outcomes:
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: Up to 8 weeks
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Orlando Clinical Research Center
state: Florida
city: San Antonio
country: United States
facility: The Texas Liver Institute
state: Texas
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: