A Study to Evaluate the Effect of Renal Impairment on JNJ-56136379 in Adult Participants

Renal Insufficiency Clinical Trial

Official title:

An Open-Label, Single-Dose Study to Evaluate the Effect of Renal Impairment on the Pharmacokinetics of JNJ-56136379 in Adult Participants

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04474210
• Other study ID #: CR108802
• Secondary ID: 56136379HPB1010
• Status: Terminated
• Phase: Phase 1
• Start date: August 19, 2020
• Est. completion date: November 30, 2020

Study information

• Verified date: July 2021
• 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 pharmacokinetics (PK) of a single oral dose of JNJ-56136379 in adult participants with renal impairment compared with healthy participants with normal renal function.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: November 30, 2020
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Renal Insufficiency

Intervention

Drug:
• JNJ-56136379
Participants will receive JNJ-56136379 tablets orally.

Locations

Country	Name	City	State
United States	Orlando Clinical Research Center	Orlando	Florida
United States	The Texas Liver Institute	San Antonio	Texas

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)	Cmax is defined as the maximum observed plasma analyte concentration.	Up to Day 29
Primary	Time to Reach the Maximum Observed Plasma Analyte Concentration (Tmax)	Tmax is defined as the actual sampling time to reach the maximum observed plasma analyte concentration.	Up to Day 29
Primary	Area Under the Analyte Concentration-time Curve From Time Zero to 24 Hours Postdose (AUC [0-24])	AUC (0-24) is defined as area under the analyte concentration-time curve (AUC) from time 0 to 24 hours postdose, calculated by linear-linear trapezoidal summation.	Up to 24 hours postdose
Primary	Area Under the Analyte Concentration-time Curve From Time Zero to 144 Hours Postdose (AUC [0-144])	AUC (0-144) is defined as AUC from time 0 to 144 hours postdose, calculated by linear-linear trapezoidal summation.	Up to 144 hours postdose
Primary	Area Under the Analyte Concentration-time Curve From Time Zero to the Time of the Last Measurable Concentration (AUC [0-last])	AUC (0-last) is defined as AUC from time 0 to the time of the last measurable (non-below quantification limit [non-BQL]) concentration, calculated by linear-linear trapezoidal summation.	Up to Day 29
Primary	Area Under the Analyte Concentration-time Curve From Time Zero to Infinity (AUC [0-infinity])	AUC (0-infinity) is defined as AUC from time 0 to infinity, calculated as the sum of AUC (0-last) and C(last)/lambda(z); where C(last) is the last observed measurable (non-BQL) concentration; and lambda(z) is apparent terminal elimination rate constant.	Up to Day 29
Primary	Total Apparent Oral Clearance (CL/F)	CL/F is defined as total apparent oral clearance, calculated as dose/AUC (0-infinity).	Up to Day 29
Primary	Apparent Volume of Distribution (Vd/F)	Vd/F is defined as apparent volume of distribution, calculated as dose/[lambda (z)*AUC (0-infinity)].	Up to Day 29
Primary	Apparent Terminal Elimination Rate Constant (Lambda[z])	Lambda(z) is defined as apparent terminal elimination rate constant, estimated by linear regression using the terminal log-linear phase of the log-transformed concentration vs time curve.	Up to Day 29
Primary	Apparent Terminal Elimination Half-life (t1/2)	t1/2 is defined as apparent terminal elimination half-life, calculated as 0.693/lambda(z).	Up to Day 29
Primary	Percentage of JNJ-56136379 Excreted in Urine (Ae,%Dose)	Ae,%Dose is defined as cumulative urinary recovery represented as a percentage of dose, calculated as 100*(Aetotal/Dose).	Up to Day 7
Primary	Renal Clearance (CLr)	CLr is defined as renal clearance, calculated as Ae(0-144h)/AUC(144h).	Up to 144 hours postdose
Secondary	Number of Participants with Adverse Events as a Measure of Safety and Tolerability	An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.	Up to 8 weeks

External Links

•   To learn how to participate in this trial please click here.