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

July 19, 2021 updated by: Janssen Research & Development, LLC

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Florida
      • Orlando, Florida, United States, 32809
        • Orlando Clinical Research Center
    • Texas
      • San Antonio, Texas, United States, 78215
        • The Texas Liver Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part A: Group 1
Participants with severe renal impairment and/or kidney failure (estimated glomerular filtration rate [eGFR] less than [<] 30 milliliter[mL]/minute but not yet on hemodialysis) will receive a single oral dose of JNJ-56136379.
Participants will receive JNJ-56136379 tablets orally.
Active Comparator: Part A: Group 2
Healthy participants with normal renal function (eGFR greater than or equal to [>=] 90 mL/minute), will receive a single oral dose of JNJ-56136379.
Participants will receive JNJ-56136379 tablets orally.
Experimental: Part B: Group 3 (Optional)
Participants with mild renal impairment (eGFR: 60 to 89 mL/minute) will receive a single oral dose of JNJ-56136379.
Participants will receive JNJ-56136379 tablets orally.
Experimental: Part B: Group 4 (Optional)
Participants with moderate renal impairment (eGFR: 30 to 59 mL/minute) will receive a single oral dose of JNJ-56136379.
Participants will receive JNJ-56136379 tablets orally.
Experimental: Part B: Group 5 (Optional)
Participants with kidney failure (eGFR: <15 mL/minute and on hemodialysis; pharmacokinetic [PK] to be evaluated during non-dialysis days) will receive a single oral dose of JNJ-56136379.
Participants will receive JNJ-56136379 tablets orally.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum Observed Plasma Analyte Concentration (Cmax)
Time Frame: Up to Day 29
Cmax is defined as the maximum observed plasma analyte concentration.
Up to Day 29
Time to Reach the Maximum Observed Plasma Analyte Concentration (Tmax)
Time Frame: Up to Day 29
Tmax is defined as the actual sampling time to reach the maximum observed plasma analyte concentration.
Up to Day 29
Area Under the Analyte Concentration-time Curve From Time Zero to 24 Hours Postdose (AUC [0-24])
Time Frame: Up to 24 hours postdose
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
Area Under the Analyte Concentration-time Curve From Time Zero to 144 Hours Postdose (AUC [0-144])
Time Frame: Up to 144 hours postdose
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
Area Under the Analyte Concentration-time Curve From Time Zero to the Time of the Last Measurable Concentration (AUC [0-last])
Time Frame: Up to Day 29
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
Area Under the Analyte Concentration-time Curve From Time Zero to Infinity (AUC [0-infinity])
Time Frame: Up to Day 29
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
Total Apparent Oral Clearance (CL/F)
Time Frame: Up to Day 29
CL/F is defined as total apparent oral clearance, calculated as dose/AUC (0-infinity).
Up to Day 29
Apparent Volume of Distribution (Vd/F)
Time Frame: Up to Day 29
Vd/F is defined as apparent volume of distribution, calculated as dose/[lambda (z)*AUC (0-infinity)].
Up to Day 29
Apparent Terminal Elimination Rate Constant (Lambda[z])
Time Frame: Up to Day 29
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
Apparent Terminal Elimination Half-life (t1/2)
Time Frame: Up to Day 29
t1/2 is defined as apparent terminal elimination half-life, calculated as 0.693/lambda(z).
Up to Day 29
Percentage of JNJ-56136379 Excreted in Urine (Ae,%Dose)
Time Frame: Up to Day 7
Ae,%Dose is defined as cumulative urinary recovery represented as a percentage of dose, calculated as 100*(Aetotal/Dose).
Up to Day 7
Renal Clearance (CLr)
Time Frame: Up to 144 hours postdose
CLr is defined as renal clearance, calculated as Ae(0-144h)/AUC(144h).
Up to 144 hours postdose

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time Frame: Up to 8 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 19, 2020

Primary Completion (Actual)

November 30, 2020

Study Completion (Actual)

November 30, 2020

Study Registration Dates

First Submitted

July 14, 2020

First Submitted That Met QC Criteria

July 14, 2020

First Posted (Actual)

July 16, 2020

Study Record Updates

Last Update Posted (Actual)

July 23, 2021

Last Update Submitted That Met QC Criteria

July 19, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CR108802
  • 56136379HPB1010 (Other Identifier: Janssen Research & Development, LLC)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency.

As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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