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

Primary Purpose

Renal Insufficiency

Status

Terminated

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

JNJ-56136379

About this trial

This is an interventional other trial for Renal Insufficiency focused on measuring Renal Impairment

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Orlando Clinical Research Center
The Texas Liver Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Active Comparator

Experimental

Arm Label

Part A: Group 1

Part A: Group 2

Part B: Group 3 (Optional)

Part B: Group 4 (Optional)

Part B: Group 5 (Optional)

Arm Description

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.

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 with mild renal impairment (eGFR: 60 to 89 mL/minute) will receive a single oral dose of JNJ-56136379.

Participants with moderate renal impairment (eGFR: 30 to 59 mL/minute) will receive a single oral dose of JNJ-56136379.

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.

Outcomes

Primary Outcome Measures

Maximum Observed Plasma Analyte Concentration (Cmax)

Cmax is defined as the maximum observed plasma analyte concentration.

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.

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.

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.

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.

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.

Total Apparent Oral Clearance (CL/F)

CL/F is defined as total apparent oral clearance, calculated as dose/AUC (0-infinity).

Apparent Volume of Distribution (Vd/F)

Vd/F is defined as apparent volume of distribution, calculated as dose/[lambda (z)*AUC (0-infinity)].

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.

Apparent Terminal Elimination Half-life (t1/2)

t1/2 is defined as apparent terminal elimination half-life, calculated as 0.693/lambda(z).

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).

Renal Clearance (CLr)

CLr is defined as renal clearance, calculated as Ae(0-144h)/AUC(144h).

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT04474210

First Posted

July 14, 2020

Last Updated

July 19, 2021

Sponsor

Janssen Research & Development, LLC

1. Study Identification

Unique Protocol Identification Number

NCT04474210

Brief Title

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

2. Study Status

Record Verification Date

July 2021

Overall Recruitment Status

Terminated

Why Stopped

Strategic Decision

Study Start Date

August 19, 2020 (Actual)

Primary Completion Date

November 30, 2020 (Actual)

Study Completion Date

November 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Janssen Research & Development, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Renal Insufficiency

Keywords

Renal Impairment

7. Study Design

Primary Purpose

Other

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

1 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Part A: Group 1

Arm Type

Experimental

Arm Description

Arm Title

Part A: Group 2

Arm Type

Active Comparator

Arm Description

Healthy participants with normal renal function (eGFR greater than or equal to [>=] 90 mL/minute), will receive a single oral dose of JNJ-56136379.

Arm Title

Part B: Group 3 (Optional)

Arm Type

Experimental

Arm Description

Participants with mild renal impairment (eGFR: 60 to 89 mL/minute) will receive a single oral dose of JNJ-56136379.

Arm Title

Part B: Group 4 (Optional)

Arm Type

Experimental

Arm Description

Participants with moderate renal impairment (eGFR: 30 to 59 mL/minute) will receive a single oral dose of JNJ-56136379.

Arm Title

Part B: Group 5 (Optional)

Arm Type

Experimental

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

JNJ-56136379

Intervention Description

Participants will receive JNJ-56136379 tablets orally.

Primary Outcome Measure Information:

Title

Maximum Observed Plasma Analyte Concentration (Cmax)

Description

Cmax is defined as the maximum observed plasma analyte concentration.

Time Frame

Up to Day 29

Title

Time to Reach the Maximum Observed Plasma Analyte Concentration (Tmax)

Description

Tmax is defined as the actual sampling time to reach the maximum observed plasma analyte concentration.

Time Frame

Up to Day 29

Title

Area Under the Analyte Concentration-time Curve From Time Zero to 24 Hours Postdose (AUC [0-24])

Description

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.

Time Frame

Up to 24 hours postdose

Title

Area Under the Analyte Concentration-time Curve From Time Zero to 144 Hours Postdose (AUC [0-144])

Description

AUC (0-144) is defined as AUC from time 0 to 144 hours postdose, calculated by linear-linear trapezoidal summation.

Time Frame

Up to 144 hours postdose

Title

Area Under the Analyte Concentration-time Curve From Time Zero to the Time of the Last Measurable Concentration (AUC [0-last])

Description

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.

Time Frame

Up to Day 29

Title

Area Under the Analyte Concentration-time Curve From Time Zero to Infinity (AUC [0-infinity])

Description

Time Frame

Up to Day 29

Title

Total Apparent Oral Clearance (CL/F)

Description

CL/F is defined as total apparent oral clearance, calculated as dose/AUC (0-infinity).

Time Frame

Up to Day 29

Title

Apparent Volume of Distribution (Vd/F)

Description

Vd/F is defined as apparent volume of distribution, calculated as dose/[lambda (z)*AUC (0-infinity)].

Time Frame

Up to Day 29

Title

Apparent Terminal Elimination Rate Constant (Lambda[z])

Description

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.

Time Frame

Up to Day 29

Title

Apparent Terminal Elimination Half-life (t1/2)

Description

t1/2 is defined as apparent terminal elimination half-life, calculated as 0.693/lambda(z).

Time Frame

Up to Day 29

Title

Percentage of JNJ-56136379 Excreted in Urine (Ae,%Dose)

Description

Ae,%Dose is defined as cumulative urinary recovery represented as a percentage of dose, calculated as 100*(Aetotal/Dose).

Time Frame

Up to Day 7

Title

Renal Clearance (CLr)

Description

CLr is defined as renal clearance, calculated as Ae(0-144h)/AUC(144h).

Time Frame

Up to 144 hours postdose

Secondary Outcome Measure Information:

Title

Number of Participants with Adverse Events as a Measure of Safety and Tolerability

Description

Time Frame

Up to 8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Janssen Research & Development, LLC Clinical Trial

Organizational Affiliation

Janssen Research & Development, LLC

Official's Role

Study Director

Facility Information:

Facility Name

Orlando Clinical Research Center

City

Orlando

State/Province

Florida

ZIP/Postal Code

32809

Country

United States

Facility Name

The Texas Liver Institute

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78215

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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

IPD Sharing URL

https://www.janssen.com/clinical-trials/transparency

Learn more about this trial

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

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