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

NCT ID: NCT04474210

Last Updated: 2021-07-23

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-19
• Study Completion Date: 2020-11-30

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.

Conditions

Renal Insufficiency

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

JNJ-56136379

Intervention Type: DRUG

Participants will receive JNJ-56136379 tablets orally.

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.

Group Type: ACTIVE_COMPARATOR

JNJ-56136379

Intervention Type: DRUG

Participants will receive JNJ-56136379 tablets orally.

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.

Group Type: EXPERIMENTAL

JNJ-56136379

Intervention Type: DRUG

Participants will receive JNJ-56136379 tablets orally.

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.

Group Type: EXPERIMENTAL

JNJ-56136379

Intervention Type: DRUG

Participants will receive JNJ-56136379 tablets orally.

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.

Group Type: EXPERIMENTAL

JNJ-56136379

Intervention Type: DRUG

Participants will receive JNJ-56136379 tablets orally.

Interventions

JNJ-56136379

Participants will receive JNJ-56136379 tablets orally.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

Orlando Clinical Research Center

Orlando, Florida, United States

The Texas Liver Institute

San Antonio, Texas, United States

Countries

United States

Other Identifiers

56136379HPB1010

Identifier Type: OTHER

Identifier Source: secondary_id

CR108802

Identifier Type: -

Identifier Source: org_study_id