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

Janssen (J&J Innovative Medicine)

Status and phase: Terminated; Phase 1

Conditions: Renal Insufficiency

Treatments: Drug: JNJ-56136379

Study type: Interventional

Funder types: Industry

Identifiers

NCT04474210

56136379HPB1010 (Other Identifier)

CR108802

Details and patient eligibility

About

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.

Enrollment: 1 patient

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1 participants in 5 patient groups

Part A: Group 1

Experimental group

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.

Treatment:

Drug: JNJ-56136379

Part A: Group 2

Active Comparator group

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.

Treatment:

Drug: JNJ-56136379

Part B: Group 3 (Optional)

Experimental group

Description:

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

Treatment:

Drug: JNJ-56136379

Part B: Group 4 (Optional)

Experimental group

Description:

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

Treatment:

Drug: JNJ-56136379

Part B: Group 5 (Optional)

Experimental group

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.

Treatment:

Drug: JNJ-56136379