A Study to Evaluate JNJ-64565111 Pharmacokinetics and Safety in Adult Participants With Varying Degrees of Renal Function

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 1

Conditions: Kidney Failure, Chronic

Treatments: Drug: JNJ-64565111

Study type: Interventional

Funder types: Industry

Identifiers

NCT03546205

CR108474

64565111OBE1003 (Other Identifier)

Details and patient eligibility

About

The purpose of study is to evaluate the pharmacokinetics of a single, subcutaneous dose of JNJ-64565111 in adult participants with varying degrees of renal function including participants with end stage renal disease, requiring hemodialysis, compared with participants with normal renal function.

Enrollment: 40 patients

Sex: All

Ages: 18 to 79 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• If a woman, must be postmenopausal (no spontaneous menses for at least 2 years), surgically sterile, or if sexually active, be practicing an effective method of birth control before entry and throughout the study
• A woman must have a negative highly sensitive serum (beta human chorionic gonadotropin [hCG]) at screening. On Day -1, female non-end-stage renal disease (ESRD) participants should have a negative urine pregnancy test and female ESRD participants requiring hemodialysis (HD) should have a negative serum pregnancy test
• A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction (from screening through Day 42 postdose)
• Body mass index (weight [kilogram {kg}]/height^2 [ meter {m}]^2) between 18 and 40 kg/m^2 (inclusive), and body weight not less than 50 kg
• Have normal renal function defined as: predicted estimated glomerular filtration rate greater than or equal to (>=) 90 milliliter (mL)/minute based on the Chronic Kidney Disease-Epidemiology formula (for participants with normal renal function)

Exclusion criteria

• History of, or a reason to believe a participant has a history of, drug or alcohol abuse according to Diagnostic and Statistical Manual of Mental Disorders (5th edition) (DSM V) criteria within 5 years before screening or positive test result(s) for alcohol and/or drugs of abuse (such as barbiturates, opiates, opioids, cocaine, cannabinoids, amphetamines, and benzodiazepines) at screening and Day -1 of the treatment period (unless medically prescribed)
• Any surgical or medical condition that potentially may alter the absorption, metabolism, or excretion of the study drug, with the exception of renal impairment as described in the inclusion criteria, and except for participants who had a cholecystectomy or a hernia repair
• History of clinically significant allergies, especially known hypersensitivity or intolerances
• Known allergy to JNJ-64565111 or its excipients
• Donated blood or blood products or had substantial loss of blood (more than 500 mL) within 3 months before the first administration of study drug or intention to donate blood or blood products during the study or at least 2 months after the completion of the study

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 5 patient groups

Group 1: JNJ-64565111

Experimental group

Description:

Participants with normal renal function and no evidence of kidney damage (estimated glomerular filtration rate \[eGFR\] greater than or equal to \[\>=\] 90 milliliter/minute \[mL/min\]) will be enrolled. Participants will receive a single subcutaneous (SC) dose of JNJ-64565111 on Day 1.

Treatment:

Drug: JNJ-64565111

Group 2: JNJ-64565111

Experimental group

Description:

Participants with mild renal impairment (eGFR 60 to less than \[\<\] 90 mL/min) will be enrolled. Participants will receive a single SC dose of JNJ-64565111 on Day 1.

Treatment:

Drug: JNJ-64565111

Group 3: JNJ-64565111

Experimental group

Description:

Participants with moderate renal impairment (eGFR 30 to \<60 mL/min) will be enrolled. Participants will receive a single SC dose of JNJ-64565111 on Day 1.

Treatment:

Drug: JNJ-64565111

Group 4: JNJ-64565111

Experimental group

Description:

Participants with severe renal impairment (eGFR \<30 mL/min) will be enrolled. Participants will receive a single SC dose of JNJ-64565111 on Day 1.

Treatment:

Drug: JNJ-64565111

Group 5: JNJ-64565111

Experimental group

Description:

Participants with end-stage renal disease (requiring hemodialysis 3 times per week for at least 3 months before screening; eGFR will not be calculated) will be enrolled. Participants will receive a single SC dose of JNJ-64565111 on Day 1.

Treatment:

Drug: JNJ-64565111