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

NCT ID: NCT03546205

Last Updated: 2025-04-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-06
• Study Completion Date: 2018-12-17

Brief Summary

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.

Conditions

Kidney Failure, Chronic

Study Design

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

Study Groups

Group 1: JNJ-64565111

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.

Group Type: EXPERIMENTAL

JNJ-64565111

Intervention Type: DRUG

All participants will receive a single SC dose of JNJ-64565111 solution on Day 1.

Group 2: JNJ-64565111

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.

Group Type: EXPERIMENTAL

JNJ-64565111

Intervention Type: DRUG

All participants will receive a single SC dose of JNJ-64565111 solution on Day 1.

Group 3: JNJ-64565111

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.

Group Type: EXPERIMENTAL

JNJ-64565111

Intervention Type: DRUG

All participants will receive a single SC dose of JNJ-64565111 solution on Day 1.

Group 4: JNJ-64565111

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.

Group Type: EXPERIMENTAL

JNJ-64565111

Intervention Type: DRUG

All participants will receive a single SC dose of JNJ-64565111 solution on Day 1.

Group 5: JNJ-64565111

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.

Group Type: EXPERIMENTAL

JNJ-64565111

Intervention Type: DRUG

All participants will receive a single SC dose of JNJ-64565111 solution on Day 1.

Interventions

JNJ-64565111

All participants will receive a single SC dose of JNJ-64565111 solution on Day 1.

Intervention Type: DRUG

Eligibility Criteria

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)

• 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

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 79 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

AMR New Orleans, Formerly New Orleans Center for Clinical Research - New Orleans, an AMR company

Knoxville, Tennessee, United States

Countries

United States

Other Identifiers

64565111OBE1003

Identifier Type: OTHER

Identifier Source: secondary_id

CR108474

Identifier Type: -

Identifier Source: org_study_id