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

NCT03546205 | Completed Phase 1 FDA Drug

• 2 other identifiers: CR10847464565111OBE1003
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (3)

• Maximum Observed Serum Analyte Concentration (Cmax) of JNJ-64565111

  Cmax is the maximum observed serum analyte concentration of JNJ-64565111.

  Predose, 4, 8, 12, 24, 36, 48, 72, 96, 144, 216, 384, 672, and 984 hours postdose

• Area Under the Serum Analyte Concentration-Time Curve from Time Zero to Last Measurable (not Below Quantification Limit) Concentration (AUC[0-last]) of JNJ-64565111

  AUC \[0-Last\] is the area under the serum analyte concentration versus time curve from time zero to the time of the last measurable (not below quantification limit) concentration of JNJ-64565111, calculated by linear-linear trapezoidal summation.

  Predose, 4, 8, 12, 24, 36, 48, 72, 96, 144, 216, 384, 672, and 984 hours postdose

• Area Under the Serum Analyte Concentration-Time Curve from Time Zero to Infinite Time (AUC[0-infinity]) of JNJ-64565111

  AUC (0-infinity) is the area under the serum analyte concentration-time curve from time zero to infinite time, calculated as AUC(last) + C(last)/lamda(z) where C(last) is the last observed measurable (not below quantification limit) concentration of JNJ-64565111.

  Predose, 4, 8, 12, 24, 36, 48, 72, 96, 144, 216, 384, 672, and 984 hours postdose

Secondary Outcomes (2)

• Number of Participants with Antibodies to JNJ-64565111

  Predose, Days 7, 29 and 42

• Number of Participants with Adverse Events

  Approximately 9 weeks

Study Arms (5)

Group 1: JNJ-64565111

EXPERIMENTAL

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.

Drug: JNJ-64565111

Group 2: JNJ-64565111

EXPERIMENTAL

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.

Drug: JNJ-64565111

Group 3: JNJ-64565111

EXPERIMENTAL

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.

Drug: JNJ-64565111

Group 4: JNJ-64565111

EXPERIMENTAL

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.

Drug: JNJ-64565111

Group 5: JNJ-64565111

EXPERIMENTAL

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.

Drug: JNJ-64565111

Interventions

JNJ-64565111 DRUG

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

Group 1: JNJ-64565111; Group 2: JNJ-64565111; Group 3: JNJ-64565111; Group 4: JNJ-64565111; Group 5: JNJ-64565111

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (2)

Orlando Clinical Research Center

Orlando, Florida, 32809, United States

Location

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

Knoxville, Tennessee, 37923, United States

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2018
• First Posted: June 6, 2018
• Study Start: June 6, 2018
• Primary Completion: December 17, 2018
• Study Completion: December 17, 2018
• Last Updated: April 27, 2025

Record last verified: 2025-04

Locations

US (2)