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

A Single-dose, Open-label, Parallel-group Study to Evaluate JNJ-64565111 Pharmacokinetics and Safety in Adult Subjects With Varying Degrees of Renal Function

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.

Study Overview

• Status: Completed
• Conditions: Kidney Failure, Chronic
• Intervention / Treatment: Drug: JNJ-64565111

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Orlando, Florida, United States, 32809
      • Orlando Clinical Research Center
  • Tennessee
    • Knoxville, Tennessee, United States, 37923
      • AMR New Orleans, Formerly New Orleans Center for Clinical Research - New Orleans, an AMR company

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: JNJ-64565111; All participants will receive a single SC dose of JNJ-64565111 solution on Day 1.
Experimental: 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.	Drug: JNJ-64565111; All participants will receive a single SC dose of JNJ-64565111 solution on Day 1.
Experimental: 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.	Drug: JNJ-64565111; All participants will receive a single SC dose of JNJ-64565111 solution on Day 1.
Experimental: 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.	Drug: JNJ-64565111; All participants will receive a single SC dose of JNJ-64565111 solution on Day 1.
Experimental: 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.	Drug: JNJ-64565111; All participants will receive a single SC dose of JNJ-64565111 solution on Day 1.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Antibodies to JNJ-64565111	Number of participants with antibodies to JNJ-64565111 will be reported.	Predose, Days 7, 29 and 42
Number of Participants with Adverse Events	An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily have a causal relationship with the relevant investigational product.	Approximately 9 weeks

Collaborators and Investigators

• Sponsor: Janssen Research & Development, LLC

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2018
• Primary Completion (Actual): December 17, 2018
• Study Completion (Actual): December 17, 2018

Study Registration Dates

• First Submitted: May 23, 2018
• First Submitted That Met QC Criteria: May 23, 2018
• First Posted (Actual): June 6, 2018

Study Record Updates

• Last Update Posted (Actual): March 3, 2022
• Last Update Submitted That Met QC Criteria: March 2, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency, Chronic; Kidney Failure, Chronic; Renal Insufficiency
• Other Study ID Numbers: CR108474; 64565111OBE1003 (Other Identifier: Janssen Research & Development, LLC)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No