Clinical trial NCT03546205: A Study to Evaluate JNJ-64565111 Pharmacokinetics and Safety in Adult Participants With Varying Degrees of Renal Function
Official title: A Single-dose, Open-label, Parallel-group Study to Evaluate JNJ-64565111 Pharmacokinetics and Safety in Adult Subjects With Varying Degrees of Renal Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Kidney Failure, Chronic
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2018-06-06
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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)

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

Primary outcomes:
measure: Maximum Observed Serum Analyte Concentration (Cmax) of JNJ-64565111
timeFrame: Predose, 4, 8, 12, 24, 36, 48, 72, 96, 144, 216, 384, 672, and 984 hours postdose
measure: 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
timeFrame: Predose, 4, 8, 12, 24, 36, 48, 72, 96, 144, 216, 384, 672, and 984 hours postdose
measure: Area Under the Serum Analyte Concentration-Time Curve from Time Zero to Infinite Time (AUC[0-infinity]) of JNJ-64565111
timeFrame: Predose, 4, 8, 12, 24, 36, 48, 72, 96, 144, 216, 384, 672, and 984 hours postdose
Secondary outcomes:
measure: Number of Participants with Antibodies to JNJ-64565111
timeFrame: Predose, Days 7, 29 and 42
measure: Number of Participants with Adverse Events
timeFrame: Approximately 9 weeks
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Orlando Clinical Research Center
state: Florida
city: Knoxville
country: United States
facility: AMR New Orleans, Formerly New Orleans Center for Clinical Research - New Orleans, an AMR company
state: Tennessee
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: