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



Status:Recruiting
Conditions:Renal Impairment / Chronic Kidney Disease, Renal Impairment / Chronic Kidney Disease
Therapuetic Areas:Nephrology / Urology
Healthy:No
Age Range:18 - 79
Updated:7/5/2018
Start Date:June 6, 2018
End Date:February 26, 2019
Contact:Study Contact
Email:JNJ.CT@sylogent.com
Phone:844-434-4210

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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.


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
We found this trial at
2
sites
5055 South Orange Ave Orlando FL 32909
Orlando, Florida 32806
407-240-7878
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Knoxville, Tennessee 37920
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