A Study to Evaluate the Effect of Renal Impairment on the Pharmacokinetics of JNJ-64041575 in Adult Participants With Various Degrees of Renal Function

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 1

Conditions: Renal Insufficiency

Treatments: Drug: JNJ-64041575

Study type: Interventional

Funder types: Industry

Identifiers

NCT03189498

64041575RSV1006 (Other Identifier)

2017-000875-10 (EudraCT Number)

CR108333

Details and patient eligibility

About

The primary purpose of this study is to evaluate the pharmacokinetic (PK) and systemic exposure of JNJ-63549109 and JNJ-64167896 after a single oral dose of JNJ-64041575 in adult participants with various degrees of renal function (mildly, moderately, or severely impaired, or end-stage renal disease [ESRD] with or without hemodialysis) compared to adult participants with normal renal function.

Enrollment: 38 patients

Sex: All

Ages: 18 to 79 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participant must have a body mass index (BMI: body weight in kilogram (kg) divided by the square of height in meters) of 18.0 to 36.0 kilogram per meter square (kg/m^2), extremes included, and a body weight not less than 50.0 kg, inclusive, at screening
• Contraceptive use by female participants, male participants and their female partners should be consistent with local regulations regarding the use of contraceptive methods for participants participating in clinical studies if these are stricter than what is proposed in these inclusion criteria in the protocol

Participants with normal renal function (Group 1):

-Participant must have an estimated glomerular filtration rate (eGFR) >= 90 milliliter per minute (mL/min)

Participants with renal impairment (Groups 2 to 4):

• The following classifications of renal function are used: Mild renal impairment (eGFR greater than or equal to [>=] 60 to less than [<] 90 mL/min), Moderate renal impairment (eGFR >= 30 to <60 mL/min), Severe renal impairment (eGFR >=15 to <30 mL/min)

Participants with end-stage renal disease (ESRD) with or without hemodialysis (Group 5):

• Participant must have an eGFR <15 mL/min if not on hemodialysis
• Participant on hemodialysis treatment must have been on the same hemodialysis regimen for at least 3 months before screening

Exclusion criteria

All participants (Groups 1 to 5):

• Participant has any surgical or medical condition that potentially may alter the absorption, metabolism, or excretion of the study drug (example, Crohn's disease), with the exception of renal impairment
• Participant has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (example, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments
• Participant with a history of clinically significant drug allergy such as, but not limited to, sulfonamides and penicillins, or drug allergy diagnosed in previous studies with experimental drugs
• Participant has known allergies, hypersensitivity, or intolerance to JNJ-64041575 or its excipients
• Participants with evidence of an active infection
• Participant is a woman who is pregnant or breastfeeding

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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38 participants in 5 patient groups

Group 1: Participants With Normal Renal Function

Experimental group

Description:

Adult participants with normal renal function (estimated glomerular filtration rate \[eGFR\] greater than or equal to \[\>=\] 90 milliliter per minute \[mL/min\]) will receive a single oral dose of 1,000 milligram (mg) JNJ-64041575 (4\*250-mg tablets) on Day 1 of treatment period.

Treatment:

Drug: JNJ-64041575

Group 2: Participants With Mild Renal Impairment

Experimental group

Description:

Adult participants with mild impaired renal function (eGFR \>=60 to less than \[\<\] 90 mL/min) will receive a single oral dose of 1,000 mg JNJ-64041575 (4\*250-mg tablets) on Day 1 of treatment period.

Treatment:

Drug: JNJ-64041575

Group 3: Participants With Moderate Renal Impairment

Experimental group

Description:

Adult participants with moderate impaired renal function (eGFR \>=30 to \<60 mL/min) will receive a single oral dose of 1,000 mg JNJ-64041575 (4\*250-mg tablets) on Day 1 of treatment period.

Treatment:

Drug: JNJ-64041575

Group 4: Participants With Severe Renal Impairment

Experimental group

Description:

Adult participants with severe impaired renal function (eGFR \>= 15 to \<30 mL/min) will receive a single oral dose of 1,000 mg JNJ-64041575 (4\*250-mg tablets) on Day 1 of treatment period.

Treatment:

Drug: JNJ-64041575

Group 5: Participants With ESRD With or Without Hemodialysis

Experimental group

Description:

Adult participants with end-stage renal disease (ESRD) (eGFR \<15 mL/min if not on hemodialysis or requiring hemodialysis treatment for at least 3 months before screening if on hemodialysis) will receive a single oral dose of 1,000 mg JNJ-64041575 (4\*250-mg tablets) on Day 1 of treatment period. Participants with ESRD on hemodialysis will be dosed on an interdialysis day within 24 hours of their last hemodialysis treatment.

Treatment:

Drug: JNJ-64041575