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

A Phase 1, Open-label, Single-dose, Parallel-group Study to Evaluate the Effect of Renal Impairment on the Pharmacokinetics of JNJ-64041575 in Adult Subjects With Various Degrees of Renal Function

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.

Study Overview

• Status: Completed
• Conditions: Renal Insufficiency
• Intervention / Treatment: Drug: JNJ-64041575

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Kiel, Germany
    • CRS Clinical Research Services Kiel
  • Munchen, Germany, 81241
    • Apex Gmbh

Participation Criteria

Eligibility Criteria

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

Description

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

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: Participants With Normal Renal Function; 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.	Drug: JNJ-64041575; All participants will receive a single oral dose of 1,000 mg JNJ-64041575 (4*250 mg tablets) on Day 1.; Other Names: ALS-008176, lumicitabine
Experimental: Group 2: Participants With Mild Renal Impairment; 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.	Drug: JNJ-64041575; All participants will receive a single oral dose of 1,000 mg JNJ-64041575 (4*250 mg tablets) on Day 1.; Other Names: ALS-008176, lumicitabine
Experimental: Group 3: Participants With Moderate Renal Impairment; 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.	Drug: JNJ-64041575; All participants will receive a single oral dose of 1,000 mg JNJ-64041575 (4*250 mg tablets) on Day 1.; Other Names: ALS-008176, lumicitabine
Experimental: Group 4: Participants With Severe Renal Impairment; 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.	Drug: JNJ-64041575; All participants will receive a single oral dose of 1,000 mg JNJ-64041575 (4*250 mg tablets) on Day 1.; Other Names: ALS-008176, lumicitabine
Experimental: Group 5: Participants With ESRD With or Without Hemodialysis; 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.	Drug: JNJ-64041575; All participants will receive a single oral dose of 1,000 mg JNJ-64041575 (4*250 mg tablets) on Day 1.; Other Names: ALS-008176, lumicitabine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum Observed Plasma Concentration (Cmax)	The Cmax is the maximum observed plasma concentration.	Predose, Day 1: 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, and 336 (Day 15) hours postdose
Area Under the Plasma Concentration-time Curve From Time Zero to Last Measurable Concentration (AUC [0-last])	The AUC (0-last) is the area under the plasma concentration-time curve from time zero to the time of the last measurable concentration.	Predose, Day 1: 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, and 336 (Day 15) hours postdose
Area Under the Plasma Concentration-time Curve From Time Zero to Infinite Time (AUC [0-infinity])	The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC(last) and C(last)/lambda(z); wherein AUC(last) is area under the plasma concentration-time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant.	Predose, Day 1: 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, and 336 (Day 15) hours postdose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Adverse Events as a Measure of Safety and Tolerability	An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.	Up to 20 to 28 days after study drug intake (approximately 5 months)

Collaborators and Investigators

• Sponsor: Janssen Pharmaceutica N.V., Belgium
• Investigators: Study Director: Janssen Pharmaceutica N.V., Belgium Clinical trial, Janssen Pharmaceutica N.V., Belgium

Study record dates

Study Major Dates

• Study Start (Actual): July 11, 2017
• Primary Completion (Actual): December 6, 2017
• Study Completion (Actual): December 6, 2017

Study Registration Dates

• First Submitted: June 15, 2017
• First Submitted That Met QC Criteria: June 15, 2017
• First Posted (Actual): June 16, 2017

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 31, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Renal Insufficiency
• Other Study ID Numbers: CR108333; 2017-000875-10 (EudraCT Number); 64041575RSV1006 (Other Identifier: Janssen Pharmaceutica N.V., Belgium)

Drug and device information, study documents

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