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

NCT03189498 | Completed Phase 1

• 3 other identifiers: CR1083332017-000875-1064041575RSV1006
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Renal Insufficiency

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Number of Participants With Adverse Events as a Measure of Safety and Tolerability

  Up to 20 to 28 days after study drug intake (approximately 5 months)

Study Arms (5)

Group 1: Participants With Normal Renal Function

EXPERIMENTAL

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

Group 2: Participants With Mild Renal Impairment

EXPERIMENTAL

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

Group 3: Participants With Moderate Renal Impairment

EXPERIMENTAL

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

Group 4: Participants With Severe Renal Impairment

EXPERIMENTAL

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

Group 5: Participants With ESRD With or Without Hemodialysis

EXPERIMENTAL

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

Interventions

JNJ-64041575 DRUG

All participants will receive a single oral dose of 1,000 mg JNJ-64041575 (4\*250 mg tablets) on Day 1.

Also known as: ALS-008176, lumicitabine

Group 1: Participants With Normal Renal Function; Group 2: Participants With Mild Renal Impairment; Group 3: Participants With Moderate Renal Impairment; Group 4: Participants With Severe Renal Impairment; Group 5: Participants With ESRD With or Without Hemodialysis

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Pharmaceutica N.V., Belgium: lead

Study Sites (2)

CRS Clinical Research Services Kiel

Kiel, Germany

Location

APEX GmbH

München, 81241, Germany

Location

MeSH Terms

Conditions

Renal Insufficiency

Interventions

4'-chloromethyl-2'-deoxy-3',5'-di-O-isobutyryl-2'-fluorocytidine

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Janssen Pharmaceutica N.V., Belgium Clinical Trial

  Janssen Pharmaceutica N.V., Belgium

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2017
• First Posted: June 16, 2017
• Study Start: July 11, 2017
• Primary Completion: December 6, 2017
• Study Completion: December 6, 2017
• Last Updated: February 3, 2025

Record last verified: 2025-01

Locations

DE (2)