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Completed

NCT Number: NCT03189498

A Study to Evaluate the Effect of Renal Impairment on the Pharmacokinetics of JNJ-64041575 in Adult Participants 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.

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Key information

Conditions

Renal Insufficiency Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Urogenital Diseases Urologic Diseases

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

CRS Clinical Research Services Kiel, Kiel, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

JNJ-64041575

Drug

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

Primary outcomes

  1. Maximum Observed Plasma Concentration (Cmax)

    Time frame: 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

    The Cmax is the maximum observed plasma concentration.

  2. Area Under the Plasma Concentration-time Curve From Time Zero to Last Measurable Concentration (AUC [0-last])

    Time frame: 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

    The AUC (0-last) is the area under the plasma concentration-time curve from time zero to the time of the last measurable concentration.

  3. Area Under the Plasma Concentration-time Curve From Time Zero to Infinite Time (AUC [0-infinity])

    Time frame: 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

    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.

Secondary outcomes

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

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

    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.

Sponsors and collaborators

Lead sponsor

Janssen Pharmaceutica N.V., Belgium

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jun 16, 2017
Registry last updated
Feb 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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