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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 safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03189498
Recruitment Status : Completed
First Posted : June 16, 2017
Last Update Posted : April 17, 2018
Sponsor:
Information provided by (Responsible Party):
Janssen Pharmaceutica N.V., Belgium

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.

Condition or disease Intervention/treatment Phase
Renal Insufficiency Drug: JNJ-64041575 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official 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
Actual Study Start Date : July 11, 2017
Actual Primary Completion Date : December 6, 2017
Actual Study Completion Date : December 6, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Tests

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 Name: 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 Name: 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 Name: 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 Name: 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 Name: ALS-008176, lumicitabine




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03189498


Locations
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Germany
CRS Clinical Research Services Kiel
Kiel, Germany
APEX GmbH
München, Germany, 81241
Sponsors and Collaborators
Janssen Pharmaceutica N.V., Belgium
Investigators
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Study Director: Janssen Pharmaceutica N.V., Belgium Clinical Trial Janssen Pharmaceutica N.V., Belgium
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Responsible Party: Janssen Pharmaceutica N.V., Belgium
ClinicalTrials.gov Identifier: NCT03189498    
Other Study ID Numbers: CR108333
2017-000875-10 ( EudraCT Number )
64041575RSV1006 ( Other Identifier: Janssen Pharmaceutica N.V., Belgium )
First Posted: June 16, 2017    Key Record Dates
Last Update Posted: April 17, 2018
Last Verified: April 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Renal Insufficiency
Kidney Diseases
Urologic Diseases