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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

Primary Purpose

Renal Insufficiency

Status

Completed

Phase

Phase 1

Locations

Germany

Study Type

Interventional

Intervention

JNJ-64041575

About this trial

This is an interventional other trial for Renal Insufficiency

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

CRS Clinical Research Services Kiel
APEX GmbH

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Arm Label

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

Arm 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.

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Maximum Observed Plasma Concentration (Cmax)

The Cmax is the maximum observed plasma concentration.

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.

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT03189498

First Posted

June 15, 2017

Last Updated

April 12, 2018

Sponsor

Janssen Pharmaceutica N.V., Belgium

1. Study Identification

Unique Protocol Identification Number

NCT03189498

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2018

Overall Recruitment Status

Completed

Study Start Date

July 11, 2017 (Actual)

Primary Completion Date

December 6, 2017 (Actual)

Study Completion Date

December 6, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Janssen Pharmaceutica N.V., Belgium

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Renal Insufficiency

7. Study Design

Primary Purpose

Other

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

38 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group 1: Participants With Normal Renal Function

Arm Type

Experimental

Arm Description

Arm Title

Group 2: Participants With Mild Renal Impairment

Arm Type

Experimental

Arm 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.

Arm Title

Group 3: Participants With Moderate Renal Impairment

Arm Type

Experimental

Arm 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.

Arm Title

Group 4: Participants With Severe Renal Impairment

Arm Type

Experimental

Arm 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.

Arm Title

Group 5: Participants With ESRD With or Without Hemodialysis

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

JNJ-64041575

Other Intervention Name(s)

ALS-008176, lumicitabine

Intervention Description

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

Primary Outcome Measure Information:

Title

Maximum Observed Plasma Concentration (Cmax)

Description

The Cmax is the maximum observed plasma concentration.

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

Title

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

Description

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

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

Title

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

Description

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

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

79 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Janssen Pharmaceutica N.V., Belgium Clinical Trial

Organizational Affiliation

Janssen Pharmaceutica N.V., Belgium

Official's Role

Study Director

Facility Information:

Facility Name

CRS Clinical Research Services Kiel

City

Kiel

Country

Germany

Facility Name

APEX GmbH

City

München

ZIP/Postal Code

81241

Country

Germany

12. IPD Sharing Statement

Learn more about this trial

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

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