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A Study to Evaluate the Effect of Renal Impairment on JNJ-64417184 and Its Two Minor Metabolites JNJ-68294291 and JNJ-65201526 in Adult Participants

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ClinicalTrials.gov Identifier: NCT04426357
Recruitment Status : Terminated (company decision)
First Posted : June 11, 2020
Last Update Posted : January 15, 2021
Sponsor:
Information provided by (Responsible Party):
Janssen Pharmaceutica N.V., Belgium

Brief Summary:
The main purpose of this study is to evaluate the pharmacokinetics of JNJ-64417184, JNJ-68294291, and JNJ-65201526 after a single oral dose of JNJ-64417184 in adult participants with various degrees of impaired renal function (moderate [optional], severe renal impairment, and end stage renal disease (ESRD) not requiring hemodialysis) compared to participants with normal renal function.

Condition or disease Intervention/treatment Phase
Renal Impairment Drug: JNJ-64417184 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Single-dose, Open-label, Parallel-group Study to Evaluate the Effect of Renal Impairment on the Pharmacokinetics of JNJ-64417184 and Its Two Minor Metabolites JNJ-68294291 and JNJ-65201526 in Adult Participants
Actual Study Start Date : July 3, 2020
Actual Primary Completion Date : November 12, 2020
Actual Study Completion Date : November 12, 2020

Arm Intervention/treatment
Experimental: Group 1 (Participants with Renal impairment): JNJ-64417184
Participants with varying degrees of impaired renal impairment function (moderate renal impairment [optional], severe renal impairment, and end stage renal disease [ESRD] not requiring hemodialysis) will be enrolled and will receive a single oral dose of JNJ-64417184 as film coated tablet on Day 1.
Drug: JNJ-64417184
Participants will receive single oral (as film coated tablet) dose of JNJ-64417184 on Day 1.

Active Comparator: Group 2 (Healthy Participants): Control Group
Participants with normal renal function will be enrolled in controlled group and will receive a single oral dose of JNJ-64417184 as film coated tablet on Day 1.
Drug: JNJ-64417184
Participants will receive single oral (as film coated tablet) dose of JNJ-64417184 on Day 1.




Primary Outcome Measures :
  1. Maximum Observed Plasma Analyte Concentration (Cmax) of JNJ-64417184and its Metabolites (JNJ-68294291 and JNJ-65201526) [ Time Frame: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 120 and 216 hours post dose ]
    Cmax is defined as maximum observed plasma analyte concentration of JNJ-64417184 and its metabolites (JNJ-68294291 and JNJ-65201526).

  2. Area under the Plasma Analyte Concentration Time Curve from Time 0 to Time of the Last Measurable Concentration [AUC (0-Last)] of JNJ-64417184 and its Metabolites (JNJ-68294291 and JNJ-65201526) [ Time Frame: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 120 and 216 hours post dose ]
    AUC (0-Last) is defined as area under the plasma analyte concentration time curve from time 0 to time of the last measurable (non-below quantification limit [BQL]) concentration of JNJ-64417184 and its metabolites (JNJ-68294291 and JNJ-65201526).

  3. Area Under the Plasma Analyte Concentration Time Curve from Time 0 to Infinite Time [AUC (0-Infinity)] of JNJ-64417184 and its Metabolites (JNJ-68294291 and JNJ-65201526) [ Time Frame: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 120 and 216 hours post dose ]
    AUC (0-infinity) is defined as area under the plasma analyte concentration time curve from time 0 to infinite time, calculated as AUC (last) plus C(last)/(lambda)z, where C (last) is the last observed measurable (non-BQL) plasma analyte concentration; extrapolations of more than 20 percent (%) of the total AUC (that is, percent AUC (infinity), extrapolations greater than [>] 20%) are reported as approximations of JNJ-64417184 and its metabolites (JNJ-68294291 and JNJ-65201526).


Secondary Outcome Measures :
  1. Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability [ Time Frame: Up to Day 11 ]
    An AE 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:   Yes
Criteria

Inclusion Criteria:

  • Participants with normal renal function:

must have normal renal function defined as: estimated glomerular filtration rate (eGFR) greater than or equal to (>=) 90 milliliter per minute per 1.73 meter square (mL/min/1.73 m^2 (calculated by the modification of diet in renal disease [MDRD] formula)

  • Healthy on the basis of physical examination, medical and surgical history, and vital signs performed at screening. If there are abnormalities, the participant may be included only if the investigator judges the abnormalities to be not clinically significant or to be appropriate and reasonable for the population under study. This determination must be recorded in the participant's source documents and initialed by the investigator
  • Participants with moderate or severe renal impairment:

must meet the following additional inclusion criteria to be enrolled in the study: must be otherwise healthy except for the renal impairment and its underlying disease states and mild comorbidities and participant must be medically stable on the basis of physical examination, medical history, vital signs, 12-lead Electrocardiogram (ECG), and clinical laboratory tests performed at screening. If there are abnormalities or results outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant or to be appropriate and reasonable for the population under study. This determination must be recorded in the participant's source documents and initialed by the investigator

  • Participants with end stage renal disease (ESRD): must have a hematocrit at screening of greater than or equal to (>=) 30 percent (%)
  • Must not smoke more than 10 cigarettes or 2 cigars or 2 pipes per day from within 3 months prior to screening until the end of the study

Exclusion Criteria:

  • History of any illness (unrelated to renal impairment or its underlying disease, as appropriate) that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the participant. This may include but is not limited to history of relevant drug or food allergies, history of cardiovascular or central nervous system disease, history or presence of clinically significant pathology, chronic skin disease, or history of mental disease
  • Known allergies, hypersensitivity, or intolerance to JNJ-64417184 or any of its excipients
  • Past history of clinically significant cardiac arrhythmias (example, extrasystole, tachycardia at rest), history of risk factors for Torsade de Pointes syndrome (example, hypokalemia, family history of long QT Syndrome)
  • Any evidence of clinically significant heart block or bundle branch block at screening
  • Current human immunodeficiency virus type 1 (HIV-1) or HIV-2 infection (confirmed by antibodies) at screening
  • History of hepatitis A, B, or C infection, or current hepatitis A infection (confirmed by hepatitis A antibody immunoglobulin M [IgM]), or hepatitis B virus (HBV) infection (confirmed by hepatitis B surface antigen), or hepatitis C virus (HCV) infection (confirmed by HCV antibody) at screening

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): NCT04426357


Locations
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Germany
CRS Clinical Research Services Kiel GmbH
Kiel, Germany, 24105
APEX GmbH
Munchen, 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: NCT04426357    
Other Study ID Numbers: CR108800
2019-004929-25 ( EudraCT Number )
64417184RSV1008 ( Other Identifier: Janssen Pharmaceutica N.V., Belgium )
First Posted: June 11, 2020    Key Record Dates
Last Update Posted: January 15, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency.

As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

URL: https://www.janssen.com/clinical-trials/transparency

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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