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

NCT04426357 | Terminated Phase 1

• 3 other identifiers: CR1088002019-004929-2564417184RSV1008
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 2

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.

Conditions

Renal Impairment

Outcome Measures

Primary Outcomes (3)

• Maximum Observed Plasma Analyte Concentration (Cmax) of JNJ-64417184and its Metabolites (JNJ-68294291 and JNJ-65201526)

  Cmax is defined as maximum observed plasma analyte concentration of JNJ-64417184 and its metabolites (JNJ-68294291 and JNJ-65201526).

  Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 120 and 216 hours post dose

• 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)

  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).

  Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 120 and 216 hours post dose

• 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)

  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).

  Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 120 and 216 hours post dose

Secondary Outcomes (1)

• Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability

  Up to Day 11

Study Arms (2)

Group 1 (Participants with Renal impairment): JNJ-64417184

EXPERIMENTAL

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

Group 2 (Healthy Participants): Control Group

ACTIVE COMPARATOR

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

Interventions

JNJ-64417184 DRUG

Participants will receive single oral (as film coated tablet) dose of JNJ-64417184 on Day 1.

Group 1 (Participants with Renal impairment): JNJ-64417184; Group 2 (Healthy Participants): Control Group

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Pharmaceutica N.V., Belgium: lead

Study Sites (2)

CRS Clinical Research Services Kiel GmbH

Kiel, 24105, Germany

Location

APEX GmbH

München, 81241, Germany

Location

MeSH Terms

Conditions

Renal Insufficiency

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 8, 2020
• First Posted: June 11, 2020
• Study Start: July 3, 2020
• Primary Completion: November 12, 2020
• Study Completion: November 12, 2020
• Last Updated: January 15, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will share

Locations

DE (2)