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

NCT ID: NCT04426357

Last Updated: 2021-01-15

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-03
• Study Completion Date: 2020-11-12

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

JNJ-64417184

Intervention Type: DRUG

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

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.

Group Type: ACTIVE_COMPARATOR

JNJ-64417184

Intervention Type: DRUG

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

Interventions

JNJ-64417184

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

Intervention Type: DRUG

Eligibility 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:

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Janssen Pharmaceutica N.V., Belgium

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Pharmaceutica N.V., Belgium Clinical Trial

Role: STUDY_DIRECTOR

Janssen Pharmaceutica N.V., Belgium

Locations

CRS Clinical Research Services Kiel GmbH

Kiel, , Germany

APEX GmbH

München, , Germany

Countries

Germany

Other Identifiers

2019-004929-25

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

64417184RSV1008

Identifier Type: OTHER

Identifier Source: secondary_id

CR108800

Identifier Type: -

Identifier Source: org_study_id