A Study of JNJ-64417184, Administered as an Oral Solution, in Healthy Participants

NCT ID: NCT04258189

Last Updated: 2025-02-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-11
• Study Completion Date: 2020-08-05

Brief Summary

The purpose of this study is to assess the food effect on the single-dose pharmacokinetic (PK) of the JNJ-64417184 oral solution, administered as 2 different formulations, in healthy adult participants.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Panel 1: Treatment Sequence ABDC

Participants will receive Treatment A (a single dose of JNJ-64417184 \[oral solution with preservatives\] in fasted condition) in treatment Period 1; followed by Treatment B (a single dose of JNJ-64417184 \[oral solution with preservatives\] in fed \[high-fat meal\] condition) in treatment Period 2; followed by Treatment D (a single dose of JNJ-64417184 \[oral solution without preservatives\] in fed \[high-fat meal\] condition) in treatment Period 3, followed by Treatment C (a single dose of JNJ-64417184 \[oral solution without preservatives\] in fasted condition) in treatment Period 4 on Day 1 of each treatment period. A washout period of at least 7 days will be maintained between each study drug intakes.

Group Type: EXPERIMENTAL

JNJ-64417184

Intervention Type: DRUG

Single dose of JNJ-64417184 solution (with or without preservatives) will be administered orally.

Panel 1: Treatment Sequence BCAD

Participants will receive Treatment B in treatment Period 1; followed by Treatment C in treatment Period 2; followed by Treatment A in treatment Period 3, followed by Treatment D in treatment Period 4 on Day 1 of each treatment period. A washout period of at least 7 days will be maintained between each study drug intakes.

Group Type: EXPERIMENTAL

JNJ-64417184

Intervention Type: DRUG

Single dose of JNJ-64417184 solution (with or without preservatives) will be administered orally.

Panel 1: Treatment Sequence CDBA

Participants will receive Treatment C in treatment Period 1; followed by Treatment D in treatment Period 2; followed by Treatment B in treatment Period 3, followed by Treatment A in treatment Period 4 on Day 1 of each treatment period. A washout period of at least 7 days will be maintained between each study drug intakes.

Group Type: EXPERIMENTAL

JNJ-64417184

Intervention Type: DRUG

Single dose of JNJ-64417184 solution (with or without preservatives) will be administered orally.

Panel 1: Treatment Sequence DACB

Participants will receive Treatment D in treatment Period 1; followed by Treatment A in treatment Period 2; followed by Treatment C in treatment Period 3, followed by Treatment B in treatment Period 4 on Day 1 of each treatment period. A washout period of at least 7 days will be maintained between each study drug intakes.

Group Type: EXPERIMENTAL

JNJ-64417184

Intervention Type: DRUG

Single dose of JNJ-64417184 solution (with or without preservatives) will be administered orally.

Optional Panel 2: Treatment Sequence EFG

Participants will receive Treatment E (a single dose of JNJ-64417184 \[oral solution with or without preservatives\] in fasted condition) in treatment Period 1; followed by Treatment F (a single dose of JNJ-64417184 \[oral solution with or without preservatives\] in fed \[high-fat meal\] condition) in treatment Period 2; followed by Treatment G (a single dose of JNJ-64417184 \[oral solution with or without preservatives\] in fed \[high-fat meal\] condition) in treatment Period 3 on Day 1 of each treatment period. A washout period of at least 7 days will be maintained between each study drug intakes.

Group Type: EXPERIMENTAL

JNJ-64417184

Intervention Type: DRUG

Single dose of JNJ-64417184 solution (with or without preservatives) will be administered orally.

Optional Panel 2: Treatment Sequence FGE

Participants will receive Treatment F in treatment Period 1; followed by Treatment G in treatment Period 2; followed by Treatment E in treatment Period 3 on Day 1 of each treatment period. A washout period of at least 7 days will be maintained between each study drug intakes.

Group Type: EXPERIMENTAL

JNJ-64417184

Intervention Type: DRUG

Single dose of JNJ-64417184 solution (with or without preservatives) will be administered orally.

Optional Panel 2: Treatment Sequence GEF

Participants will receive Treatment G in treatment Period 1; followed by Treatment E in treatment Period 2; followed by Treatment F in treatment Period 3 on Day 1 of each treatment period. A washout period of at least 7 days will be maintained between each study drug intakes.

Group Type: EXPERIMENTAL

JNJ-64417184

Intervention Type: DRUG

Single dose of JNJ-64417184 solution (with or without preservatives) will be administered orally.

Optional Panel 2: Treatment Sequence GFE

Participants will receive Treatment G in treatment Period 1; followed by Treatment F in treatment Period 2; followed by Treatment E in treatment Period 3 on Day 1 of each treatment period. A washout period of at least 7 days will be maintained between each study drug intakes.

Group Type: EXPERIMENTAL

JNJ-64417184

Intervention Type: DRUG

Single dose of JNJ-64417184 solution (with or without preservatives) will be administered orally.

Optional Panel 2: Treatment Sequence EGF

Participants will receive Treatment E in treatment Period 1; followed by Treatment G in treatment Period 2; followed by Treatment F in treatment Period 3 on Day 1 of each treatment period. A washout period of at least 7 days will be maintained between each study drug intakes.

Group Type: EXPERIMENTAL

JNJ-64417184

Intervention Type: DRUG

Single dose of JNJ-64417184 solution (with or without preservatives) will be administered orally.

Optional Panel 2: Treatment Sequence FEG

Participants will receive Treatment F in treatment Period 1; followed by Treatment E in treatment Period 2; followed by Treatment G in treatment Period 3 on Day 1 of each treatment period. A washout period of at least 7 days will be maintained between each study drug intakes.

Group Type: EXPERIMENTAL

JNJ-64417184

Intervention Type: DRUG

Single dose of JNJ-64417184 solution (with or without preservatives) will be administered orally.

Interventions

JNJ-64417184

Single dose of JNJ-64417184 solution (with or without preservatives) will be administered orally.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Must have a body mass index (BMI; weight [kg]/height^2 [m^2]) between 18.0 and 30.0 kilogram per meter square (kg/m^2), extremes included, and a body weight not less than 50.0 kg at screening
• 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
• Healthy on the basis of clinical laboratory tests performed at screening
• Must have a normal 12-lead electrocardiogram (ECG) (triplicate) at screening
• Female participant must have a negative highly sensitive serum beta-human chorionic gonadotropin (beta- hCG) pregnancy test at screening and a negative urine pregnancy test on Day -1

Exclusion Criteria

• History of liver or renal dysfunction significant cardiac, vascular, pulmonary, gastrointestinal (such as significant diarrhea, gastric stasis, or constipation that in the investigator's opinion could influence drug absorption or bioavailability), endocrine, neurologic, hematologic, rheumatologic, psychiatric, neoplastic, or metabolic disturbances
• Past history of cardiac arrhythmias (example, extrasystoli, tachycardia at rest), history of risk factors for Torsade de Pointes syndrome (example, hypokalemia, family history of long QT Syndrome)
• Any evidence of 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
• A history of clinically significant drug allergy such as, but not limited to, sulfonamides and penicillins, or drug allergy witnessed in previous studies with experimental drugs

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

Clinical Pharmacology Unit

Merksem, , Belgium

Countries

Belgium

Other Identifiers

CR108752

Identifier Type: -

Identifier Source: org_study_id

2019-004189-16

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

64417184RSV1007

Identifier Type: OTHER

Identifier Source: secondary_id