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

NCT04258189 | Completed Phase 1

• 3 other identifiers: CR1087522019-004189-1664417184RSV1007
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• Maximum Observed Plasma Analyte Concentration (Cmax) of JNJ-64417184

  Cmax is the maximum observed plasma analyte concentration.

  Up to Day 6

• Area Under the Concentration-time Curve from Time Zero to the Last Measurable Concentration (AUC [0-last]) of JNJ-64417184

  AUC (0-last) is area under the plasma analyte concentration-time curve (AUC) from time 0 to time of the last quantifiable (non-below quantification limit \[non-BQL\]) concentration, calculated by linear-linear trapezoidal summation.

  Up to Day 6

• Area Under the Concentration-time Curve from Time Zero to Infinity (AUC [0-infinity]) of JNJ-64417184

  AUC (0-infinity) is the area under the plasma analyte concentration-time curve (AUC) from time zero to infinite time, calculated as the sum of AUC (0-last) and C(last)/lambda(z); wherein AUC (0-last) is area under the plasma concentration-time curve from time zero to last measurable concentration, C(last) is the last observed measurable (non-BQL) analyte concentration; and lambda(z) is apparent terminal elimination rate constant.

  Up to Day 6

Secondary Outcomes (2)

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

  Up to 28 days

• Acceptability of the JNJ-64417184 Formulation as Assessed by Participant

  Up to 28 days

Study Arms (10)

Panel 1: Treatment Sequence ABDC

EXPERIMENTAL

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.

Drug: JNJ-64417184

Panel 1: Treatment Sequence BCAD

EXPERIMENTAL

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.

Drug: JNJ-64417184

Panel 1: Treatment Sequence CDBA

EXPERIMENTAL

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.

Drug: JNJ-64417184

Panel 1: Treatment Sequence DACB

EXPERIMENTAL

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.

Drug: JNJ-64417184

Optional Panel 2: Treatment Sequence EFG

EXPERIMENTAL

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.

Drug: JNJ-64417184

Optional Panel 2: Treatment Sequence FGE

EXPERIMENTAL

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.

Drug: JNJ-64417184

Optional Panel 2: Treatment Sequence GEF

EXPERIMENTAL

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.

Drug: JNJ-64417184

Optional Panel 2: Treatment Sequence GFE

EXPERIMENTAL

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.

Drug: JNJ-64417184

Optional Panel 2: Treatment Sequence EGF

EXPERIMENTAL

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.

Drug: JNJ-64417184

Optional Panel 2: Treatment Sequence FEG

EXPERIMENTAL

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.

Drug: JNJ-64417184

Interventions

JNJ-64417184 DRUG

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

Optional Panel 2: Treatment Sequence EFG; Optional Panel 2: Treatment Sequence EGF; Optional Panel 2: Treatment Sequence FEG; Optional Panel 2: Treatment Sequence FGE; Optional Panel 2: Treatment Sequence GEF; Optional Panel 2: Treatment Sequence GFE; Panel 1: Treatment Sequence ABDC; Panel 1: Treatment Sequence BCAD; Panel 1: Treatment Sequence CDBA; Panel 1: Treatment Sequence DACB

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (1)

Clinical Pharmacology Unit

Merksem, 2170, Belgium

Location

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2020
• First Posted: February 6, 2020
• Study Start: February 11, 2020
• Primary Completion: August 5, 2020
• Study Completion: August 5, 2020
• Last Updated: February 3, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share

Locations

BE (1)