A Study in Healthy Volunteers to Assess the Effect of Different Types of Food on a Single-dose of JNJ-64417184 Administered as Tablets

NCT04121052 | Completed Phase 1

• 3 other identifiers: CR1087072019-003469-1764417184RSV1006
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the effect of 5 different food conditions on the single dose pharmacokinetics (PK) of the JNJ-64417184 tablet formulation administered orally, using the PK after a high-fat meal as a reference, in healthy adult participants.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Plasma Concentration of JNJ-64417184 under Fasted and Fed (Low-fat meal, Ensure Original, Standard meal, and High-Fat Meal as a Reference) Conditions

  Plasma concentration of JNJ-64417184 under fasted and fed (low-fat meal, Ensure Original, standard meal, and high-fat meal as a reference) conditions will be determined.

  Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 120 hours postdose

Secondary Outcomes (5)

• Plasma Concentration of JNJ-64417184 under Fasted and Fed (Low-fat meal, Ensure Original, Standard meal, Excluding High-fat Meal) Conditions

  Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 120 hours postdose

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

  Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 120 hours postdose

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

  Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 120 hours postdose

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

  Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 120 hours postdose

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

  Up to 28 Days

Study Arms (16)

Treatment Sequence 1

EXPERIMENTAL

Participants will receive JNJ-64417184 oral tablet in fed conditions (high-fat meal) in treatment period 1; followed by JNJ-64417184 oral tablet in fed conditions (low-fat meal) in treatment period 2; followed by JNJ-64417184 oral tablet in fed conditions (Ensure Original) in treatment period 3; followed by JNJ-64417184 oral tablet in fed conditions (standard meal) in treatment period 4, on Day 1 of each treatment period. A washout period of at least 7 days will be maintained between each treatment period.

Drug: JNJ-64417184

Treatment Sequence 2

EXPERIMENTAL

Participants will receive JNJ-64417184 oral tablet in fed conditions (low-fat meal) in treatment period 1; followed by JNJ-64417184 oral tablet in fed conditions (standard meal) in treatment period 2; followed by JNJ-64417184 oral tablet in fed conditions (high-fat meal) in treatment period 3; followed by JNJ-64417184 oral tablet in fed conditions (Ensure Original) in treatment period 4, on Day 1 of each treatment period. A washout period of at least 7 days will be maintained between each treatment period.

Drug: JNJ-64417184

Treatment Sequence 3

EXPERIMENTAL

Participants will receive JNJ-64417184 oral tablet in fed conditions (standard meal) in treatment period 1; followed by JNJ-64417184 oral tablet in fed conditions (Ensure Original) in treatment period 2; followed by JNJ-64417184 oral tablet in fed conditions (low-fat meal) in treatment period 3; followed by JNJ-64417184 oral tablet in fed conditions (high-fat meal) in treatment period 4, on Day 1 of each treatment period. A washout period of at least 7 days will be maintained between each treatment period.

Drug: JNJ-64417184

Treatment Sequence 4

EXPERIMENTAL

Participants will receive JNJ-64417184 oral tablet in fed conditions (Ensure Original) in treatment period 1; followed by JNJ-64417184 oral tablet in fed conditions (high-fat meal) in treatment period 2; followed by JNJ-64417184 oral tablet in fed conditions (standard meal) in treatment period 3; followed by JNJ-64417184 oral tablet in fed conditions (low-fat meal) in treatment period 4, on Day 1 of each treatment period. A washout period of at least 7 days will be maintained between each treatment period.

Drug: JNJ-64417184

Treatment Sequence 5

EXPERIMENTAL

Participants will receive JNJ-64417184 oral tablet in fed conditions (high-fat meal) in treatment period 1; followed by JNJ-64417184 oral tablet in fed conditions (low-fat meal) in treatment period 2; followed by JNJ-64417184 oral tablet under fasted condition in treatment period 3; followed by JNJ-64417184 oral tablet in fed conditions (standard meal) in treatment period 4, on Day 1 of each treatment period. A washout period of at least 7 days will be maintained between each treatment period.

Drug: JNJ-64417184

Treatment Sequence 6

EXPERIMENTAL

Participants will receive JNJ-64417184 oral tablet in fed conditions (low-fat meal) in treatment period 1; followed by JNJ-64417184 oral tablet in fed conditions (standard meal) in treatment period 2; followed by JNJ-64417184 oral tablet in fed conditions (high-fat meal) in treatment period 3; followed by JNJ-64417184 oral tablet under 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 treatment period.

Drug: JNJ-64417184

Treatment Sequence 7

EXPERIMENTAL

Participants will receive JNJ-64417184 oral tablet in fed conditions (standard meal) in treatment period 1; followed by JNJ-64417184 oral tablet under fasted condition in treatment period 2; followed by JNJ-64417184 oral tablet in fed conditions (low-fat meal) in treatment period 3; followed by JNJ-64417184 oral tablet in fed conditions (high-fat meal) in treatment period 4, on Day 1 of each treatment period. A washout period of at least 7 days will be maintained between each treatment period.

Drug: JNJ-64417184

Treatment Sequence 8

EXPERIMENTAL

Participants will receive JNJ-64417184 oral tablet under fasted condition in treatment period 1; followed by JNJ-64417184 oral tablet in fed conditions (high-fat meal) in treatment period 2; followed by JNJ-64417184 oral tablet in fed conditions (standard meal) in treatment period 3; followed by JNJ-64417184 oral tablet in fed conditions (low-fat meal) in treatment period 4, on Day 1 of each treatment period. A washout period of at least 7 days will be maintained between each treatment period.

Drug: JNJ-64417184

Treatment Sequence 9

EXPERIMENTAL

Participants will receive JNJ-64417184 oral tablet in fed conditions (high-fat meal) in treatment period 1; followed by JNJ-64417184 oral tablet in fed conditions (low-fat meal) in treatment period 2; followed by JNJ-64417184 oral tablet under fasted condition in treatment period 3; followed by JNJ-64417184 oral tablet in fed conditions (Ensure Original) in treatment period 4, on Day 1 of each treatment period. A washout period of at least 7 days will be maintained between each treatment period.

Drug: JNJ-64417184

Treatment Sequence 10

EXPERIMENTAL

Participants will receive JNJ-64417184 oral tablet in fed conditions (low-fat meal) in treatment period 1; followed by JNJ-64417184 oral tablet in fed conditions (Ensure Original) in treatment period 2; followed by JNJ-64417184 oral tablet in fed conditions (high-fat meal) in treatment period 3; followed by JNJ-64417184 oral tablet under 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 treatment period.

Drug: JNJ-64417184

Treatment Sequence 11

EXPERIMENTAL

Participants will receive JNJ-64417184 oral tablet in fed conditions (Ensure Original) in treatment period 1; followed by JNJ-64417184 oral tablet under fasted condition in treatment period 2; followed by JNJ-64417184 oral tablet in fed conditions (low-fat meal) in treatment period 3; followed by JNJ-64417184 oral tablet in fed conditions (high-fat meal) in treatment period 4, on Day 1 of each treatment period. A washout period of at least 7 days will be maintained between each treatment period.

Drug: JNJ-64417184

Treatment Sequence 12

EXPERIMENTAL

Participants will receive JNJ-64417184 oral tablet under fasted condition in treatment period 1; followed by JNJ-64417184 oral tablet in fed conditions (high-fat meal) in treatment period 2; followed by JNJ-64417184 oral tablet in fed conditions (Ensure Original) in treatment period 3; followed by JNJ-64417184 oral tablet in fed conditions ( low-fat meal) in treatment period 4, on Day 1 of each treatment period. A washout period of at least 7 days will be maintained between each treatment period.

Drug: JNJ-64417184

Treatment Sequence 13

EXPERIMENTAL

Participants will receive JNJ-64417184 oral tablet in fed conditions (high-fat meal) in treatment period 1; followed by JNJ-64417184 oral tablet in fed conditions (standard meal) in treatment period 2; followed by JNJ-64417184 oral tablet under fasted condition in treatment period 3; followed by JNJ-64417184 oral tablet in fed conditions (Ensure Original) in treatment period 4, on Day 1 of each treatment period. A washout period of at least 7 days will be maintained between each treatment period.

Drug: JNJ-64417184

Treatment Sequence 14

EXPERIMENTAL

Participants will receive JNJ-64417184 oral tablet in fed conditions (standard meal) in treatment period 1; followed by JNJ-64417184 oral tablet in fed conditions (Ensure Original) in treatment period 2; followed by JNJ-64417184 oral tablet in fed conditions (high-fat meal) in treatment period 3; followed by JNJ-64417184 oral tablet under 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 treatment period.

Drug: JNJ-64417184

Treatment Sequence 15

EXPERIMENTAL

Participants will receive JNJ-64417184 oral tablet in fed conditions (Ensure Original) in treatment period 1; followed by JNJ-64417184 oral tablet under fasted condition in treatment period 2; followed by JNJ-64417184 oral tablet in fed conditions (standard meal) in treatment period 3; followed by JNJ-64417184 oral tablet in fed conditions (high-fat meal) in treatment period 4, on Day 1 of each treatment period. A washout period of at least 7 days will be maintained between each treatment period.

Drug: JNJ-64417184

Treatment Sequence 16

EXPERIMENTAL

Participants will receive JNJ-64417184 oral tablet under fasted condition in treatment period 1; followed by JNJ-64417184 oral tablet in fed conditions (high-fat meal) in treatment period 2; followed by JNJ-64417184 oral tablet in fed conditions (Ensure Original) in treatment period 3; followed by JNJ-64417184 oral tablet in fed conditions (standard meal) in treatment period 4, on Day 1 of each treatment period. A washout period of at least 7 days will be maintained between each treatment period.

Drug: JNJ-64417184

Interventions

JNJ-64417184 DRUG

Participants will receive single dose of JNJ-64417184 as oral tablet.

Treatment Sequence 1; Treatment Sequence 10; Treatment Sequence 11; Treatment Sequence 12; Treatment Sequence 13; Treatment Sequence 14; Treatment Sequence 15; Treatment Sequence 16; Treatment Sequence 2; Treatment Sequence 3; Treatment Sequence 4; Treatment Sequence 5; Treatment Sequence 6; Treatment Sequence 7; Treatment Sequence 8; Treatment Sequence 9

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 per height square between 18.0 and 30.0 kilogram per meter square (kg/m\^2), (extremes included), and 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. This determination must be recorded in the participant's source documents and initialed by the investigator
• Must have a normal 12-lead electrocardiogram (ECG) (triplicate) at screening, including: normal sinus rhythm (heart rate between 45 and 100 beats per minute \[bpm\], extremes included); QT interval corrected for heart rate (QTc); QRS interval less than (\<) 120 milliseconds (ms); PR interval less than or equals to \<= 200 ms. If the results of the ECG are outside the normal ranges, the subject may be included only if the investigator judges the deviations from normal ECG to be not clinically significant or to be appropriate and reasonable for the population under study. This determination must be recorded in the subject's source documents and initialed by the investigator
• Female participant must have a negative highly sensitive serum beta human chorionic gonadotropin (Beta-hCG) pregnancy test at screening and on Days -1 for each treatment period (except for postmenopausal female participants)
• Must not use nicotine-containing substances including tobacco products (example, cigarettes, e-cigarettes, cigars, chewing tobacco, gum, or patch) for at least 3 months prior to screening

You may not qualify if:

• Any evidence of heart block or bundle branch block at screening
• Current human immunodeficiency virus (HIV)-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 HBV infection (confirmed by hepatitis B surface antigen), or HCV infection (confirmed by HCV antibody) 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
• Has previously been dosed with JNJ-64417184

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (1)

PRA Health Sciences Onderzoekscentrum Groningen, locatie Martini

Groningen, 9728 NZ, Netherlands

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: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2019
• First Posted: October 9, 2019
• Study Start: October 8, 2019
• Primary Completion: December 23, 2019
• Study Completion: December 23, 2019
• Last Updated: January 28, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will share

Locations

NL (1)