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

January 27, 2020 updated by: Janssen Research & Development, LLC

A Phase 1, 4-Period, Crossover, Open-label Study in Healthy Volunteers to Assess the Effect of Different Types of Food on a Single-dose of JNJ-64417184 Administered as Tablets

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Groningen, Netherlands, 9728 NZ
        • PRA Health Sciences Onderzoekscentrum Groningen, locatie Martini

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Treatment Sequence 1
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
Participants will receive single dose of JNJ-64417184 as oral tablet.
Experimental: Treatment Sequence 2
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
Participants will receive single dose of JNJ-64417184 as oral tablet.
Experimental: Treatment Sequence 3
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
Participants will receive single dose of JNJ-64417184 as oral tablet.
Experimental: Treatment Sequence 4
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
Participants will receive single dose of JNJ-64417184 as oral tablet.
Experimental: Treatment Sequence 5
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
Participants will receive single dose of JNJ-64417184 as oral tablet.
Experimental: Treatment Sequence 6
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
Participants will receive single dose of JNJ-64417184 as oral tablet.
Experimental: Treatment Sequence 7
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
Participants will receive single dose of JNJ-64417184 as oral tablet.
Experimental: Treatment Sequence 8
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
Participants will receive single dose of JNJ-64417184 as oral tablet.
Experimental: Treatment Sequence 9
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
Participants will receive single dose of JNJ-64417184 as oral tablet.
Experimental: Treatment Sequence 10
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
Participants will receive single dose of JNJ-64417184 as oral tablet.
Experimental: Treatment Sequence 11
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
Participants will receive single dose of JNJ-64417184 as oral tablet.
Experimental: Treatment Sequence 12
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
Participants will receive single dose of JNJ-64417184 as oral tablet.
Experimental: Treatment Sequence 13
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
Participants will receive single dose of JNJ-64417184 as oral tablet.
Experimental: Treatment Sequence 14
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
Participants will receive single dose of JNJ-64417184 as oral tablet.
Experimental: Treatment Sequence 15
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
Participants will receive single dose of JNJ-64417184 as oral tablet.
Experimental: Treatment Sequence 16
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
Participants will receive single dose of JNJ-64417184 as oral tablet.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Plasma Concentration of JNJ-64417184 under Fasted and Fed (Low-fat meal, Ensure Original, Standard meal, and High-Fat Meal as a Reference) Conditions
Time Frame: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 120 hours postdose
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Plasma Concentration of JNJ-64417184 under Fasted and Fed (Low-fat meal, Ensure Original, Standard meal, Excluding High-fat Meal) Conditions
Time Frame: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 120 hours postdose
Plasma Concentration of JNJ-64417184 under Fasted and Fed (low-fat meal, Ensure Original, standard meal, and excluding high-fat meal) conditions will be determined.
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
Time Frame: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 120 hours postdose
Cmax is the maximum observed analyte concentration.
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
Time Frame: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 120 hours postdose
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.
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
Time Frame: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 120 hours postdose
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) plasma analyte concentration; extrapolations of more than 20% of the total AUC are reported as approximations, and lambda(z) is apparent terminal elimination rate constant.
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
Time Frame: Up to 28 Days
An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product does not necessarily have a causal relationship with the treatment. Therefore, it can be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to that medicinal product.
Up to 28 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Janssen Research & Development, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 8, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 23, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 23, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 8, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 8, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 9, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 28, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 27, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CR108707
  • 2019-003469-17 (EudraCT Number)
  • 64417184RSV1006 (Other Identifier: Janssen Research & Development, LLC)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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