A Study of JNJ-64281802 in Healthy Adult Participants

March 28, 2025 updated by: Janssen Research & Development, LLC

A Phase 1, Open-Label Study in Healthy Adult Participants to Assess the Pharmacokinetics of JNJ-64281802 Administered as Different Multiple Dose Regimens

The purpose of this study is to assess the pharmacokinetics (PK) of JNJ-64281802 in healthy participants when administered in different multiple dose regimens and as different dose strengths.

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.
33

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

Yes

Description

Inclusion Criteria:

  • Healthy on the basis of physical examination, medical history (at screening only), and vital signs performed at screening and Day -1. 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
  • Body weight not less than 50 kilogram (kg) and body mass index (BMI) within the range 18.0 and 30.0 kilogram per meter square (kg/m^2), extremes included, at screening and Day -1
  • All women must have a negative highly sensitive serum (beta human chorionic gonadotropin [beta hCG]) at screening and a negative urine pregnancy test at Day -1
  • Contraceptive use should be consistent with local regulations regarding the use of contraceptive methods for participant participating in clinical studies
  • Must sign an informed consent form (ICF) indicating that the participant understands the purpose of, and procedures required for, the study and is willing to participate in the study, before starting any screening activities

Exclusion Criteria:

  • Any history of clinically significant skin disease such as, but not limited to, dermatitis, eczema, drug rash, psoriasis, food allergy, and urticaria
  • Known allergies, hypersensitivity, or intolerance to JNJ-64281802 or its excipients
  • Has been dosed with JNJ-64281802 in past 3 months
  • Current human immunodeficiency virus type 1 (HIV-1) or type 2 (HIV-2) infection (confirmed by antibodies) at screening
  • Current Coronavirus disease 2019 (COVID-19) infection (confirmed by severe acute respiratory syndrome coronavirus 2 [SARS-CoV2] polymerase chain reaction [PCR]) at the time of admission to the study site (Day -1)

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: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel 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: Arm A: Panel 1 (JNJ-64281802 High Dose Regimen)
Participants will receive Loading Dose (LD) 1 of JNJ-64281802 twice daily on Days 1 and 2 followed by maintenance Dose (MD) 1 of JNJ-64281802 once daily on Days 3, 10, 17 and 24.
Drug: JNJ-64281802
JNJ-64281802 tablets will be administered orally as per the defined regimens.
Experimental: Arm A: Panel 2 (JNJ-64281802 High Dose Regimen)
Participants will receive LD 1 of JNJ-64281802 twice daily on Days 1 and 2 followed by MD 2 of JNJ-64281802 once daily on Days 3, 6, 10, 13, 17, 20, 24, and 27.
Drug: JNJ-64281802
JNJ-64281802 tablets will be administered orally as per the defined regimens.
Experimental: Arm B: Panel 3 (JNJ-64281802 Low Dose Regimen)
Participants will receive LD 2 of JNJ-64281802 twice daily on Days 1 and 2 followed by MD 3 of JNJ-64281802 once daily on Days 3, 10, 17 and 24.
Drug: JNJ-64281802
JNJ-64281802 tablets will be administered orally as per the defined regimens.
Experimental: Arm B: Panel 4 (JNJ-64281802 Low Dose Regimen)
Participants will receive LD 2 of JNJ-64281802 twice daily on Days 1 and 2 followed by MD 4 of JNJ-64281802 once daily on Days 3, 6, 10, 13, 17, 20, 24, and 27.
Drug: JNJ-64281802
JNJ-64281802 tablets will be administered orally as per the defined regimens.
Experimental: Arm C: Panel 5 (JNJ-64281802 [Optional])
Participants dosing regimen(s) will be determined based on the results of Study Arm A and Study Arm B.
Drug: JNJ-64281802
JNJ-64281802 tablets will be administered orally as per the defined regimens.
Experimental: Arm C: Panel 6 (JNJ-64281802 [Optional])
Participants dosing regimen(s) will be determined based on the results of Study Arm A and Study Arm B.
Drug: JNJ-64281802
JNJ-64281802 tablets will be administered orally as per the defined regimens.

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
Maximum Observed Plasma Concentration (Cmax) of JNJ-64281802
Time Frame: Up to Day 62
Cmax is defined as maximum observed plasma concentration of JNJ-64281802.
Up to Day 62
Time to Reach the Maximum Observed Plasma Concentration (Tmax) of JNJ-64281802
Time Frame: Up to Day 62
Tmax is defined the actual sampling time to reach the maximum observed plasma concentration of JNJ-64281802.
Up to Day 62
Observed Plasma Concentration of JNJ-64281802 Just Prior to the Beginning of a Dosing Interval (Ctrough)
Time Frame: Up to Day 62
Ctrough is defined as observed plasma concentration of JNJ-64281802 just prior to the beginning of a dosing interval.
Up to Day 62
Apparent Terminal Elimination Half-life (t1/2) of JNJ-64281802
Time Frame: Up to Day 62
t1/2 is defined as apparent terminal elimination half-life of JNJ-64281802.
Up to Day 62
Area Under the Curve From Time Zero to Last Measurable Concentration (AUC[0-last]) of JNJ-64281802
Time Frame: Up to Day 62
AUC(0-last) is defined as area under the curve from time 0 to the time of the last measurable concentration of JNJ-64281802.
Up to Day 62
Area Under the Curve From Time Zero to Infinity (AUC[0-inf]) of JNJ-64281802
Time Frame: Up to Day 62
AUC(0-inf) is defined as area under the curve of JNJ-64281802 from time 0 to infinity time.
Up to Day 62
Area Under the Curve From Time Zero to tau (AUC[0-tau]) of JNJ-64281802
Time Frame: Up to Day 62
AUC(0-tau) is defined as area under the curve from time 0 to tau hours post dose of JNJ-64281802.
Up to Day 62
Total Apparent Oral Clearance (CL/F) of JNJ-64281802
Time Frame: Up to Day 62
CL/F is defined as total apparent oral clearance of JNJ-64281802.
Up to Day 62

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
Number of Participants with Adverse Events (AEs)
Time Frame: Up to 62 days
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
Up to 62 days
Number of Participants with Abnormalities in 12-lead Electrocardiograms (ECGs)
Time Frame: Up to 62 days
Number of participants with abnormalities in 12-lead ECGs will be reported.
Up to 62 days
Number of Participants with Abnormalities in Physical Examinations
Time Frame: Up to 62 days
Number of participants with abnormalities in physical examinations (including skin examination, height and body weight) will be reported.
Up to 62 days
Number of Participants with Abnormalities in Vital Sign Measurements
Time Frame: Up to 62 days
Number of participants with abnormalities in vital sign measurements (including temperature, temporal artery measurements, pulse/heart rate and blood pressure) will be reported.
Up to 62 days
Number of Participants with Abnormalities in Clinical Laboratory Tests
Time Frame: Up to 62 days
Number of participants with abnormalities in clinical laboratory tests (including hematology, serum chemistry and urinalysis) will be reported.
Up to 62 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

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Janssen Research & Development, LLC Clinical Trial, 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.
February 23, 2022

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 11, 2022

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 11, 2022

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).
January 12, 2022

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.
January 12, 2022

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.
January 21, 2022

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.
March 30, 2025

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.
March 28, 2025

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.
March 1, 2025

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.
  • CR109139
  • 2021-005574-25 (EudraCT Number)
  • 64281802DNG1008 (Other Identifier: Janssen Research and 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings