A Study of JNJ-64281802 in Healthy Adult Participants

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: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: JNJ-64281802

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Maximum Observed Plasma Concentration (Cmax) of JNJ-64281802	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	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)	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	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	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	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	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	CL/F is defined as total apparent oral clearance of JNJ-64281802.	Up to Day 62

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Adverse Events (AEs)	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)	Number of participants with abnormalities in 12-lead ECGs will be reported.	Up to 62 days
Number of Participants with Abnormalities in Physical Examinations	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	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	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

• Sponsor: Janssen Research & Development, LLC
• Investigators: Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Study record dates

Study Major Dates

• Study Start (Actual): February 23, 2022
• Primary Completion (Actual): December 11, 2022
• Study Completion (Actual): December 11, 2022

Study Registration Dates

• First Submitted: January 12, 2022
• First Submitted That Met QC Criteria: January 12, 2022
• First Posted (Actual): January 21, 2022

Study Record Updates

• Last Update Posted (Actual): March 30, 2025
• Last Update Submitted That Met QC Criteria: March 28, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Other Study ID 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