A Study of JNJ-64281802 in Healthy Adult Participants

NCT05201937 | Completed Phase 1

• 3 other identifiers: CR1091392021-005574-2564281802DNG1008
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (5)

• Number of Participants with Adverse Events (AEs)

  Up to 62 days

• Number of Participants with Abnormalities in 12-lead Electrocardiograms (ECGs)

  Up to 62 days

• Number of Participants with Abnormalities in Physical Examinations

  Up to 62 days

• Number of Participants with Abnormalities in Vital Sign Measurements

  Up to 62 days

• Number of Participants with Abnormalities in Clinical Laboratory Tests

  Up to 62 days

Study Arms (6)

Arm A: Panel 1 (JNJ-64281802 High Dose Regimen)

EXPERIMENTAL

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

Arm A: Panel 2 (JNJ-64281802 High Dose Regimen)

EXPERIMENTAL

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

Arm B: Panel 3 (JNJ-64281802 Low Dose Regimen)

EXPERIMENTAL

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

Arm B: Panel 4 (JNJ-64281802 Low Dose Regimen)

EXPERIMENTAL

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

Arm C: Panel 5 (JNJ-64281802 [Optional])

EXPERIMENTAL

Participants dosing regimen(s) will be determined based on the results of Study Arm A and Study Arm B.

Drug: JNJ-64281802

Arm C: Panel 6 (JNJ-64281802 [Optional])

EXPERIMENTAL

Participants dosing regimen(s) will be determined based on the results of Study Arm A and Study Arm B.

Drug: JNJ-64281802

Interventions

JNJ-64281802 DRUG

JNJ-64281802 tablets will be administered orally as per the defined regimens.

Arm A: Panel 1 (JNJ-64281802 High Dose Regimen); Arm A: Panel 2 (JNJ-64281802 High Dose Regimen); Arm B: Panel 3 (JNJ-64281802 Low Dose Regimen); Arm B: Panel 4 (JNJ-64281802 Low Dose Regimen); Arm C: Panel 5 (JNJ-64281802 [Optional]); Arm C: Panel 6 (JNJ-64281802 [Optional])

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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)

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: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2022
• First Posted: January 21, 2022
• Study Start: February 23, 2022
• Primary Completion: December 11, 2022
• Study Completion: December 11, 2022
• Last Updated: March 30, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share

Locations

NL (1)