A Study of JNJ-64281802 in Healthy Adult Participants

Study Overview
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Brief Summary
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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.

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

Conditions
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Healthy

Intervention / Treatment
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* Drug: JNJ-64281802


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A: Panel 1 (JNJ-64281802 High Dose Regimen)<br>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<br>* JNJ-64281802 tablets will be administered orally as per the defined regimens.<br>|
| Experimental: Arm A: Panel 2 (JNJ-64281802 High Dose Regimen)<br>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<br>* JNJ-64281802 tablets will be administered orally as per the defined regimens.<br>|
| Experimental: Arm B: Panel 3 (JNJ-64281802 Low Dose Regimen)<br>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<br>* JNJ-64281802 tablets will be administered orally as per the defined regimens.<br>|
| Experimental: Arm B: Panel 4 (JNJ-64281802 Low Dose Regimen)<br>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<br>* JNJ-64281802 tablets will be administered orally as per the defined regimens.<br>|
| Experimental: Arm C: Panel 5 (JNJ-64281802 [Optional])<br>Participants dosing regimen(s) will be determined based on the results of Study Arm A and Study Arm B. | Drug: JNJ-64281802<br>* JNJ-64281802 tablets will be administered orally as per the defined regimens.<br>|
| Experimental: Arm C: Panel 6 (JNJ-64281802 [Optional])<br>Participants dosing regimen(s) will be determined based on the results of Study Arm A and Study Arm B. | Drug: JNJ-64281802<br>* JNJ-64281802 tablets will be administered orally as per the defined regimens.<br>|

What is the study measuring?
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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 |