Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
33 participants
INTERVENTIONAL
2022-02-23
2022-12-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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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.
JNJ-64281802
JNJ-64281802 tablets will be administered orally as per the defined regimens.
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.
JNJ-64281802
JNJ-64281802 tablets will be administered orally as per the defined regimens.
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.
JNJ-64281802
JNJ-64281802 tablets will be administered orally as per the defined regimens.
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.
JNJ-64281802
JNJ-64281802 tablets will be administered orally as per the defined regimens.
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.
JNJ-64281802
JNJ-64281802 tablets will be administered orally as per the defined regimens.
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.
JNJ-64281802
JNJ-64281802 tablets will be administered orally as per the defined regimens.
Interventions
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JNJ-64281802
JNJ-64281802 tablets will be administered orally as per the defined regimens.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
55 Years
ALL
Yes
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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PRA Health Sciences Onderzoekscentrum Groningen, locatie Martini
Groningen, , Netherlands
Countries
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Other Identifiers
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2021-005574-25
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
64281802DNG1008
Identifier Type: OTHER
Identifier Source: secondary_id
CR109139
Identifier Type: -
Identifier Source: org_study_id
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