HealthyPhase 1NCT05201937
A Study of JNJ-64281802 in Healthy Adult Participants
A Phase 1 study testing JNJ-64281802 in people with Healthy, run by Janssen Research & Development, LLC at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- JNJ-64281802
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteNetherlands
- Study dates
- 23 Feb 2022to 11 Dec 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
PRA Health Sciences Onderzoekscentrum Groningen, locatie Martini
Groningen, 9728 NZ
About this study
Official title: 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.
- Conditions
- Healthy
- Being tested
- JNJ-64281802
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JNJ-64281802Drug
JNJ-64281802 tablets will be administered orally as per the defined regimens.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: JNJ-64281802 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed Plasma Concentration (Cmax) of JNJ-64281802
Cmax is defined as maximum observed plasma concentration of JNJ-64281802.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to Day 62
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 62 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2022
- Study start23 Feb 2022
- Primary completion11 Dec 2022
- Study completion11 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05201937
- Sponsor's protocol ID
- CR109139
- Other IDs
- 2021-005574-25, 64281802DNG1008
- Status last verified
- Mar 2025
- First submitted
- 12 Jan 2022
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label Study in Healthy Adult Participants to Assess the Pharmacokinetics of JNJ-64281802 Administered as Different Multiple Dose Regimens
- ClinicalTrials.gov ID
- NCT05201937
- Acronym / sponsor ID
- CR109139
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 23 Feb 2022 (actual)
- Primary completion
- 11 Dec 2022 (actual)
- Study completion
- 11 Dec 2022 (actual)
- First posted
- 21 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Arm A: Panel 1 (JNJ-64281802 High Dose Regimen) | Experimental | Drug: JNJ-64281802Participants 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. |
| Arm A: Panel 2 (JNJ-64281802 High Dose Regimen) | Experimental | Drug: JNJ-64281802Participants 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. |
| Arm B: Panel 3 (JNJ-64281802 Low Dose Regimen) | Experimental | Drug: JNJ-64281802Participants 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. |
| Arm B: Panel 4 (JNJ-64281802 Low Dose Regimen) | Experimental | Drug: JNJ-64281802Participants 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. |
| Arm C: Panel 5 (JNJ-64281802 [Optional]) | Experimental | Drug: JNJ-64281802Participants dosing regimen(s) will be determined based on the results of Study Arm A and Study Arm B. |
| Arm C: Panel 6 (JNJ-64281802 [Optional]) | Experimental | Drug: JNJ-64281802Participants dosing regimen(s) will be determined based on the results of Study Arm A and Study Arm B. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JNJ-64281802JNJ-64281802 tablets will be administered orally as per the defined regimens. | Drug | 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]) |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
5 secondary outcomes
Number of Participants with Adverse Events (AEs)
Time frame: 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 Physical Examinations
Time frame: 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 Clinical Laboratory Tests
Time frame: Up to 62 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2025.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Research & Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing JNJ-64281802 in people with Healthy, run by Janssen Research & Development, LLC at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Observed Plasma Concentration (Cmax) of JNJ-64281802 (time frame: Up to Day 62). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2025.