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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-005574-25 | EudraCT Number | ||
| 64281802DNG1008 | Other Identifier | Janssen Research and development, LLC |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ-64281802 | Drug | JNJ-64281802 tablets will be administered orally as per the defined regimens. |
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| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PRA Health Sciences Onderzoekscentrum Groningen, locatie Martini | Groningen | 9728 NZ | Netherlands |
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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| 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. |
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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 |
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 |