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| ID | Type | Description | Link |
|---|---|---|---|
| 88260237CKD1001 | Other Identifier | Janssen Research & Development, LLC |
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The purpose of this study is to assess the safety and tolerability of a single oral dose of JNJ-88260237 in healthy participants
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JNJ-88260237 | Experimental | Participants will be randomized into 6 cohorts to receive single oral dose of JNJ-88260237 on Day 1. The doses in each cohort (Cohorts 2 to 4 and 6) will be escalated based on the safety and pharmacokinetics (PK) data of the previous cohort. For Cohort 5, participants will receive a single-dose of JNJ-82260237 in fasted conditions and a single dose of JNJ-82260237 in fed conditions with dosing sequence determined by randomization. |
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| Placebo | Placebo Comparator | Participants in Cohorts 1 to 4 and 6 will receive single oral dose of matching placebo on Day 1. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ-88260237 | Drug | JNJ-88260237 will be administered orally. |
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| Measure | Description | Time Frame |
|---|---|---|
| Cohort 1 to 4 and Cohort 6: Number of Participants with Adverse Events (AEs) | Number of participants with AEs will be reported. | Up to Day 14 |
| Cohort 5: Number of Participants with Adverse Events (AEs) | Number of participants with AEs will be reported. | Up to Day 24 |
| Cohort 1 to 4 and Cohort 6: Number of Participants with Abnormalities in Vital Signs | Number of participants with abnormalities in vital signs (including body temperature, pulse rate, respiratory rate, and blood pressure) will be reported. | Up to Day 7 |
| Cohort 5: Number of Participants with Abnormalities in Vital Signs | Number of participants with abnormalities in vital signs (including body temperature, pulse rate, respiratory rate, and blood pressure) will be reported. | Up to Day 21 |
| Cohort 1 to 4 and Cohort 6: Number of Participants with Abnormalities in Electrocardiogram (ECG) | Number of participants with abnormalities in ECGs (digital 12-lead ECGs/Holter ECGs) will be reported. | Up to Day 7 |
| Cohort 5: Number of Participants with Abnormalities in Electrocardiogram (ECG) | Number of participants with abnormalities in ECGs (digital 12-lead ECGs/Holter ECGs) will be reported. | Up to Day 21 |
| Cohort 1 to 4 and Cohort 6: Number of Participants with Abnormalities in Clinical Safety Laboratory Parameters |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Whole Blood Concentration (Cmax) of JNJ-88260237 | Cmax is defined as the maximum whole blood concentration of JNJ-88260237. | Cohort 1 to 4 and Cohort 6: Up to Day 7; Cohort 5: Up to day 21 |
| Time to Reach the Maximum Whole Blood Concentration (Tmax) of JNJ-88260237 |
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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 |
|---|---|---|---|---|---|---|
| Celerion | Lincoln | Nebraska | 68502 | United States |
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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| Placebo |
| Drug |
Matching placebo will be administered orally. |
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Number of participants with Abnormalities in clinical safety laboratory parameters (including hematology, clinical chemistry, and urinalysis) will be reported. |
| Up to Day 7 |
| Cohort 5: Number of Participants with Abnormalities in Clinical Safety Laboratory Parameters | Number of participants with Abnormalities in clinical safety laboratory parameters (including hematology, clinical chemistry, and urinalysis) will be reported. | Up to Day 21 |
| Cohort 1 to 4 and Cohort 6: Number of Participants with Abnormalities in Physical Examinations | Number of participants with abnormalities in physical examinations will be reported. | Up to Day 7 |
| Cohort 5: Number of Participants with Abnormalities in Physical Examinations | Number of participants with abnormalities in physical examinations will be reported. | Up to Day 21 |
Tmax is defined as the time to reach the maximum whole blood concentration of JNJ-88260237. |
| Cohort 1 to 4 and Cohort 6: Up to Day 7; Cohort 5: Up to day 21 |
| Area Under the Whole Blood Concentration Versus Time Curve from Time Zero to Time of the Last Measurable Concentration (AUC [0-Last]) of JNJ-88260237 | AUC (0-Last) is defined as the area under the whole blood concentration versus time curve from time zero to time of the last measurable concentration of JNJ-88260237. | Cohort 1 to 4 and Cohort 6: Up to Day 7; Cohort 5: Up to day 21 |
| Area Under the Whole Blood Concentration Versus Time Curve from Time Zero to Infinite Time (AUC [0-Infinity]) of JNJ-88260237 | AUC (0-infinity) is defined as the area under the whole blood concentration versus time curve from time zero to infinite time of JNJ-88260237. | Cohort 1 to 4 and Cohort 6: Up to Day 7; Cohort 5: Up to day 21 |
| Terminal Half-life (T1/2) of JNJ-88260237 | T1/2 is defined as the terminal half-life of JNJ-88260237. | Cohort 1 to 4 and Cohort 6: Up to Day 7; Cohort 5: Up to day 21 |
| Apparent Oral Whole Blood Clearance (CL/F) of JNJ-88260237 | CL/F is defined as apparent oral whole blood clearance of JNJ-88260237. | Cohort 1 to 4 and Cohort 6: Up to Day 7; Cohort 5: Up to day 21 |
| Apparent Volume of Distribution (Vz/F) of JNJ-88260237 | Vz/F is defined as the apparent volume of distribution of JNJ-88260237. | Cohort 1 to 4 and Cohort 6: Up to Day 7; Cohort 5: Up to day 21 |