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| ID | Type | Description | Link |
|---|---|---|---|
| 70033093THR1004 | Other Identifier | Janssen Research & Development, LLC |
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The purpose of this study is to characterize the pharmacokinetic (PK) of multiple twice-daily doses of JNJ-70033093 in healthy participants and to assess the effects of dosing time and food on the PK of single-dose of JNJ-70033093 in healthy participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: Treatment A | Experimental | Participants will receive JNJ-70033093 dose twice daily (BID) for 8 days followed by a placebo dose on Day 9 or placebo BID for 8 days followed by a placebo dose on Day 9. |
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| Part 1: Treatment B | Experimental | Participants will receive JNJ-70033093 dose BID for 8 days followed by a placebo dose on Day 9 or placebo BID for 8 days followed by a placebo dose on Day 9. |
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| Part 1: Treatment C | Experimental | Participants will receive JNJ-70033093 dose BID for 8 days followed by a JNJ-70033093 dose on Day 9 or placebo BID for 8 days followed by a placebo dose on Day 9. |
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| Part 1: Treatment D | Experimental | Participants will receive JNJ-70033093 dose BID for 8 days followed by a JNJ-70033093 dose on Day 9 or placebo BID for 8 days followed by a placebo dose on Day 9. |
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| Part 2: Treatment Sequence EFG | Experimental | Participants will receive Treatment E (JNJ-7003309 single dose in the morning in fasted condition) in treatment Period 1; followed by Treatment F (JNJ-7003309 single dose administered in the evening in fasted condition) in treatment Period 2; followed by Treatment G (JNJ-7003309 single dose administered in the evening in fasted condition) in treatment Period 3, on Day 1 of each treatment period. A washout period of at least 4 days will be maintained between each treatment period. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ-70033093 | Drug | JNJ-70033093 capsules will be administered orally . |
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| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Maximum Observed Analyte Concentration (Cmax) of JNJ-70033093 | Cmax is the maximum observed analyte concentration. | Up to Day 9 |
| Part 1: Time to Reach the Maximum Observed Analyte Concentration (Tmax) of JNJ-70033093 | Tmax is the actual sampling time to reach the maximum observed analyte concentration | Up to Day 9 |
| Part 1: Area Under the Analyte Concentration-time Curve from Time Zero to 12 Hours (AUC[0-12h]) of JNJ-70033093 | AUC(0-12h) is the area under the time-concentration curve (AUC) from time 0 (dosing time) to 12 hours before steady state. | 12 hours postdose (Day 1) |
| Part 1: Apparent Terminal Elimination Half-life (t[1/2]) of JNJ-70033093 | T(1/2) is the apparent terminal elimination half-life is the time measured for the analyte concentration to decrease by 1 half to its original concentration. It is associated with the terminal slope of the semi logarithmic drug concentration-time curve, and is calculated as 0.693/lambda(z). | Up to Day 9 |
| Part 2: Maximum Observed Analyte Concentration (Cmax) of JNJ-70033093 | Cmax is the maximum observed analyte concentration. | Up to Day 9 |
| Part 2: Area Under the Concentration-time Curve from Time Zero to the Last Measurable Concentration (AUC [0-last]) of JNJ-70033093 | AUC (0-last) is area under the analyte concentration-time curve (AUC) from time 0 to time of the last quantifiable (non-below quantification limit [non-BQL]) concentration, calculated by linear-linear trapezoidal summation. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability | An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product does not necessarily have a causal relationship with the treatment. | Up to 51 days |
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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 | Salt Lake City | Utah | 84124 | 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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| ID | Term |
|---|---|
| C000720754 | milvexian |
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| Part 2: Treatment Sequence FGE | Experimental | Participants will receive Treatment F in treatment Period 1; followed by Treatment G in treatment Period 2; followed by Treatment E in treatment Period 3, on Day 1 of each treatment period. A washout period of at least 4 days will be maintained between each treatment period. |
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| Part 2: Treatment Sequence GEF | Experimental | Participants will receive Treatment G in treatment Period 1; followed by Treatment E in treatment Period 2; followed by Treatment F in treatment Period 3, on Day 1 of each treatment period. A washout period of at least 4 days will be maintained between each treatment period |
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| Part 2: Treatment Sequence EGF | Experimental | Participants will receive Treatment E in treatment Period 1; followed by Treatment G in treatment Period 2; followed by Treatment F in treatment Period 3, on Day 1 of each treatment period. A washout period of at least 4 days will be maintained between each treatment period |
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| Part 2: Treatment Sequence GFE | Experimental | Participants will receive Treatment G in treatment Period 1; followed by Treatment F in treatment Period 2; followed by Treatment E in treatment Period 3, on Day 1 of each treatment period. A washout period of at least 4 days will be maintained between each treatment period |
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| Part 2: Treatment Sequence FEG | Experimental | Participants will receive Treatment F in treatment Period 1; followed by Treatment E in treatment Period 2; followed by Treatment G in treatment Period 3, on Day 1 of each treatment period. A washout period of at least 4 days will be maintained between each treatment period |
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| Placebo | Drug | Matching placebo in capsule will be administered orally. |
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| Up to Day 9 |
| Part 2: Area Under the Concentration-time Curve from Time Zero to Infinity (AUC [0-infinity]) of JNJ-70033093 | AUC (0-infinity) is the area under the analyte concentration-time curve (AUC) from time zero to infinite time, calculated as the sum of AUC (0-last) and C(last)/lambda(z); wherein AUC (0-last) is area under the plasma concentration-time curve from time zero to last measurable concentration, C(last) is the last observed measurable (non-BQL) analyte concentration; and lambda(z) is apparent terminal elimination rate constant. | Up to Day 9 |
| Number of Participants with Vital Sign Abnormalities |
Number of participants with vital signs (including body temperature, resting [supine] pulse rate, and blood pressure) abnormalities will be reported. |
| Up to 51 days |
| Number of Participants with Abnormal Electrocardiogram (ECG) Findings | Number of participants with abnormal ECG findings will be reported. | Up to 51 days |
| Number of Participants with Abnormal Laboratory Findings | Number of participants with abnormal laboratory findings (that is, hematology, coagulation tests, clinical chemistry, urinalysis) will be reported. | Up to 51 days |
| Relationship Between JNJ-70033093 Plasma Concentrations and QTc After Multiple Doses of JNJ-70033093 | Relationship between JNJ-70033093 plasma concentrations and QTc in healthy participants receiving multiple doses of JNJ-70033093 will be assessed. | Up to Day 9 |
| Percentage Change from Baseline in Activated Partial Thromboplastin Time (aPTT) | aPTT measures the time to clot formation via the contact and common activation pathway. Blood will be collected for measurement of changes in aPTT clotting time. | Baseline up to Day 9 (Part 1); Baseline up to Day 11 (Part 2) |
| Percentage Change from Baseline in Factor XI Clotting Activity | Percentage change from baseline in FXI clotting activity will be measured using a modified aPTT assay. | Baseline up to Day 9 (Part 1); Baseline up to Day 11 (Part 2) |