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The purpose of the study is to evaluate the safety and tolerability of a single dose of tecarfarin in healthy Chinese Volunteers. the Pharmacokinetic and pharmacodynamic profile of tecarfarin will also be evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tecarfarin 10mg | Experimental |
| |
| Tecarfarin 20mg | Experimental |
| |
| Tecarfarin 30mg | Experimental |
| |
| Tecarfarin 40mg | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tecarfarin 10mg | Drug | Tecarfarin 10mg tablets |
| |
| Tecarfarin 20mg |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events Frequency | 15 Days | |
| Adverse Events Severity | 15 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration versus time curve | 336 Hours | |
| Peak Plasma Concentration | 336 Hours | |
| Time which Peak Plasma Concentration is Reached |
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Inclusion Criteria:
Subject must voluntarily sign and date an informed consent form, approved by the Institutional Review Board (IRB), prior to the initiation of any study-specific procedure.
Healthy Chinese* volunteers aged between 18 and 55 years inclusive, at the time of Screening
*Definition of "Chinese": Subject is a Han Chinese who born in China (including Hong Kong) with Han Chinese parents and grandparents who born in China (including Hong Kong).
Body Mass Index (BMI) ≥19 and ≤ 24 kg/m2
Subject has been a non-smoker or has not used tobacco or nicotine-containing products for at least 3 months before Screening and prior to Day 1.
Subjects are in general good health with no history of significant diseases and no clinically significant abnormal findings based upon the results of physical examination, 12-lead ECG, laboratory safety tests and vital signs at screening and prior to dosing.
• Vital signs (measured in a sitting position for at least 5 minutes) include tympanic temperature [T], pulse rate [PR], respiratory rate [RR], and blood pressure [BP]).
Female subjects must be non-pregnant, non-lactating or either postmenopausal for at least 2 years or surgically sterile (e.g., hysterectomy, bilateral oophorectomy, bilateral tubal occlusion or ligation) for at least 6 months. For female subjects of child bearing potential, they need to consentient to use appropriate contraceptive methods (abstinence, intrauterine device, diaphragm with spermicide, use by partner of a condom with spermicide) at least 28 days prior to and after dosing. Use of oral contraceptive and implantation of contraceptive methods by female subjects are not acceptable.
Male subjects who have female partners of reproductive potential must either:
Able and willing to follow instructions and to comply with protocol requirements.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jo Jo SH Hai, MBBS | Queen Mary Hospital, Hong Kong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HKU Phase 1 Clinical Trial Centre, The University of Hong Kong | Hong Kong | 000000 | Hong Kong |
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| ID | Term |
|---|---|
| C547288 | tecarfarin |
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| Drug |
two tecarfarin 10mg tablets |
|
| Tecarfarin 30mg | Drug | three tecarfarin 10mg tablets |
|
| Tecarfarin 40mg | Drug | four tecarfarin 10mg tablets |
|
| 336 Hours |
| Elimination Rate Constant | 336 Hours |
| Elimination Half Life | 336 Hours |
| Clearance | 336 Hours |
| Volume of Distribution | 336 Hours |
| International Normalized Ratios | 0 hour, 1 hour, 4 hours, 8 hours,12 hours, day 2, day 3, day 4, day 8, day 15 |
| Prothrombin Time | 0 hour, 1 hour, 4 hours, 8 hours,12 hours, day 2, day 3, day 4, day 8, day 15 |
| Activated Partial Thromboplastin Time | 0 hour, 1 hour, 4 hours, 8 hours,12 hours, day 2, day 3, day 4, day 8, day 15 |
| Coagulation Factor II | 0 hour, 1 hour, 4 hours, 8 hours,12 hours, day 2, day 3, day 4, day 8, day 15 | 8 Days |
| Coagulation Factor VII | 0 hour, 1 hour, 4 hours, 8 hours,12 hours, day 2, day 3, day 4, day 8, day 15 | 8 Days |
| Coagulation Factor X | 0 hour, 1 hour, 4 hours, 8 hours,12 hours, day 2, day 3, day 4, day 8, day 15 | 8 Days |