An Ascending, Multiple-Dose, Safety and Tolerability Study of Tecarfarin in Healthy Chinese Volunteers
NCT ID: NCT04627116
Last Updated: 2020-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
40 participants
INTERVENTIONAL
2020-04-19
2020-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
BASIC_SCIENCE
NONE
Study Groups
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Tecarfarin 10mg
Tecarfarin
Ten (10) healthy Chinese subjects received once-daily doses of Tecarfarin on fasting every morning for 14 days.
Tecarfarin 20mg
Tecarfarin
Ten (10) healthy Chinese subjects received once-daily doses of Tecarfarin on fasting every morning for 14 days.
Tecarfarin 30mg
Tecarfarin
Ten (10) healthy Chinese subjects received once-daily doses of Tecarfarin on fasting every morning for 14 days.
Tecarfarin 40mg
Tecarfarin
Ten (10) healthy Chinese subjects received once-daily doses of Tecarfarin on fasting every morning for 14 days.
Interventions
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Tecarfarin
Ten (10) healthy Chinese subjects received once-daily doses of Tecarfarin on fasting every morning for 14 days.
Eligibility Criteria
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Inclusion Criteria
2）Healthy volunteers between the ages of 18 to 50 years old (inclusive). 3）Weight: male ≥ 50.0kg, female ≥ 45.0kg; Body Mass Index (BMI) ≥19 and ≤ 24 kg/m2.
4\) The physical examination, vital sign measurements, clinical laboratory assessments hematology, clinical chemistry, or urinalysis, etc.) and 12-lead ECG were judged normal, or abnormal without clinical significance by the investigators.
Exclusion Criteria
2\) Dysphagia or documented history of any gastrointestinal disorders that affect drug absorption.
3\) Subjects with difficulty in venipuncture, those who cannot tolerate venipuncture, and those who have a history of needlesickness and bloodsickness.
4\) Positive tests for urine drugs of abuse at Screening or a history of drug or alcohol abuse/dependence.
5\) Use of tobacco products 3 months before screening. 6）Heavy tea, coffee and / or caffeinated drinks (more than 8 cups, 1 cup = 250 mL) drinker per day within 3 months prior to screening.
7）Subjects who drunk frequently within 6 months prior to screening (intake of more than 14 units of alcohol per week. A unit is 360 mL beer, 45 mL of 40% liquor or 150 mL wine).
8）Any out-of-normal-range PT, aPTT, TT, FIB,INR, protein C, protein S or coagulation factors II, VII, X at screening.
9）History of cardiovascular, renal, pulmonary, nervous system, liver and/or endocrine disease.
10）Documented history of bleeding diathesis, coagulopathy, or inherited disorders of coagulation.
11）Evidence of active bleeding, including but not limited to gastrointestinal bleeding (hematemesis, hematochezia, positive fecal occult blood), urinary tract bleeding, mucosal bleeding (gingival, epistaxis) and unexplained subcutaneous bleeding or ecchymosis.
12）Participation in a previous clinical trial within 3 months prior to Screening.
13）Clinically significant surgical procedure within 4 weeks prior to Screening or planned to undergo surgery during the study period.
14\) Clinically significant blood loss or blood donation \> 550 ml within 3 months prior to Screening.
15）Taking any medication 14 days prior to Screening. 16）Known allergy or hypersensitivity to warfarin or the investigational product.
17）Pregnancy or Lactation. 18）Female subjects cannot avoid menstruation during administration. 19）subjects of childbearing age are not guaranteed to have no fertility plan, sperm donation, egg donation plan and voluntary use of non-drug contraceptive measures (including subcutaneous injection of contraceptive, contraceptive injections, subcutaneous implantation of contraceptives, local contraceptives such as spermicide, etc.) from two weeks before screening to 6 months after the end of the trial.
20）Investigator would make the subject unsuitable for the study or put them at additional risks.
ALL
Yes
Sponsors
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Lee's Pharmaceutical Limited
INDUSTRY
Responsible Party
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Locations
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The Second Hospital of Anhui Medical University
Hefei, , China
Countries
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References
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Zhou Q, Wang Z, Wang H, Chen Z, Li X, Dai X, Zhang Y, Yu X, Zhou R, Hu W. Safety and Tolerability of Tecarfarin (ATI-5923) in Healthy Chinese Volunteers: Multiple Oral Dose-Escalation Phase I Trial. Am J Cardiovasc Drugs. 2023 Jan;23(1):101-112. doi: 10.1007/s40256-022-00562-5. Epub 2023 Jan 9.
Other Identifiers
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ZK-TEK-201905
Identifier Type: -
Identifier Source: org_study_id