An Ascending, Multiple-Dose, Safety and Tolerability Study of Tecarfarin in Healthy Chinese Volunteers

• ClinicalTrials.gov Identifier: NCT04627116
• Recruitment Status: Enrolling by invitation
• First Posted: November 13, 2020
• Last Update Posted: November 13, 2020
• Sponsor: Lee's Pharmaceutical Limited
• Information provided by (Responsible Party): Lee's Pharmaceutical Limited

Tracking Information

• First Submitted Date: September 8, 2020
• First Posted Date: November 13, 2020
• Last Update Posted Date: November 13, 2020
• Actual Study Start Date: April 19, 2020
• Estimated Primary Completion Date: December 5, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 8, 2020)

The primary objective of this study was to evaluate the safety and tolerability of Tecarfarin when administered as rising multiple oral doses to healthy Chinese volunteers. [ Time Frame: doses of Tecarfarin for up to 14 days. ]

Subjects received once-daily doses of Tecarfarin for up to 14 days.

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: An Ascending, Multiple-Dose, Safety and Tolerability Study of Tecarfarin in Healthy Chinese Volunteers
• Official Title: A Multiple-Dose, Safety and Tolerability、PK/PD Study of Tecarfarin in Healthy Chinese Volunteers
• Brief Summary: The subjects will be admitted to the Phase I Clinical Research Center on day -1. Subjects received once-daily doses of Tecarfarin for up to 14 days.Subjects can leave the Phase I Clinical Research Center on the day 21.And returned to the research center for follow-up on the day 28 and 35.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Non-Randomized; Intervention Model: Sequential Assignment; Masking: None (Open Label); Primary Purpose: Basic Science
• Condition: Healthy Chinese Volunteers

Intervention

Drug: Tecarfarin

Ten (10) healthy Chinese subjects received once-daily doses of Tecarfarin on fasting every morning for 14 days.

Study Arms

• Experimental: Tecarfarin 10mg
  Intervention: Drug: Tecarfarin
• Experimental: Tecarfarin 20mg
  Intervention: Drug: Tecarfarin
• Experimental: Tecarfarin 30mg
  Intervention: Drug: Tecarfarin
• Experimental: Tecarfarin 40mg
  Intervention: Drug: Tecarfarin

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Enrolling by invitation
• Actual Enrollment (submitted: November 8, 2020): 40
• Original Actual Enrollment: Same as current
• Estimated Study Completion Date: December 30, 2020
• Estimated Primary Completion Date: December 5, 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

1) the subjects were fully aware of the purpose, nature, methods and possible adverse reactions of the trial, voluntarily act as subjects, and sign an informed consent form before the commencement of any research process.

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:

1. Positive test results for HIV, syphilis antibody, hepatitis B surface antigen (HBsAg), or hepatitis C antibody (HCV Ab) at Screening.

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT04627116
• Other Study ID Numbers: ZK-TEK-201905
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: Lee's Pharmaceutical Limited
• Original Responsible Party: Same as current
• Current Study Sponsor: Lee's Pharmaceutical Limited
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Lee's Pharmaceutical Limited
• Verification Date: November 2020