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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04627116
Recruitment Status : Enrolling by invitation
First Posted : November 13, 2020
Last Update Posted : November 13, 2020
Sponsor:
Information provided by (Responsible Party):
Lee's Pharmaceutical Limited

Tracking Information
First Submitted Date  ICMJE September 8, 2020
First Posted Date  ICMJE November 13, 2020
Last Update Posted Date November 13, 2020
Actual Study Start Date  ICMJE April 19, 2020
Estimated Primary Completion Date December 5, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An Ascending, Multiple-Dose, Safety and Tolerability Study of Tecarfarin in Healthy Chinese Volunteers
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Healthy Chinese Volunteers
Intervention  ICMJE Drug: Tecarfarin
Ten (10) healthy Chinese subjects received once-daily doses of Tecarfarin on fasting every morning for 14 days.
Study Arms  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Actual Enrollment  ICMJE
 (submitted: November 8, 2020)
40
Original Actual Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 30, 2020
Estimated Primary Completion Date December 5, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04627116
Other Study ID Numbers  ICMJE 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  ICMJE
Plan to Share IPD: Undecided
Current Responsible Party Lee's Pharmaceutical Limited
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Lee's Pharmaceutical Limited
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Lee's Pharmaceutical Limited
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP