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A Study to Evaluate the Safety and Tolerability 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: NCT03652779
Recruitment Status : Completed
First Posted : August 29, 2018
Last Update Posted : November 21, 2019
Sponsor:
Information provided by (Responsible Party):
Lee's Pharmaceutical Limited

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pharmacokinetic and Pharmacodynamic Profile of Tecarfarin Drug: Tecarfarin 10mg Drug: Tecarfarin 20mg Drug: Tecarfarin 30mg Drug: Tecarfarin 40mg Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: An Open-label, Phase 1, Sequential Cohort, Single-Dose Escalation Study to Assess the Safety and Tolerability of Tecarfarin (ATI-5923) in Healthy Chinese Volunteers
Actual Study Start Date : June 22, 2018
Actual Primary Completion Date : October 28, 2019
Actual Study Completion Date : October 28, 2019

Arm Intervention/treatment
Experimental: Tecarfarin 10mg Drug: Tecarfarin 10mg
Tecarfarin 10mg tablets

Experimental: Tecarfarin 20mg Drug: Tecarfarin 20mg
two tecarfarin 10mg tablets

Experimental: Tecarfarin 30mg Drug: Tecarfarin 30mg
three tecarfarin 10mg tablets

Experimental: Tecarfarin 40mg Drug: Tecarfarin 40mg
four tecarfarin 10mg tablets




Primary Outcome Measures :
  1. Adverse Events Frequency [ Time Frame: 15 Days ]
  2. Adverse Events Severity [ Time Frame: 15 Days ]

Secondary Outcome Measures :
  1. Area under the plasma concentration versus time curve [ Time Frame: 336 Hours ]
  2. Peak Plasma Concentration [ Time Frame: 336 Hours ]
  3. Time which Peak Plasma Concentration is Reached [ Time Frame: 336 Hours ]
  4. Elimination Rate Constant [ Time Frame: 336 Hours ]
  5. Elimination Half Life [ Time Frame: 336 Hours ]
  6. Clearance [ Time Frame: 336 Hours ]
  7. Volume of Distribution [ Time Frame: 336 Hours ]
  8. International Normalized Ratios [ Time Frame: 0 hour, 1 hour, 4 hours, 8 hours,12 hours, day 2, day 3, day 4, day 8, day 15 ]
  9. Prothrombin Time [ Time Frame: 0 hour, 1 hour, 4 hours, 8 hours,12 hours, day 2, day 3, day 4, day 8, day 15 ]
  10. Activated Partial Thromboplastin Time [ Time Frame: 0 hour, 1 hour, 4 hours, 8 hours,12 hours, day 2, day 3, day 4, day 8, day 15 ]
  11. Coagulation Factor II [ Time Frame: 8 Days ]
    0 hour, 1 hour, 4 hours, 8 hours,12 hours, day 2, day 3, day 4, day 8, day 15

  12. Coagulation Factor VII [ Time Frame: 8 Days ]
    0 hour, 1 hour, 4 hours, 8 hours,12 hours, day 2, day 3, day 4, day 8, day 15

  13. Coagulation Factor X [ Time Frame: 8 Days ]
    0 hour, 1 hour, 4 hours, 8 hours,12 hours, day 2, day 3, day 4, day 8, day 15



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. 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.
  2. 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).

  3. Body Mass Index (BMI) ≥19 and ≤ 24 kg/m2
  4. 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.
  5. 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]).

  6. 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.
  7. Male subjects who have female partners of reproductive potential must either:

    • Abstinence from sexual intercourse during Day -1 to Day 28, or
    • Use an approved method of contraception (which may include use of a condom with spermicide or use by partner of oral, implantable or injectable contraceptives, intrauterine device, diaphragm with spermicide) during Day -1 to Day 28.
    • Refrain from sperm donation during Day -1 to Day 28.
  8. Able and willing to follow instructions and to comply with protocol requirements.

Exclusion Criteria:

  1. Positive test results for HIV, syphilis antibody, hepatitis B surface antigen (HBsAg), or hepatitis C antibody (HCV Ab) at Screening.
  2. Positive tests for alcohol breathalyzer or urine drugs of abuse at Screening or Day -1 or a history of drug abuse/dependence.
  3. Use of tobacco or nicotine products 3 months before screening and prior to Day 1.
  4. Heavy caffeine drinker (> 5 cups or glasses of caffeinated beverages [e.g., coffee tea, cola, energy drinks] per day) within 3 months prior to screening.
  5. Heavy alcohol drinker (more than 30 gram alcohol per day within 3 months prior to screening (30 gram alcohol is approximately equivalent to: i.e. 100ml of aperitif, 300ml of wine or 500ml of beer)).
  6. Any clinically significant above normal range of prothrombin time, activated partial thromboplastin time, or international normalized ratio or below normal range of Protein C or Protein S laboratory result at Screening.
  7. Documented history of bleeding diathesis, coagulopathy, or inherited disorders of coagulation.
  8. Evidence of active bleeding, including but not limited to bleeding ulcer, bleeding gums, urinalysis positive for more than trace blood at Screening and presence of occult blood in the stool at Screening.
  9. Subjects with a QTcB interval (QT interval corrected for heart rate according to Bazett's formula) > 450 msec at Screening, confirmed by a repeat assessment.
  10. Conditions predisposing to QT prolongation including pathological Q-wave (defined as Q-wave >40 msec or depth > 0.4-0.5 mV).
  11. History or presence of cardiac abnormalities or congenital long QT syndrome based on the final investigators' judgment.
  12. History or presence of malignancy within the past 2 years, with the exception of adequately treated localized skin cancer (basal cell or squamous cell carcinoma) or carcinoma in-situ of the cervix.
  13. Participation in a previous clinical trial within 3 months prior to Screening.
  14. Clinically significant surgical procedure within 3 months prior to Screening.
  15. Clinically significant blood loss or blood donation > 550 ml within 3 months prior to Day 1.
  16. Any laboratory results from complete blood picture suspicious of ongoing blood loss.
  17. Taking any prescription medication 14 days prior to Day -1.
  18. Routine or as needed consumption of medications, herbal, vitamins or hormone supplements 14 days prior to Day -1 or subject is unable to withhold these medications due to underlying clinical conditions, or unwilling to refrain from taking these medications, during the study period (Day -1 to Day 15).
  19. Known allergy or hypersensitivity to warfarin or the investigational product.
  20. Any other conditions or clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during Screening that, in the opinion of the Principal Investigator would make the subject unsuitable for the study or put them at additional risks.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03652779


Locations
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Hong Kong
HKU Phase 1 Clinical Trial Centre, The University of Hong Kong
Hong Kong, Hong Kong, 000000
Sponsors and Collaborators
Lee's Pharmaceutical Limited
Investigators
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Principal Investigator: Jo Jo SH Hai, MBBS Queen Mary Hospital, Hong Kong

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Responsible Party: Lee's Pharmaceutical Limited
ClinicalTrials.gov Identifier: NCT03652779    
Other Study ID Numbers: LP-HK-001
First Posted: August 29, 2018    Key Record Dates
Last Update Posted: November 21, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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