A Study to Evaluate the Effect of T89(Dantonic®)on Steady-State Pharmacodynamics of Warfarin

• Register: ClinicalTrials.gov
• Last refreshed on: 12 November 2012
• Main ID: NCT01475279
• Date of registration: 14/11/2011
• Primary sponsor: Tasly Pharmaceuticals, Inc.
• Public title: A Study to Evaluate the Effect of T89(Dantonic®)on Steady-State Pharmacodynamics of Warfarin
• Scientific title: An Open-Label, Multiple-Dose, Single-Center, Sequential, Inpatient Study to Determine the Effect of T89 on Steady-State Pharmacodynamics of Warfarin in Healthy Subjects
• Date of first enrolment: July 2011
• Target sample size: 24
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01475279
• Study type: Interventional
• Study design: Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Countries of recruitment

United States

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Nonsmoking male or female with 18-50 years of age and a body mass index (BMI) from
19.0 to 30.0 kg/m2;

2. Healthy adult with no active medical problems or significant chronic diseases as
determined by the study doctor based on medical history, physical examination and
laboratory evaluations;

3. Taking no medications 2 weeks before Day 0 and during the study, including drugs of
abuse, prescription and non prescription medications (including natural health
products, Vitamins, and herbals) and did not receive vaccinations;

4. Agree to avoid eating Seville oranges, grapefruits (including grapefruit juice),
broccoli, brussels sprouts, charcoal-grilled meats, alcoholic beverages, and
caffeine- and theobromine-containing beverages and foods from the time of screening
visit and the duration of the study;

5. Agree to maintain adequate birth control, independent from hormonal contraceptive
use, from the time of the screening visit and during the study, at the discretion of
the investigator;

6. Agree to abstain from alcoholic beverages, caffeinated beverages and orange juice
from 6pm the night before a study day until completion of that study day;

7. A negative fecal occult blood test (FOBT) ;

8. Agree to avoid participation in contact sports and/or other activities with
significant risk of trauma injury for 7 days after each study day;

9. Subject understands and is willing, able and likely to comply with all study
procedures and restrictions;

10. Subject is able to give voluntary oral and written informed consent, at the
discretion of the investigator.

Exclusion Criteria:

1. Subjects with an elevated INR (INR> 1.2) at screening visit;

2. No gastrointestinal bleeding history within 12 months prior to screening visit;

3. No history of endoscopically proven peptic ulcer disease;

4. Known hypersensitivity to warfarin;

5. Prosthetic heart valves, mitral stenosis, or other conditions such as recent (<3
months) pulmonary embolism requiring anticoagulant therapy;

6. History or presence of renal and hepatic insufficiency;

7. History of hyperthyroidism;

8. History of any bleeding disorder or hypercoagulation state;

9. Surgical or medical condition liable to interfere with the absorption, metabolism or
excretion of warfarin;

10. Regular intake of other medication affecting the process of coagulation or platelet
aggregation (during the 2 weeks prior to screening and/or during the run-in and
treatment periods);

11. Significant change in diet likely to interfere with the effects of warfarin in the 2
weeks prior to screening and/or during the run-in and treatment periods, at the
discretion of the investigator;

12. History of conditions associated with hemorrhagic risk, surgery or head injury within
6 months prior to screening visit;

13. Hematological abnormalities (thrombocytopenia, clinically significant low granulocyte
count, anemia, hypofibrinogenaemia, hemophilia, purpura, hemopathy with prolongation
of bleeding time);

14. Blood loss/donation >400 mL within 12 weeks prior to the screening visit and/or
during the run-in and treatment periods;

15. Known to have serum hepatitis or who are carrier of the hepatitis B surface antigen
(HBsAg), or hepatitis C antibody, or have a positive result to the test for HIV
antigens and/or antibodies;

16. Pregnancy or lactation;

17. Participation in any other clinical trial or receipt of an investigational drug
within 60 days prior to the time of the screening visit, or previous participation in
this study;

18. Those subjects unable, in the opinion of the investigator, to comply fully with the
trial requirements;

19. Subjects with a recent history (within 24 months prior to the screening visit) of
alcoholism or known drug dependence, at the discretion of the investigator;

20. Subjects with positive urine cotinine, urine drug screen and/or alcohol breath test;

21. In the opinion of the investigator, patients with medical history or other factors
which may interfere with enrollment or the study.



Age minimum: 18 Years
Age maximum: 50 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Healthy

Intervention(s)

Drug: Warfarin; Dantonic

Primary Outcome(s)

The change in INR with T89 (Day 25) compared with that without T89 (Day 18) [Time Frame: outcome measure will be assessed in two weeks and data will be presented up to eight weeks]

Secondary Outcome(s)

The change in PK variables for R-warfarin and S-warfarin on Day 17 compared with those on Day 24 [Time Frame: outcome measure will be assessed in two weeks and data will be presented up to eight weeks]

Secondary ID(s)

T89-04-US

Source(s) of Monetary Support

Please refer to primary and secondary sponsors