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

NCT ID: NCT01475279

Last Updated: 2012-11-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2012-01-31

Brief Summary

The purpose of this study is to evaluate the potential effect of Dantonic on the steady-state pharmacodynamics and pharmacokinetic of warfarin in healthy subjects and safety of the co-administration of Dantonic and warfarin.

Detailed Description

Due to a large proportion of patients that could benefit from Dantonic treatment is likely to take warfarin concomitantly. And there is no systematic experience of warfarin drug-drug interaction between Dantonic and warfarin on humans. It is highly relevant to investigate the potential interaction of theses two drugs.

Primary endpoint:

•The change in INR with T89 (Day 25) compared with that without T89 (Day 18)

Secondary endpoints:

• The change in PK variables for R-warfarin and S-warfarin on Day 17 compared with those on Day 24
• Safety assessments across all time points

Conditions

Healthy

Keywords

Warfarin; Dantonic; Pharmacodynamics; Pharmacokinetics; Interaction

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Interventions

Warfarin; Dantonic

Individual warfarin dose during the study; 225mg Dantonic b.i.d for one week

Intervention Type: DRUG

Other Intervention Names

coumadin

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Tasly Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Healthcare Discoveries, LLC d/b/a ICON Development Solutions

San Antonio, Texas, United States

Countries

United States

Other Identifiers

T89-04-US

Identifier Type: -

Identifier Source: org_study_id