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

November 7, 2012 updated by: Tasly Pharmaceuticals, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Texas
      • San Antonio, Texas, United States, 78209
        • Healthcare Discoveries, Llc D/B/A Icon Development Solutions

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
The mean INR change with T89 (Day 25) and without T89 (Day 18) will be assessed by standard t test.
outcome measure will be assessed in two weeks and data will be presented up to eight weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
The S- and R-warfarin concentration time profiles will be listed and displayed graphically. And 90% CI of the geometric mean ratio for Cmax and AUClast of both R- and S-warfarin will be caculated.
outcome measure will be assessed in two weeks and data will be presented up to eight weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (Actual)

November 1, 2011

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

November 14, 2011

First Submitted That Met QC Criteria

November 18, 2011

First Posted (Estimate)

November 21, 2011

Study Record Updates

Last Update Posted (Estimate)

November 8, 2012

Last Update Submitted That Met QC Criteria

November 7, 2012

Last Verified

November 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • T89-04-US

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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