- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01475279
A Study to Evaluate the Effect of T89(Dantonic®)on Steady-State Pharmacodynamics of Warfarin
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
Study Overview
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
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Texas
-
San Antonio, Texas, United States, 78209
- Healthcare Discoveries, Llc D/B/A Icon Development Solutions
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Nonsmoking male or female with 18-50 years of age and a body mass index (BMI) from 19.0 to 30.0 kg/m2;
- 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;
- 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;
- 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;
- 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;
- 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;
- A negative fecal occult blood test (FOBT) ;
- Agree to avoid participation in contact sports and/or other activities with significant risk of trauma injury for 7 days after each study day;
- Subject understands and is willing, able and likely to comply with all study procedures and restrictions;
- Subject is able to give voluntary oral and written informed consent, at the discretion of the investigator.
Exclusion Criteria:
- Subjects with an elevated INR (INR> 1.2) at screening visit;
- No gastrointestinal bleeding history within 12 months prior to screening visit;
- No history of endoscopically proven peptic ulcer disease;
- Known hypersensitivity to warfarin;
- Prosthetic heart valves, mitral stenosis, or other conditions such as recent (<3 months) pulmonary embolism requiring anticoagulant therapy;
- History or presence of renal and hepatic insufficiency;
- History of hyperthyroidism;
- History of any bleeding disorder or hypercoagulation state;
- Surgical or medical condition liable to interfere with the absorption, metabolism or excretion of warfarin;
- 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);
- 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;
- History of conditions associated with hemorrhagic risk, surgery or head injury within 6 months prior to screening visit;
- Hematological abnormalities (thrombocytopenia, clinically significant low granulocyte count, anemia, hypofibrinogenaemia, hemophilia, purpura, hemopathy with prolongation of bleeding time);
- Blood loss/donation >400 mL within 12 weeks prior to the screening visit and/or during the run-in and treatment periods;
- 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;
- Pregnancy or lactation;
- 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;
- Those subjects unable, in the opinion of the investigator, to comply fully with the trial requirements;
- 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;
- Subjects with positive urine cotinine, urine drug screen and/or alcohol breath test;
- In the opinion of the investigator, patients with medical history or other factors which may interfere with enrollment or the study.
Study Plan
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
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
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
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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.
Clinical Trials on Healthy
-
Prevent Age Resort "Pervaya Liniya"RecruitingHealthy Aging | Healthy Diet | Healthy LifestyleRussian Federation
-
Maastricht University Medical CenterCompletedHealthy Volunteers | Healthy Subjects | Healthy AdultsNetherlands
-
Yale UniversityNot yet recruitingHealth-related Benefits of Introducing Table Olives Into the Diet of Young Adults: Olives For HealthHealthy Diet | Healthy Lifestyle | Healthy Nutrition | CholesterolUnited States
-
Hasselt UniversityRecruitingHealthy | Healthy AgingBelgium
-
Galera Therapeutics, Inc.Syneos HealthCompleted
-
Galera Therapeutics, Inc.Syneos HealthCompletedHealthy | Healthy VolunteersAustralia
-
University of PennsylvaniaActive, not recruitingHealthy | Healthy AgingUnited States
-
Chalmers University of TechnologyGöteborg UniversityCompletedHealthy | Nutrition, HealthySweden
-
University of ManitobaNot yet recruitingHealthy | Healthy Diet
-
King's College LondonUniversity of ReadingCompletedHealthy | Healthy AgingUnited Kingdom
Clinical Trials on Warfarin; Dantonic
-
Tasly Pharmaceuticals, Inc.Completed
-
Tasly Pharmaceuticals, Inc.WithdrawnCoronavirus Disease 2019 | Novel Coronavirus Pneumonia
-
Tasly Pharmaceuticals, Inc.Tasly Pharmaceutical Group Co., LtdNo longer available
-
University Hospital, BrestCompleted
-
University of PadovaCompleted
-
University Hospital, BrestCompletedRecurrent Venous Thromboembolism | Idiopathic Deep Vein ThrombosisFrance
-
Duke UniversityNational Heart, Lung, and Blood Institute (NHLBI); Duke Clinical Research InstituteTerminatedIdiopathic Pulmonary FibrosisUnited States
-
Azienda Ospedaliera Universitaria PoliclinicoCompletedDeep Vein ThrombosisItaly
-
Federal University of São PauloFundação de Amparo à Pesquisa do Estado de São PauloCompletedAtrial FibrillationBrazil
-
Tasly Pharmaceuticals, Inc.CompletedAngina PectorisUnited States