HealthyPhase 1NCT01475279
A Study to Evaluate the Effect of T89(Dantonic®)on Steady-State Pharmacodynamics of Warfarin
A Phase 1 study testing Warfarin; Dantonic in people with Healthy, run by Tasly Pharmaceuticals, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Warfarin; Dantonic
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2011to Jan 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Healthcare Discoveries, LLC d/b/a ICON Development Solutions
San Antonio, Texas, 78209
About this study
Official 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
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.
Read the 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
- Being tested
- Warfarin; Dantonic
- Keywords
- Warfarin, Dantonic, Pharmacodynamics, Pharmacokinetics, Interaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Warfarin; DantonicDrug
Also called coumadin
Individual warfarin dose during the study; 225mg Dantonic b.i.d for one week
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in INR with T89 (Day 25) compared with that without T89 (Day 18)
The mean INR change with T89 (Day 25) and without T89 (Day 18) will be assessed by standard t test.
Measured: outcome measure will be assessed in two weeks and data will be presented up to eight weeks
Secondary outcomes (1)
The change in PK variables for R-warfarin and S-warfarin on Day 17 compared with those on Day 24
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.
Measured: outcome measure will be assessed in two weeks and data will be presented up to eight weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2011 (estimated)
- Study startJul 2011
- Primary completionNov 2011
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tasly Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01475279
- Sponsor's protocol ID
- T89-04-US
- Status last verified
- Nov 2011
- First submitted
- 14 Nov 2011
- Last updated
- 8 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT01475279
- Acronym / sponsor ID
- T89-04-US
- Conditions
- Healthy
- Keywords
- Warfarin, Dantonic, Pharmacodynamics, Pharmacokinetics, Interaction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Tasly Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2011
- Primary completion
- Nov 2011 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 21 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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;
Key exclusion criteria (21 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Warfarin; DantonicAlso: coumadinIndividual warfarin dose during the study; 225mg Dantonic b.i.d for one week | Drug | – |
Primary outcome
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.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Warfarin; Dantonic in people with Healthy, run by Tasly Pharmaceuticals, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2012.