Pharmacokinetic and Pharmacodynamic Profile of TecarfarinPhase 1NCT03652779
A Study to Evaluate the Safety and Tolerability of Tecarfarin in Healthy Chinese Volunteers
A Phase 1 study testing Tecarfarin 10mg, Tecarfarin 20mg and Tecarfarin 30mg in people with Pharmacokinetic and Pharmacodynamic Profile of Tecarfarin, run by Lee's Pharmaceutical Limited at 1 site in Hong Kong.
Trial summary
The purpose of the study is to evaluate the safety and tolerability of a single dose of tecarfarin in healthy Chinese Volunteers. the Pharmacokinetic and pharmacodynamic profile of tecarfarin will also be evaluated. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetic and Pharmacodynamic Profile of Tecarfarin
- What is being tested?
- Tecarfarin 10mg, Tecarfarin 20mg and Tecarfarin 30mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteHong Kong
- Study dates
- 22 Jun 2018to 28 Oct 2019
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject must voluntarily sign and date an informed consent form, approved by the Institutional Review Board (IRB), prior to the initiation of any study-specific procedure.
- Healthy Chinese* volunteers aged between 18 and 55 years inclusive, at the time of Screening
- Definition of "Chinese": Subject is a Han Chinese who born in China (including Hong Kong) with Han Chinese parents and grandparents who born in China (including Hong Kong).
- Body Mass Index (BMI) ≥19 and ≤ 24 kg/m2
- Subject has been a non-smoker or has not used tobacco or nicotine-containing products for at least 3 months before Screening and prior to Day 1.
- Subjects are in general good health with no history of significant diseases and no clinically significant abnormal findings based upon the results of physical examination, 12-lead ECG, laboratory safety tests and vital signs at screening and prior to dosing.
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- Vital signs (measured in a sitting position for at least 5 minutes) include tympanic temperature [T], pulse rate [PR], respiratory rate [RR], and blood pressure [BP]).
- Female subjects must be non-pregnant, non-lactating or either postmenopausal for at least 2 years or surgically sterile (e.g., hysterectomy, bilateral oophorectomy, bilateral tubal occlusion or ligation) for at least 6 months. For female subjects of child bearing potential, they need to consentient to use appropriate contraceptive methods (abstinence, intrauterine device, diaphragm with spermicide, use by partner of a condom with spermicide) at least 28 days prior to and after dosing. Use of oral contraceptive and implantation of contraceptive methods by female subjects are not acceptable.
- Male subjects who have female partners of reproductive potential must either:
- Abstinence from sexual intercourse during Day -1 to Day 28, or
- Use an approved method of contraception (which may include use of a condom with spermicide or use by partner of oral, implantable or injectable contraceptives, intrauterine device, diaphragm with spermicide) during Day -1 to Day 28.
- Refrain from sperm donation during Day -1 to Day 28.
- Able and willing to follow instructions and to comply with protocol requirements.
Who cannot join
- Positive test results for HIV, syphilis antibody, hepatitis B surface antigen (HBsAg), or hepatitis C antibody (HCV Ab) at Screening.
- Positive tests for alcohol breathalyzer or urine drugs of abuse at Screening or Day -1 or a history of drug abuse/dependence.
- Use of tobacco or nicotine products 3 months before screening and prior to Day 1.
- Heavy caffeine drinker (> 5 cups or glasses of caffeinated beverages [e.g., coffee tea, cola, energy drinks] per day) within 3 months prior to screening.
- Heavy alcohol drinker (more than 30 gram alcohol per day within 3 months prior to screening (30 gram alcohol is approximately equivalent to: i.e. 100ml of aperitif, 300ml of wine or 500ml of beer)).
- Any clinically significant above normal range of prothrombin time, activated partial thromboplastin time, or international normalized ratio or below normal range of Protein C or Protein S laboratory result at Screening.
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- Documented history of bleeding diathesis, coagulopathy, or inherited disorders of coagulation.
- Evidence of active bleeding, including but not limited to bleeding ulcer, bleeding gums, urinalysis positive for more than trace blood at Screening and presence of occult blood in the stool at Screening.
- Subjects with a QTcB interval (QT interval corrected for heart rate according to Bazett's formula) > 450 msec at Screening, confirmed by a repeat assessment.
- Conditions predisposing to QT prolongation including pathological Q-wave (defined as Q-wave >40 msec or depth > 0.4-0.5 mV).
- History or presence of cardiac abnormalities or congenital long QT syndrome based on the final investigators' judgment.
- History or presence of malignancy within the past 2 years, with the exception of adequately treated localized skin cancer (basal cell or squamous cell carcinoma) or carcinoma in-situ of the cervix.
- Participation in a previous clinical trial within 3 months prior to Screening.
- Clinically significant surgical procedure within 3 months prior to Screening.
- Clinically significant blood loss or blood donation > 550 ml within 3 months prior to Day 1.
- Any laboratory results from complete blood picture suspicious of ongoing blood loss.
- Taking any prescription medication 14 days prior to Day -1.
- Routine or as needed consumption of medications, herbal, vitamins or hormone supplements 14 days prior to Day -1 or subject is unable to withhold these medications due to underlying clinical conditions, or unwilling to refrain from taking these medications, during the study period (Day -1 to Day 15).
- Known allergy or hypersensitivity to warfarin or the investigational product.
- Any other conditions or clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during Screening that, in the opinion of the Principal Investigator would make the subject unsuitable for the study or put them at additional risks.
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
HKU Phase 1 Clinical Trial Centre, The University of Hong Kong
Hong Kong, 000000
About this study
Official title: An Open-label, Phase 1, Sequential Cohort, Single-Dose Escalation Study to Assess the Safety and Tolerability of Tecarfarin (ATI-5923) in Healthy Chinese Volunteers
The purpose of the study is to evaluate the safety and tolerability of a single dose of tecarfarin in healthy Chinese Volunteers. the Pharmacokinetic and pharmacodynamic profile of tecarfarin will also be evaluated.
- Being tested
- Tecarfarin 10mg, Tecarfarin 20mg, Tecarfarin 30mg, Tecarfarin 40mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tecarfarin 10mgDrug
Tecarfarin 10mg tablets
Tecarfarin 20mgDrug
two tecarfarin 10mg tablets
Tecarfarin 30mgDrug
three tecarfarin 10mg tablets
Tecarfarin 40mgDrug
four tecarfarin 10mg tablets
| Study group | Role | What they receive |
|---|---|---|
| Tecarfarin 10mg | Experimental | Not described Receives: Drug: Tecarfarin 10mg |
| Tecarfarin 20mg | Experimental | Not described Receives: Drug: Tecarfarin 20mg |
| Tecarfarin 30mg | Experimental | Not described Receives: Drug: Tecarfarin 30mg |
| Tecarfarin 40mg | Experimental | Not described Receives: Drug: Tecarfarin 40mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events Frequency
Measured: 15 Days
Adverse Events Severity
Measured: 15 Days
Secondary outcomes (13)
Area under the plasma concentration versus time curve
Measured: 336 Hours
Peak Plasma Concentration
Measured: 336 Hours
Time which Peak Plasma Concentration is Reached
Measured: 336 Hours
Elimination Rate Constant
Measured: 336 Hours
Elimination Half Life
Measured: 336 Hours
Clearance
Measured: 336 Hours
Volume of Distribution
Measured: 336 Hours
International Normalized Ratios
Measured: 0 hour, 1 hour, 4 hours, 8 hours,12 hours, day 2, day 3, day 4, day 8, day 15
Prothrombin Time
Measured: 0 hour, 1 hour, 4 hours, 8 hours,12 hours, day 2, day 3, day 4, day 8, day 15
Activated Partial Thromboplastin Time
Measured: 0 hour, 1 hour, 4 hours, 8 hours,12 hours, day 2, day 3, day 4, day 8, day 15
Coagulation Factor II
0 hour, 1 hour, 4 hours, 8 hours,12 hours, day 2, day 3, day 4, day 8, day 15
Measured: 8 Days
Coagulation Factor VII
0 hour, 1 hour, 4 hours, 8 hours,12 hours, day 2, day 3, day 4, day 8, day 15
Measured: 8 Days
Coagulation Factor X
0 hour, 1 hour, 4 hours, 8 hours,12 hours, day 2, day 3, day 4, day 8, day 15
Measured: 8 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2018
- Study start22 Jun 2018
- Primary completion28 Oct 2019
- Study completion28 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pharmacokinetic and Pharmacodynamic Profile of TecarfarinStudies 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
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lee's Pharmaceutical Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jo Jo SH Hai, MBBS, Principal investigator, Queen Mary Hospital, Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03652779
- Sponsor's protocol ID
- LP-HK-001
- Status last verified
- Sep 2019
- First submitted
- 28 Aug 2018
- Last updated
- 21 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Phase 1, Sequential Cohort, Single-Dose Escalation Study to Assess the Safety and Tolerability of Tecarfarin (ATI-5923) in Healthy Chinese Volunteers
- ClinicalTrials.gov ID
- NCT03652779
- Acronym / sponsor ID
- LP-HK-001
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Lee's Pharmaceutical LimitedIndustry (pharma, biotech, devices)
- Study start
- 22 Jun 2018 (actual)
- Primary completion
- 28 Oct 2019 (actual)
- Study completion
- 28 Oct 2019 (actual)
- First posted
- 29 Aug 2018 (actual)
- 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 the study is to evaluate the safety and tolerability of a single dose of tecarfarin in healthy Chinese Volunteers. the Pharmacokinetic and pharmacodynamic profile of tecarfarin will also be evaluated.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Tecarfarin 10mg | Experimental | Drug: Tecarfarin 10mg |
| Tecarfarin 20mg | Experimental | Drug: Tecarfarin 20mg |
| Tecarfarin 30mg | Experimental | Drug: Tecarfarin 30mg |
| Tecarfarin 40mg | Experimental | Drug: Tecarfarin 40mg |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Subject must voluntarily sign and date an informed consent form, approved by the Institutional Review Board (IRB), prior to the initiation of any study-specific procedure.
- Healthy Chinese* volunteers aged between 18 and 55 years inclusive, at the time of Screening
- Definition of "Chinese": Subject is a Han Chinese who born in China (including Hong Kong) with Han Chinese parents and grandparents who born in China (including Hong Kong).
- Body Mass Index (BMI) ≥19 and ≤ 24 kg/m2
- Subject has been a non-smoker or has not used tobacco or nicotine-containing products for at least 3 months before Screening and prior to Day 1.
Key exclusion criteria (20 listed)
- Positive test results for HIV, syphilis antibody, hepatitis B surface antigen (HBsAg), or hepatitis C antibody (HCV Ab) at Screening.
- Positive tests for alcohol breathalyzer or urine drugs of abuse at Screening or Day -1 or a history of drug abuse/dependence.
- Use of tobacco or nicotine products 3 months before screening and prior to Day 1.
- Heavy caffeine drinker (> 5 cups or glasses of caffeinated beverages [e.g., coffee tea, cola, energy drinks] per day) within 3 months prior to screening.
- Heavy alcohol drinker (more than 30 gram alcohol per day within 3 months prior to screening (30 gram alcohol is approximately equivalent to: i.e. 100ml of aperitif, 300ml of wine or 500ml of beer)).
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 |
|---|---|---|
| Tecarfarin 10mgTecarfarin 10mg tablets | Drug | Tecarfarin 10mg |
| Tecarfarin 20mgtwo tecarfarin 10mg tablets | Drug | Tecarfarin 20mg |
| Tecarfarin 30mgthree tecarfarin 10mg tablets | Drug | Tecarfarin 30mg |
| Tecarfarin 40mgfour tecarfarin 10mg tablets | Drug | Tecarfarin 40mg |
Primary outcome
Adverse Events Frequency
Time frame: 15 Days
Adverse Events Severity
Time frame: 15 Days
13 secondary outcomes
Area under the plasma concentration versus time curve
Time frame: 336 Hours
Peak Plasma Concentration
Time frame: 336 Hours
Time which Peak Plasma Concentration is Reached
Time frame: 336 Hours
Elimination Rate Constant
Time frame: 336 Hours
Elimination Half Life
Time frame: 336 Hours
Clearance
Time frame: 336 Hours
Volume of Distribution
Time frame: 336 Hours
International Normalized Ratios
Time frame: 0 hour, 1 hour, 4 hours, 8 hours,12 hours, day 2, day 3, day 4, day 8, day 15
Prothrombin Time
Time frame: 0 hour, 1 hour, 4 hours, 8 hours,12 hours, day 2, day 3, day 4, day 8, day 15
Activated Partial Thromboplastin Time
Time frame: 0 hour, 1 hour, 4 hours, 8 hours,12 hours, day 2, day 3, day 4, day 8, day 15
Coagulation Factor II
Time frame: 8 Days
Coagulation Factor VII
Time frame: 8 Days
Coagulation Factor X
Time frame: 8 Days
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 21 Nov 2019.
- Individual participant dataSharing planned: No
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.
Jo Jo SH Hai, MBBS principal investigator
Queen Mary Hospital, Hong Kong
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 Tecarfarin 10mg, Tecarfarin 20mg and Tecarfarin 30mg in people with Pharmacokinetic and Pharmacodynamic Profile of Tecarfarin, run by Lee's Pharmaceutical Limited at 1 site in Hong Kong.
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 13 inclusion and 20 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 21 Nov 2019. 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 Hong Kong. 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?
Adverse Events Frequency (time frame: 15 Days). The study lists 2 primary outcomes in all. 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 21 Nov 2019.