Healthy Chinese VolunteersPhase 1NCT04627116
An Ascending, Multiple-Dose, Safety and Tolerability Study of Tecarfarin in Healthy Chinese Volunteers
A Phase 1 study testing Tecarfarin in people with Healthy Chinese Volunteers, run by Lee's Pharmaceutical Limited at 1 site in China.
Trial summary
The subjects will be admitted to the Phase I Clinical Research Center on day -1. Subjects received once-daily doses of Tecarfarin for up to 14 days.Subjects can leave the Phase I Clinical Research Center on the day 21.And returned to the research center for follow-up on the day 28 and 35. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Healthy Chinese Volunteers
- What is being tested?
- Tecarfarin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 19 Apr 2020to 30 Dec 2020
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 1) the subjects were fully aware of the purpose, nature, methods and possible adverse reactions of the trial, voluntarily act as subjects, and sign an informed consent form before the commencement of any research process.
- 2）Healthy volunteers between the ages of 18 to 50 years old (inclusive). 3）Weight: male ≥ 50.0kg, female ≥ 45.0kg; Body Mass Index (BMI) ≥19 and ≤ 24 kg/m2.
- 4) The physical examination, vital sign measurements, clinical laboratory assessments hematology, clinical chemistry, or urinalysis, etc.) and 12-lead ECG were judged normal, or abnormal without clinical significance by the investigators.
Who cannot join
- 1. Positive test results for HIV, syphilis antibody, hepatitis B surface antigen (HBsAg), or hepatitis C antibody (HCV Ab) at Screening.
- 2) Dysphagia or documented history of any gastrointestinal disorders that affect drug absorption.
- 3) Subjects with difficulty in venipuncture, those who cannot tolerate venipuncture, and those who have a history of needlesickness and bloodsickness.
- 4) Positive tests for urine drugs of abuse at Screening or a history of drug or alcohol abuse/dependence.
- 5) Use of tobacco products 3 months before screening. 6）Heavy tea, coffee and / or caffeinated drinks (more than 8 cups, 1 cup = 250 mL) drinker per day within 3 months prior to screening.
- 7）Subjects who drunk frequently within 6 months prior to screening (intake of more than 14 units of alcohol per week. A unit is 360 mL beer, 45 mL of 40% liquor or 150 mL wine).
Show all 16Show fewer
- 8）Any out-of-normal-range PT, aPTT, TT, FIB,INR, protein C, protein S or coagulation factors II, VII, X at screening.
- 9）History of cardiovascular, renal, pulmonary, nervous system, liver and/or endocrine disease.
- 10）Documented history of bleeding diathesis, coagulopathy, or inherited disorders of coagulation.
- 11）Evidence of active bleeding, including but not limited to gastrointestinal bleeding (hematemesis, hematochezia, positive fecal occult blood), urinary tract bleeding, mucosal bleeding (gingival, epistaxis) and unexplained subcutaneous bleeding or ecchymosis.
- 12）Participation in a previous clinical trial within 3 months prior to Screening.
- 13）Clinically significant surgical procedure within 4 weeks prior to Screening or planned to undergo surgery during the study period.
- 14) Clinically significant blood loss or blood donation > 550 ml within 3 months prior to Screening.
- 15）Taking any medication 14 days prior to Screening. 16）Known allergy or hypersensitivity to warfarin or the investigational product.
- 17）Pregnancy or Lactation. 18）Female subjects cannot avoid menstruation during administration. 19）subjects of childbearing age are not guaranteed to have no fertility plan, sperm donation, egg donation plan and voluntary use of non-drug contraceptive measures (including subcutaneous injection of contraceptive, contraceptive injections, subcutaneous implantation of contraceptives, local contraceptives such as spermicide, etc.) from two weeks before screening to 6 months after the end of the trial.
- 20）Investigator would make the subject unsuitable for the study or put them at additional risks.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multiple-Dose, Safety and Tolerability、PK/PD Study of Tecarfarin in Healthy Chinese Volunteers
The subjects will be admitted to the Phase I Clinical Research Center on day -1. Subjects received once-daily doses of Tecarfarin for up to 14 days.Subjects can leave the Phase I Clinical Research Center on the day 21.And returned to the research center for follow-up on the day 28 and 35.
- Conditions
- Healthy Chinese Volunteers
- Being tested
- Tecarfarin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TecarfarinDrug
Ten (10) healthy Chinese subjects received once-daily doses of Tecarfarin on fasting every morning for 14 days.
| Study group | Role | What they receive |
|---|---|---|
| Tecarfarin 10mg | Experimental | Not described Receives: Drug: Tecarfarin |
| Tecarfarin 20mg | Experimental | Not described Receives: Drug: Tecarfarin |
| Tecarfarin 30mg | Experimental | Not described Receives: Drug: Tecarfarin |
| Tecarfarin 40mg | Experimental | Not described Receives: Drug: Tecarfarin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective of this study was to evaluate the safety and tolerability of Tecarfarin when administered as rising multiple oral doses to healthy Chinese volunteers.
Subjects received once-daily doses of Tecarfarin for up to 14 days.
Measured: doses of Tecarfarin for up to 14 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2020
- Study start19 Apr 2020
- Primary completion5 Dec 2020 (estimated)
- Study completion30 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy Chinese VolunteersStudies 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04627116
- Sponsor's protocol ID
- ZK-TEK-201905
- Status last verified
- Nov 2020
- First submitted
- 8 Sep 2020
- Last updated
- 13 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Zhou Q, Wang Z, Wang H, Chen Z, Li X, Dai X, Zhang Y, Yu X, Zhou R, Hu W. Safety and Tolerability of Tecarfarin (ATI-5923) in Healthy Chinese Volunteers: Multiple Oral Dose-Escalation Phase I Trial. Am J Cardiovasc Drugs. 2023 Jan;23(1):101-112. doi: 10.1007/s40256-022-00562-5. Epub 2023 Jan 9.
PubMed 36622539
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multiple-Dose, Safety and Tolerability、PK/PD Study of Tecarfarin in Healthy Chinese Volunteers
- ClinicalTrials.gov ID
- NCT04627116
- Acronym / sponsor ID
- ZK-TEK-201905
- Conditions
- Healthy Chinese Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Lee's Pharmaceutical LimitedIndustry (pharma, biotech, devices)
- Study start
- 19 Apr 2020 (actual)
- Primary completion
- 5 Dec 2020 (estimated)
- Study completion
- 30 Dec 2020 (estimated)
- First posted
- 13 Nov 2020 (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 subjects will be admitted to the Phase I Clinical Research Center on day -1. Subjects received once-daily doses of Tecarfarin for up to 14 days.Subjects can leave the Phase I Clinical Research Center on the day 21.And returned to the research center for follow-up on the day 28 and 35.
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 |
| Tecarfarin 20mg | Experimental | Drug: Tecarfarin |
| Tecarfarin 30mg | Experimental | Drug: Tecarfarin |
| Tecarfarin 40mg | Experimental | Drug: Tecarfarin |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 1) the subjects were fully aware of the purpose, nature, methods and possible adverse reactions of the trial, voluntarily act as subjects, and sign an informed consent form before the commencement of any research process.
- 2）Healthy volunteers between the ages of 18 to 50 years old (inclusive). 3）Weight: male ≥ 50.0kg, female ≥ 45.0kg; Body Mass Index (BMI) ≥19 and ≤ 24 kg/m2.
- 4) The physical examination, vital sign measurements, clinical laboratory assessments hematology, clinical chemistry, or urinalysis, etc.) and 12-lead ECG were judged normal, or abnormal without clinical significance by the investigators.
Key exclusion criteria (16 listed)
- 1. Positive test results for HIV, syphilis antibody, hepatitis B surface antigen (HBsAg), or hepatitis C antibody (HCV Ab) at Screening.
- 2) Dysphagia or documented history of any gastrointestinal disorders that affect drug absorption.
- 3) Subjects with difficulty in venipuncture, those who cannot tolerate venipuncture, and those who have a history of needlesickness and bloodsickness.
- 4) Positive tests for urine drugs of abuse at Screening or a history of drug or alcohol abuse/dependence.
- 5) Use of tobacco products 3 months before screening. 6）Heavy tea, coffee and / or caffeinated drinks (more than 8 cups, 1 cup = 250 mL) drinker per day within 3 months prior to screening.
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 |
|---|---|---|
| TecarfarinTen (10) healthy Chinese subjects received once-daily doses of Tecarfarin on fasting every morning for 14 days. | Drug | Tecarfarin 10mg, Tecarfarin 20mg, Tecarfarin 30mg, Tecarfarin 40mg |
Primary outcome
The primary objective of this study was to evaluate the safety and tolerability of Tecarfarin when administered as rising multiple oral doses to healthy Chinese volunteers.
Time frame: doses of Tecarfarin for up to 14 days.
Subjects received once-daily doses of Tecarfarin for up to 14 days.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2020.
- Derived from this study: PubMed 36622539Zhou Q, Wang Z, Wang H, Chen Z, Li X, Dai X, Zhang Y, Yu X, Zhou R, Hu W. Safety and Tolerability of Tecarfarin (ATI-5923) in Healthy Chinese Volunteers: Multiple Oral Dose-Escalation Phase I Trial. Am J Cardiovasc Drugs. 2023 Jan;23(1):101-112. doi: 10.1007/s40256-022-00562-5. Epub 2023 Jan 9.
- Individual participant dataSharing planned: Undecided
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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 Tecarfarin in people with Healthy Chinese Volunteers, run by Lee's Pharmaceutical Limited at 1 site in China.
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 3 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 13 Nov 2020. 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 China. 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?
Results are not available in the source record.
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 primary objective of this study was to evaluate the safety and tolerability of Tecarfarin when administered as rising multiple oral doses to healthy Chinese volunteers. (time frame: doses of Tecarfarin for up to 14 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04627116, which also lists 1 linked publication.
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 13 Nov 2020.