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Healthy Male AdultPhase 1NCT04143750

The Mass Balance and Biotransformation of [14C] Vicagrel in Healthy Man

A Phase 1 study testing [14C]Vicagrel in people with Healthy Male Adult, run by Jiangsu vcare pharmaceutical technology co., LTD at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study was designed to evaluate the mass balance and biotransformation after single-dose of [14C]Vicagrel orally in Chinese healthy male volunteers, revealing the overall pharmacokinetic characteristics of vicagrel in humans, and providing a reference for the rational administration. Read more about this study

Who is it for?
Ages 18 to 45 years, men onlyHealthy volunteers can take part
Conditions the study is for
Healthy Male Adult
What is being tested?
[14C]Vicagrel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
1 siteChina
Study dates
11 Nov 2019to 14 Jan 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 18 to 45 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • A healthy male adult.
  • Age is between 18 and 45, inclusive.
  • Body mass index is between 19 and 26, inclusive.
  • Voluntarily to provide informed consent form.
  • Willing and able to communicate with investigators and complete the trial according to clinical trial protocol.

Who cannot join

  • Any abnormal and clinical significant findings to physic exam, vital sign, electrocardiogram, X-ray exam for chest, laboratory exam including blood biochemical, blood routine, blood coagulation, urine routine, routine stool plus occult blood and thyroid stimulating hormone, and so on.
  • A positive examination result of HBsAg/HBeAg, HIV antibody and treponema pallidum antibody.
  • Volunteers who take any medicines including OTC, hormone birth control and/or alternative medicines such as medicated diets, Chinese herbal medicines, hemostatics or supplements within 14 days before the screening.
  • Volunteers have clinical product administration or clinical trial participation within 3 months before the screening.
  • Any history of clinical serious disease, or presence illness/condition that, in the opinion of the investigator, would jeopardize the study results, including but not limited to the circulatory system, endocrine system, nervous system, digestive system, urinary system or history of blood, immune, mental and metabolic diseases.
  • History of organic heart disease, heart failure, myocardial infarction, angina pectoris, unexplained arrhythmia, torsade ventricular tachycardia, ventricular tachycardia, QT prolongation syndrome, or QT prolongation Symptoms and family history ,indicated by genetic evidence or sudden death of a close relative due to cardiac conditions at a young age.
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  • Volunteers or their immediate family have coagulopathy, coagulative/hemorrhagic disease ,such as hemophilia, gastrointestinal bleeding, cyanosis, coagulative /hemorrhagic symptoms ,such as hematemesis, melena, severe or recurrent epistaxis, hemoptysis, obvious hematuria or intracranial hemorrhage, coagulative/hemorrhagic family history, suspected vascular malformations, such as aneurysm or early onset stroke, CVA < 65 years old, bleeding tendency ,such as repeated bleeding gums, or previous active pathological bleeding.
  • Current or recent (<6 months) disease of dyspepsia, esophageal reflux, stomach bleeding, peptic ulcer, often heartburn over one times every week or any surgery that may affect drug absorption , such as cholecystectomy.
  • Major surgery or surgical incision did not completely heal within 6 months before the screening. Major surgery includes, but is not limited to, any volunteer with significant bleeding risk, prolonged general anesthesia, incision of a biopsy or significant traumatic injury.
  • Ecchymoses were detected in the skin during physical examination.
  • The prothrombin time (PT) and/or activated partial thromboplastin time (APTT) exceeds the upper limit of the normal range, or the hematocrit (HCT) or platelet count (PLT) is out of the normal range.
  • Volunteers who are allergic to drugs, the same type of investigational product ,such as clopidogrel, ticagrelor, etc., pharmaceutical excipients, alcohol, food ingredients. Or who has special requirements for diet and cannot comply with the required diet.
  • Suffering acne or perianal disease in blood in the stool or regularly.
  • Volunteers have habitual constipation, diarrhea, irritable bowel syndrome or inflammatory bowel disease.
  • Volunteers are alcoholism, often drinking in six months before screening which means more than 14 units of alcohol every week, or the alcohol breath test result is positive in screening. One unit alcohol equals 360 mL of beer, 45 mL of 40% alcohol or 150 mL of wine.
  • Volunteers have daily smoking exceeds 5 cigarettes in three months before screening, or habitual use of nicotine products, and can not be withdrawn during the trial.
  • Abusing drug, using soft drugs such as marijuana three months prior to screening, using hard drugs such as cocaine, amphetamine, phencyclidine, etc. one year prior to screening; or urine test for drugs is positive in screeing.
  • Volunteers have habitual drinking of grapefruit juice, excessive tea, coffee and/or caffeinated beverages, and who can not be abstained during the trial.
  • Volunteers who have to work in radioactive conditions in long time, participated in radio-labeled drug clinical trial or had significant radioactive exposure within one year before the trial, more than 2 times of chest/abdominal CT, or more than 3 times of different types of X-ray exam.
  • Volunteer and their spouse who have a birth plan or who are unwilling to take strict contraceptive measures such as condoms, contraceptive sponges, contraceptive gels, contraceptive film, intrauterine device, contraceptive for oral and injection, subcutaneous implant, etc., during the trial or in the future one year after the trial.
  • Volunteers, who have had blood loss/donation up to 400 mL within 3 months before the screening, or received blood transfusion within 1 month.
  • Volunteers are not suitable for this clinical trial, in the opinions of investigators.

Trial locations and contacts

1 site in 1 country.

China1 site

  • The First Affiliated Hospital of Suzhou University

    Suzhou, Jiangsu

Other trials in China

About this study

Official title: The Mass Balance and Biotransformation Study of [14C] Vicagrel in Chinese Healthy Adult Male Volunteers

This study was designed to evaluate the mass balance and biotransformation after single-dose of [14C]Vicagrel orally in Chinese healthy male volunteers, revealing the overall pharmacokinetic characteristics of vicagrel in humans, and providing a reference for the rational administration.

Being tested
[14C]Vicagrel

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • [14C]VicagrelDrug

    Take a suspension of 20 mg vicagrel ,containing about 120 μCi [14C]Vicagrel, in fasting within 5 minutes

Study groups in NCT04143750
Study groupRoleWhat they receive
[14C]VicagrelExperimentalNot described
Receives: Drug: [14C]Vicagrel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Total radioactive datas in blood

    Total radioactive distribution and pharmacokinetics in blood and plasma

    Measured: from 0 hour to 240 hours after administration

  2. Total radioactive datas in excreta

    Total radioactive distribution and pharmacokinetics in urine and feces; the main routes of [14C]Vicagrel excretion in human

    Measured: from 0 hour to 240 hours after administration

  3. Peak Plasma Concentration (Cmax)

    Determine the Cmax of Vicagrel metabolites M3, M9-2, M15-1 and M15-2 in plasma

    Measured: from 0 hour to 240 hours after administration

  4. Area under the plasma concentration versus time curve (AUC)

    Determine the AUC of Vicagrel metabolites M3, M9-2, M15-1 and M15-2 in plasma

    Measured: from 0 hour to 240 hours after administration

  5. Time of Peak Plasma Concentration(Tmax)

    Determine the Tmax of Vicagrel metabolites M3, M9-2, M15-1 and M15-2 in plasma

    Measured: from 0 hour to 240 hours after administration

  6. Drug half-life in plasma(t1/2)

    Determine the T1/2 of Vicagrel metabolites M3, M9-2, M15-1 and M15-2 in plasma

    Measured: from 0 hour to 240 hours after administration

  7. Mean Residence Time (MRT)

    Determine the MRT of Vicagrel metabolites M3, M9-2, M15-1 and M15-2 in plasma

    Measured: from 0 hour to 240 hours after administration

  8. Numbers of Vicagrel Metabolites

    Detect Vicagrel Metabolites in blood, feces and urines as much as possible to clear the main routes of biotransformation

    Measured: from 0 hour to 240 hours after administration

Secondary outcomes (1)

  1. Adverse Events

    Review the relationship between investigational products and all the abnormal and clinically significant findings

    Measured: through the completion of study, an average of 2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Oct 2019
  2. Study start11 Nov 2019
  3. Primary completion29 Dec 2019
  4. Study completion14 Jan 2020

Resources

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
Other
Allocation
Not applicable
Intervention model
Single group
Model description
single arm with single dose of 20mg vicagrel, containing about 120μCi \[14C\]Vicagrel
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04143750
Sponsor's protocol ID
2018-MB-WKGL-08
Status last verified
Apr 2020
First submitted
21 Oct 2019
Last updated
3 Apr 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing [14C]Vicagrel in people with Healthy Male Adult, run by Jiangsu vcare pharmaceutical technology co., LTD 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 5 inclusion and 22 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 3 Apr 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?

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?

Total radioactive datas in blood (time frame: from 0 hour to 240 hours after administration). The study lists 8 primary outcomes in all. 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 NCT04143750.

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 3 Apr 2020.

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