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Healthy Adult Male VolunteersPhase 1NCT04616742

Study to Evaluate the Mass Babance and Biotransformation of [14C]SHR6390 in Healthy Adult Male Volunteers

A Phase 1 study testing [14C]SHR6390 in people with Healthy Adult Male Volunteers, run by Jiangsu HengRui Medicine 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

Study to Evaluate the mass balance and biotransformation of single dose [14C]SHR6390 in Chinese healthy adult male volunteers. 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 Adult Male Volunteers
What is being tested?
[14C]SHR6390
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
1 siteChina
Study dates
11 Nov 2020to 1 May 2021
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

  • Signing the informed consent forms;
  • Healthy adult males;
  • Age: 18 Years to 45 Years(Including the boundary value);
  • Weight: Body mass index(BMI) between 19 and 26 kg/m2(Including the boundary value);

Who cannot join

  • Candidates who meet any of the following conditions will not be selected:
  • Laboratory examination:
  • Complete physical examination, laboratory examination (blood routine, blood biochemistry, urine routine, coagulation function, fecal occulted blood, thyroid function (FT3, FT4, TSH), 12-lead electrocardiogram, X-chest X-ray (orthostatic position), abdominal B-ultrasound (liver, bile, pancreas, spleen, kidney) and other abnormal and clinically significant examinations;
  • Ophthalmologic examination (slit lamp, intraocular pressure and fundus photography) with abnormal clinical significance;
  • Hepatitis B surface antigen or E antigen, hepatitis C antibody, HIV antibody and syphilis antibody, any of which are positive.
  • Medical history:
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  • Screening for use of any clinical trial drug within the first 3 months or withdrawal time shorter than the 6 half-life period of the trial drug at enrollment, whichever is the longest of the two;
  • CYP3A4, CYP2C8 and CYP2C9 inducers or inhibitors were taken within 28 days before screening, as shown in Appendix 1.
  • Use of any prescription or over-the-counter drug, any vitamin product, health care drug or Chinese herbal medicine within 14 days prior to screening;
  • Medical history and treatment history:
  • clinical symptoms or diseases of the heart that cannot be well controlled, such as :(1) heart failure of NYHA2 or above; (2) unstable angina pectoris; (3) myocardial infarction within 1 year; (4) supraventral or ventricular arrhythmia with clinical significance that requires treatment or intervention; (5) QTcF>450ms(male) at screening stage; (5) QTcF>450ms.
  • Patients who had undergone major surgery or whose surgical incision was not completely healed within 6 months before the screening period;Major surgery includes, but is not limited to, any surgery with a significant risk of bleeding, prolonged general anesthesia, or an open biopsy or significant traumatic injury;
  • Screening for abdominal fistula, gastrointestinal perforation or abdominal abscess in the first 6 months;
  • Screening for clinically significant bleeding symptoms or definite bleeding tendency, such as gastrointestinal bleeding and bleeding ulcer, in the first 3 months;
  • Hemorrhoids or perianal diseases with regular/bleeding in the stool;Patients with gastrointestinal dysfunction, such as irritable bowel syndrome and inflammatory bowel disease, may be affected by drug absorption as determined by researchers;
  • Allergic persons, including those with a history of severe drug allergy or drug allergy, and those with known allergy to SHR6390 or similar drugs and excipients;Allergic to any food ingredients or has special requirements on diet, cannot follow the unified diet;
  • A history of any clinically serious illness or condition, including but not limited to circulatory, endocrine, nervous, digestive, urinary, or blood, immune, mental, and metabolic diseases, that the investigator considers to be likely to affect the results of the study;
  • Living Habits:
  • Habitual constipation or diarrhea;
  • Heavy drinking or regular drinking in the six months preceding the screening period, i.e. drinking more than 14 units of alcohol per week (1 unit =285 mL beer or 25 mL spirits of 40% alcohol or 100 mL wine);Or alcohol breath test results at screening period ≥20 mg/ dL;
  • Those who had smoked more than 5 cigarettes per day on average in the 3 months before the screening period or habitually used nicotine-containing products and were unable to quit during the test period;
  • Substance abuse or use of soft drugs (e.g., marijuana) in the 3 months prior to the screening period or use of hard drugs (e.g., cocaine, amphetamines, phenylcyclohexidine, etc.) in the 1 year prior to the screening period;Or screening for positive urine drug abuse (drug) tests;
  • habitual consumption of grapefruit juice or excessive consumption of tea, coffee and/or caffeinated beverages and failure to abstain during the study period;
  • Other:
  • Those with a history of fainting needle or blood, have difficulty in blood collection or cannot tolerate vein puncture for blood collection;
  • Workers engaged in conditions requiring long-term exposure to radioactivity;Or have significant radiation exposure (≥2 chest/abdomen CT, or ≥3 other types of X-ray examinations) within 1 year before the test or have participated in the radiopharmaceutical labeling test;
  • Having family planning during the trial period and within 12 months after the last use of the drug, or not agreeing that subjects and their spouses should take strict contraceptive measures during the trial period and within 12 months after the last use of the drug (see Appendix 2);
  • Those who have lost blood or donated up to 400 mL within 3 months before the screening period, or those who have received blood transfusion, or those who plan to donate blood within 1 month after the end of this test;
  • As determined by the investigator, the subject has other factors that are not suitable for the study.

Trial locations and contacts

1 site in 1 country.

China1 site

  • First affiliated hospital,Soochow University

    Suzhou, Jiangsu, 215006

Other trials in China

About this study

Official title: A Phase I Mass Balance and Biotransformation Study of [14C]SHR6390 in Chinese Healthy Adult Male Volunteers.

Study to Evaluate the mass balance and biotransformation of single dose [14C]SHR6390 in Chinese healthy adult male volunteers.

Being tested
[14C]SHR6390

What participants receive

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

  • [14C]SHR6390Drug

    Patients will receive single dose of orally [14C]SHR6390 on Day 1.

Study groups in NCT04616742
Study groupRoleWhat they receive
[14C]SHR6390ExperimentalNot described
Receives: Drug: [14C]SHR6390

What is being measured

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

  1. Quantitive analysis of whole radioactivity of excrement of orally administered [14C]SHR6390 in chinese healthy adult male volunteers to obtain the mass balance data and the main excretion pathway in human body by liquid scintillation counter.

    The percentage of radioactive dose of [14C] radiolabelled SHR6390 recovered in urine,faces and in total,up to Day 21(approx)

    Measured: up to Day 21 (approx) from the start of administration.

  2. Quantitive analysisi of the concentrations of SHR6390 in plasma using the validated LC-MS to obtain pharmacokinetic data.

    The concentration of SHR6390 in plasma up to D7

    Measured: up to 7 days (approx) form the start of administration

  3. Identification of the main metabolite and biotransformation pathway of SHR6390 and investigation of metabolite in plasma by LC-HR MS

    Proportion of different metabolites of SHR6390 up to D7

    Measured: up to 7 days (approx) form the start of administration

Secondary outcomes (1)

  1. Number of Participants with Adverse Evevts(AEs) and Serious Adverse Evevts

    Laboratory indicators, 12-led electrocardiogram(ECG),ect

    Measured: up to Day 21 (approx) from the start of administration.

Timeline

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

  1. First posted5 Nov 2020
  2. Study start11 Nov 2020
  3. Primary completion8 Jan 2021
  4. Study completion1 May 2021

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
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04616742
Sponsor's protocol ID
SHR6390-I-108
Status last verified
Nov 2020
First submitted
2 Nov 2020
Last updated
12 May 2021
Results posted
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]SHR6390 in people with Healthy Adult Male Volunteers, run by Jiangsu HengRui Medicine 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 4 inclusion and 29 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 12 May 2021. 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?

Quantitive analysis of whole radioactivity of excrement of orally administered [14C]SHR6390 in chinese healthy adult male volunteers to obtain the mass balance data and the main excretion pathway in human body by liquid scintillation counter. (time frame: up to Day 21 (approx) from the start of administration.). The study lists 3 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 NCT04616742.

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 12 May 2021.

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