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Assisted ReproductionPhase 1NCT06408948

A Study to Evaluate the Mass Balance of [14C]SHR7280 in Healthy Adult Volunteers

A Phase 1 study testing [14C]SHR7280 in people with Assisted Reproduction, 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

Evaluate the Mass Balance of [14C]SHR7280 in Healthy Adult Volunteers. Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Assisted Reproduction
What is being tested?
[14C]SHR7280
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
7 Jun 2024to 6 Jul 2024
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
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Sign the informed consent form prior to the trial and have a full understanding of the trial's procedures, content, and potential adverse reactions;
  • Healthy adult females and males between 18 and 45 years;
  • Body weight ≥50 kg(for male), body weight ≥45 kg(for female), and the body mass index (BMI) of 19 to 26 kg/m2;
  • From the signing of the informed consent form until 12 months after the last administration, the subject (including partner) has no family planning and is willing to use the high-efficiency contraceptive measures specified in the plan;
  • The first three menstrual cycles for women were regular, with a menstrual cycle of 21-35 days, and no abnormal uterine bleeding occurred.

Who cannot join

  • Comprehensive physical examination, vital signs, laboratory tests (blood routine, blood biochemistry, coagulation function, urine analysis, fecal routine+occult blood, thyroid function), full chest X-ray, 12 lead electrocardiogram, abdominal ultrasound, digital rectal examination, bilateral breast, uterus, and bilateral accessory ultrasound results that the researcher deems clinically significant;
  • Serum testosterone (T) <3.46 ng/mL during screening for male; serum follicle stimulating hormone (FSH) ≥ 25mIU/mL during screening period for female;
  • Patients with QTcF>450 msec (male) and QTcF>470 msec (female) at the time of screening or baseline, or other clinically significant abnormalities determined by the researcher;
  • Hepatitis B surface antigen (HBsAg) positive, or anti hepatitis C virus (HCV) antibody positive, or human immunodeficiency virus (HIV) antigen/antibody combined test positive, or Treponema pallidum antibody positive;
  • Screening period or baseline period (D-1) serum pregnancy testing (serum β- The HCG test )result is positive for female;
  • Women use the following contraceptive methods during screening visits: sustained-release intrauterine devices, sustained-release contraceptives (subcutaneous implants, vaginal rings, microspheres, and microcapsules); Before screening, use long-acting contraceptive pills (using medroxyprogesterone acetate for 3 months and other injections for 1 month), oral contraceptives (such as short acting, long-acting, or emergency contraceptives) for 2 months before screening, and contraceptive patches for 1 month before screening; Special circumstances to be determined by the researcher;
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  • Abuse of drugs or use of soft drugs (such as marijuana) in the three months prior to screening, or use of hard drugs (such as amphetamines, phencyclidine, etc.) in the year prior to screening; Or screening period urine drug test positive individuals, including: morphine, methamphetamine (methamphetamine), ketamine, ecstasy (methamphetamine), marijuana (tetrahydrocannabidiol acid);
  • Using any prescription, over-the-counter, herbal or dietary supplements before the first two screening weeks;
  • Women with a history of pregnancy, miscarriage, childbirth, or breastfeeding in the 6 months prior to screening;
  • Any clinical history of serious diseases or conditions that the researcher believes may affect the trial results, including but not limited to a history of circulatory, endocrine, nervous, digestive, urinary, or blood, immune, mental, and metabolic diseases;
  • Individuals with a history of malignant tumors or suspected to have sex hormone dependent malignant tumors;
  • Allergic constitution, or suspected allergy to any ingredient in SHR7280 formulation;
  • Individuals who have undergone any surgery in the first 3 months prior to screening, have not yet recovered after surgery, or are expected to have surgery or hospitalization plans during the trial period;
  • Perianal diseases with hemorrhoids or periodic/ongoing rectal bleeding; The subject is unable to swallow, or has a history of gastrointestinal dysfunction such as irritable bowel syndrome, inflammatory bowel disease, or has undergone surgery such as gastrectomy, which the researcher determines may affect drug absorption;
  • Habitual constipation or diarrhea;
  • Have a history of severe vomiting;
  • Individuals with a history of smoking in the first three months prior to screening (average daily smoking>5 cigarettes);
  • In the three months before screening, the average daily intake of alcohol exceeded 25 g (for example, 750 mL of beer, 250 mL of wine, or 50 mL of Baijiu); Or those with an alcohol breath test result of ≥ 20 mg/dl during the screening period;
  • Habitually drinking grapefruit juice or excessive amounts of tea, coffee, and/or caffeinated beverages, or unable to quit during the trial period;
  • Select clinical trial participants who have participated in any other drug or medical device within the first 3 months or within 5 half-lives of the drug (depending on whether the drug is administered or the device is used);
  • Those who receive the vaccine within 2 weeks before the first administration or within 1 month after the last administration during the study period;
  • Individuals who have donated (or lost) blood and have donated (or lost) more than 400 mL of blood, or have received blood transfusions in the first 3 months prior to screening;
  • Engaged in workers who require long-term exposure to radioactive conditions; Or select individuals who have been significantly exposed to radiation (chest/abdominal CT ≥ 2 times, or other types of X-ray examinations ≥ 3 times) or have participated in radiopharmaceutical labeling trials in the one year prior to screening;
  • Difficulty swallowing, difficulty in venous blood collection, or physical condition unable to withstand blood collection; Or subjects who are expected to be unable to complete the entire trial follow-up;
  • According to the researcher's judgment, the subjects may have factors that affect drug absorption, distribution, metabolism, and excretion, or may reduce compliance, or other factors that are not suitable for participation in this study.

Trial locations and contacts

1 site in 1 country.

China1 site

  • The First Affiliated Hospital of Suzhou University

    Suzhou, Jiangsu, 215008

Other trials in China

About this study

Official title: Phase I Clinical Trial of Mass Balance of [14C]SHR7280 in Healthy Chinese Subjects

Evaluate the Mass Balance of [14C]SHR7280 in Healthy Adult Volunteers.

Being tested
[14C]SHR7280

What participants receive

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

  • [14C]SHR7280Drug

    Patients will receive single dose of orally [14C]SHR7280 on Day 1.

Study groups in NCT06408948
Study groupRoleWhat they receive
[14C]SHR7280ExperimentalNot described
Receives: Drug: [14C]SHR7280

What is being measured

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

  1. Cumulative recovery and recovery rate of total radioactive substance in urine and feces

    Measured: 0-240 hours

  2. Percentage of parent drug and its metabolites in plasma as a percentage of total radioactive exposure (%AUC)

    Measured: 0-120 hours

  3. Percentage of parent drug and its metabolites in urine and feces as a percentage of administered dose (%Dose)

    Measured: 0-240 hours

  4. Radioactivity Tmax

    Measured: 0-120 hours

  5. Radioactivity Cmax

    Measured: 0-120 hours

  6. Radioactivity AUC

    Measured: 0-120 hours

  7. Radioactivity t1/2

    Measured: 0-120 hours

  8. Radioactivity CL/F

    Measured: 0-120 hours

  9. Radioactivity Vz/F

    Measured: 0-120 hours

  10. Total radioactivity ratio for blood/plasma

    Measured: 0-48 hours

Secondary outcomes (8)

  1. Plasma SHR7280: Tmax

    Measured: 0-120 hours

  2. Plasma SHR7280: Cmax

    Measured: 0-120 hours

  3. Plasma SHR7280: AUC

    Measured: 0-120 hours

  4. Plasma SHR7280: t1/2

    Measured: 0-120 hours

  5. Plasma SHR7280: CL/F

    Measured: 0-120 hours

  6. Plasma SHR7280: Vz/F

    Measured: 0-120 hours

  7. Plasma SHR7280: λz

    Measured: 0-120 hours

  8. AEs and SAEs

    Measured: Screening to 10 days

Timeline

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

  1. First posted10 May 2024
  2. Study start7 Jun 2024
  3. Primary completion6 Jul 2024
  4. Study completion6 Jul 2024

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 oral dose of \[14C\]SHR7280
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06408948
Sponsor's protocol ID
SHR7280-106
Status last verified
Jul 2024
First submitted
7 May 2024
Last updated
22 Jul 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing [14C]SHR7280 in people with Assisted Reproduction, 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 5 inclusion and 25 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 22 Jul 2024. 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?

Cumulative recovery and recovery rate of total radioactive substance in urine and feces (time frame: 0-240 hours). The study lists 10 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 NCT06408948.

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 22 Jul 2024.

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