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

NCT06408948 | Completed Phase 1

• 1 other identifier: SHR7280-106
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Assisted Reproduction

Outcome Measures

Primary Outcomes (10)

• Cumulative recovery and recovery rate of total radioactive substance in urine and feces

  0-240 hours

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

  0-120 hours

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

  0-240 hours

• Radioactivity Tmax

  0-120 hours

• Radioactivity Cmax

  0-120 hours

• Radioactivity AUC

  0-120 hours

• Radioactivity t1/2

  0-120 hours

• Radioactivity CL/F

  0-120 hours

• Radioactivity Vz/F

  0-120 hours

• Total radioactivity ratio for blood/plasma

  0-48 hours

Secondary Outcomes (8)

• Plasma SHR7280: Tmax

  0-120 hours

• Plasma SHR7280: Cmax

  0-120 hours

• Plasma SHR7280: AUC

  0-120 hours

• Plasma SHR7280: t1/2

  0-120 hours

• Plasma SHR7280: CL/F

  0-120 hours

Study Arms (1)

[14C]SHR7280

EXPERIMENTAL

Drug: [14C]SHR7280

Interventions

[14C]SHR7280 DRUG

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

[14C]SHR7280

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

The First Affiliated Hospital of Suzhou University

Suzhou, Jiangsu, 215008, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single oral dose of \[14C\]SHR7280

Study Record Dates

• First Submitted: May 7, 2024
• First Posted: May 10, 2024
• Study Start: June 7, 2024
• Primary Completion: July 6, 2024
• Study Completion: July 6, 2024
• Last Updated: July 22, 2024

Record last verified: 2024-07

Locations

CN (1)