Assisted Reproduction, Endometriosis, Uterine Fibroids
Conditions
Brief summary
The study is being conducted to evaluate the effect of high-fat meal on pharmacokinetics of SHR7280 after oral administration and the effect of SHR7280 on QT interval at low and high doses in healthy Chinese volunteers.
Interventions
DRUGSHR7280 Tablet
Oral SHR7280 tablet.
DRUGSHR7280 Placebo Tablet
Oral SHR7280 placebo tablet.
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. Voluntarily sign the informed consent form prior to any activities in the trail, demonstrate comprehension of the trial procedures and methodology, and agree to strictly adhere to the protocol throughout the study period. 2. Be aged between 18 and 45 years inclusive (determined at the time of signing the informed consent form). 3. Have a body weight of ≥50 kg for males and ≥45 kg for females, with a Body Mass Index (BMI) between 18 and 26 kg/m² inclusive. 4. Have no plans for pregnancy or sperm/egg donation from the time of signing the inform consent form until 1 week after the last administration of the investigational product, and agree to use highly effective contraceptive measures.
Exclusion criteria
1. Individuals with a history of chronic or serious diseases, or current conditions affecting the respiratory, circulatory, digestive, urinary, hematological, endocrine, immune, nervous, or psychiatric systems, and deemed ineligible to participate in this trial by the investigator. 2. Females who are pregnant, breastfeeding, or with a positive serum pregnancy test during the screening or baseline period. 3. History of smoking (average daily cigarette consumption \>5 cigarettes) within 3 months prior to randomization, or any use of tobacco products during the study period. 4. History of drug abuse, positive urine drug abuse screen at the screening period. 5. Receipt of live (attenuated) vaccines within 1 month prior to screening or planned administration during the trial (excluding influenza vaccines). 6. Undergoing any surgical procedure within 3 months prior to randomization, incomplete recovery from surgery, or anticipated need for surgery or hospitalization during the trial period. 7. Inability to comply with standardized dietary requirements, intolerance to high-fat meals, or presence of dysphagia. 8. Any condition judged by the investigator to potentially affect drug absorption, distribution, metabolism, or excretion, reduce compliance, or pose other risks that make participation in the study inappropriate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Peak concentration (Cmax) | Day 1 to Day 8. |
| Area under the plasma concentration-time curve from time 0 to the last quantifiable timepoint (AUC0-t) | Day 1 to Day 8. |
| Area under the plasma concentration-time curve from time 0 to infinity (AUC0-∞) | Day 1 to Day 8. |
Secondary
| Measure | Time frame |
|---|---|
| Time to peak concentration (Tmax) | Day 1 to Day 8. |
| Elimination half-life (t1/2) | Day 1 to Day 8. |
| Adverse events (AEs) | Day 1 to Day 15. |
Countries
China
Outcome results
None listed