A Study Evaluating Food Effect on Pharmacokinetics of HS-10518

Jiangsu Hansoh Pharmaceutical Co., Ltd.0 sites8 target enrollmentAugust 15, 2024

ConditionsEndometriosis

InterventionsHS-10518

Overview

Phase: Phase 1
Intervention: HS-10518
Conditions: Endometriosis
Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.
Enrollment: 8
Primary Endpoint: Peak plasma concentration (Cmax) of HS-10518
Status: Not yet recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

The primary objective of this study is to evaluate the effect of food on the pharmacokinetics of HS-10518

Registry

clinicaltrials.gov

Start Date

August 15, 2024

End Date

August 30, 2025

Last Updated

last year

Study Type

Interventional

Study Design

Crossover

Sex

Female

Investigators

Sponsor

Jiangsu Hansoh Pharmaceutical Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Sign the informed consent before the study procedure，and fully understand the test contents, process and possible adverse reactions, be able to complete the study in accordance with the study regulations.
•Premenopausal adult female subjects (age ≥18 years old, calculated on the day of signing the informed consent).
•female subjects weigh at least 45 kg. Body mass index (BMI) = body weight (kg) / height 2 (m2), body mass index is in the range of 18.0 \~ 28.0 (including the critical value).
•agreed to use effective contraception from signing the informed consent until 3 months after the last dose of medication and not plan to have a child during the study, not plan to donate oocytes within 6 months after the last dose (only nonpharmacologic contraception could be used during the study).

Exclusion Criteria

•Her/his Physical examination, vital signs examination, electrocardiogram or clinical laboratory examination, etc., are abnormal and clinically meaningful according to the investigator's judgment.
•Hepatitis B surface antigen (HBsAg), hepatitis C antibody (anti-HCV), HIV antibody (anti-HCV) HIV antibody (anti-HIV) positive at screening
•Those with alanine aminotransferase (Alter) and aspartate aminotransferase (Aster) exceeded the upper limit of normal values at screening
•Those with abnormal and clinically significant ECG results (e.g., QTcF ≥ 450 ms) at screening
•Those with a prior history of breast cancer, genitourinary cancer, any estrogen-dependent tumor, or any other clinically significant gynecological disease
•Subjects with a history of osteoporosis
•Those with a history of migraine, epilepsy, convulsions, depression, or clinically significant depressive state
•Those with a history of thyroid or parathyroid dysfunction or thyroid-stimulating hormone (TSH), free triiodothyronine (FT3) and free thyroxine (FT4) exceeded the upper limit of normal values at screening
•Clinically significant gastrointestinal complaints within 7 days before the first dose
•Those who have a history of severe gastrointestinal diseases (such as Crohn's disease, ulcerative colitis, reflux esophagitis, chronic gastritis, etc.) or a history of surgery that may affect the absorption, distribution, metabolism and excretion of the trial drug (except for simple appendectomy or hernia surgery), and judged by the investigator unsuitable for enrollment