A Study Evaluating Food Effect on Pharmacokinetics of HS-10518

NCT06554548 | Not Yet Recruiting Phase 1

• 1 other identifier: HS-10518-103
• Study Type: interventional
• Target: 8
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Endometriosis

Outcome Measures

Primary Outcomes (2)

• Peak plasma concentration (Cmax) of HS-10518

  predose and within 48 hours postdose in each treatment period

• Area under the plasma concentration versus time curve (AUC0-t) of HS-10518

  within 48 hours postdose in each treatment period

  within 48 hours postdose in each treatment period

Study Arms (2)

Sequence AB

EXPERIMENTAL

fasting, fed

Drug: HS-10518

Sequence BA

EXPERIMENTAL

fed, fasting

Drug: HS-10518

Interventions

HS-10518 DRUG

Treatment A: Single oral dose of HS-10518 160 mg tablet under fasted conditions Treatment B: Single oral dose of HS-10518 160 mg tablet after a high-fat meal

Sequence AB; Sequence BA

Eligibility Criteria

• Age: 18 Years - 70 Years
• Gender Eligibility Details: Premenopausal adult female subjects
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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
• Those who have consumed excessive amounts of tea, coffee, and/or caffeinated beverages within 3 months prior to screening (The average is more than 8 cups per day, 1 cup=200 mL)
• Those who have consumed grapefruit or grapefruit products within 48 hours prior to the first dose.
• Those who have consumed caffeine-rich and/or xanthine-rich foods or products (such as: coffee, tea, chocolate, and caffeinated carbonated beverages such as cola, etc.), tobacco-containing products (such as cigarettes, etc.), alcohol, or alcoholic products within 48 hours prior to the first dose.
• Those who drink regularly within 3 months before screening (i.e., drink more than 14 units of alcohol per week, 1 unit = 14 g of alcohol, equivalent to 360 mL of beer or 45 mL of spirits or 150 mL of wine with 40% alcohol, equivalent to drinking 10 bottles of beer or 1 kg of white wine or 3 bottles of red wine per week), or those who cannot stop drinking alcohol products during the study, or those who have a positive alcohol breath test result.
• Those who smoked more than 5 cigarettes per day on average within 3 months before screening, or those who could not stop using any tobacco products (including e-cigarettes) during the study.

Sponsors & Collaborators

• Jiangsu Hansoh Pharmaceutical Co., Ltd.: lead

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2024
• First Posted: August 15, 2024
• Study Start: August 15, 2024
• Primary Completion: July 30, 2025
• Study Completion: August 30, 2025
• Last Updated: August 15, 2024

Record last verified: 2024-08