A Drug-Drug Interaction Study Between HS-10374 Tablets and Drospirenone and Ethinyl Estradiol Tablets(Yasmin®)

Hansoh Pharma

Status and phase

Completed

Phase 1

Conditions

Psoriasis (PsO)

Treatments

Drug: HS-10374 tablets

Drug: Drospirenone and Ethinyl Estradiol tablets

Study type

Interventional

Funder types

Industry

Identifiers

NCT07181343

HS-10374-118

Details and patient eligibility

About

This trial is a single-center, open-label, fixed-sequence, self-controlled clinical study to evaluate Drug-Drug Interaction Between HS-10374 Tablets and Drospirenone and Ethinyl Estradiol Tablets (Yasmin®)

Full description

This trial is a single-center, open-label, fixed-sequence, self-controlled clinical study. On Day 1 and Day 14, participants will orally take one tablet of Drospirenone and Ethinylestradiol Tablets (containing Drospirenone 3 mg and Ethinylestradiol 0.03 mg) under fasting conditions. From Day 8 to Day 19, participants will orally take HS-10374 Tablets 12 mg once daily under fasting conditions. Both drugs should be administered with approximately 240 mL of water.

Enrollment

18 patients

Sex

Female

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Participants who sign the informed consent form before the trial, fully understand the trial content, procedures, and potential adverse reactions, and voluntarily commit to complying with all trial requirements.
Healthy female participants aged 18 to 40 years (inclusive), with age calculated based on the date of signing the informed consent.
Participants weighing ≥45 kg, with a body mass index (BMI) ranging from 19.0 to 26.0 kg/m² (inclusive). BMI = weight (kg) / height² (m²).
Participants who agree to abstain from conception/donation of oocytes and practice complete abstinence from signing the informed consent until 40 days after the last dose.

Exclusion criteria

Participants with clinically significant abnormalities in physical examination, vital signs, ECG, clinical laboratory tests, abdominal ultrasound, gynecological color ultrasound, or breast color Doppler ultrasound, as judged by the investigator.
Positive results for any of the following during screening: Hepatitis B surface antigen (HBsAg), hepatitis C antibody, HIV antibody/p24 antigen, or Treponema pallidum antibody.
Screening values exceeding 1.5×ULN for ALT, AST, or creatine kinase (CK), with clinical significance per investigator assessment.
Screening serum creatinine >1×ULN, judged clinically significant by the investigator.
QT interval prolongation on 12-lead ECG during screening (QTcF ≥470 ms).
History of myopathy or rhabdomyolysis.
Severe pre-existing or current diseases affecting the nervous, psychiatric, digestive, circulatory, respiratory, urinary, cardiovascular, or immune systems-or any newly diagnosed condition prior to dosing-deemed by the investigator to contraindicate participation; including history of gastrointestinal disorders (e.g., gastric ulcer, reflux esophagitis).
History of tuberculosis (TB).
Current or previous history of: Venous thromboembolism (e.g., deep vein thrombosis, pulmonary embolism), Cerebrovascular disorders, Coronary artery disease, hypertension, Thrombogenic cardiac valvulopathy or rhythm disorders (e.g., subacute bacterial endocarditis with valvular disease, atrial fibrillation), Hereditary/acquired hypercoagulable states (e.g., Factor V Leiden mutation family history), Diabetes with vascular complications, Headaches with focal neurological symptoms, Migraine (with or without aura), Cholestatic jaundice and/or pruritus during prior hormone therapy.
Current or previous renal impairment or adrenal insufficiency.
Undiagnosed abnormal uterine/vaginal bleeding.
Current or previous estrogen/progestin-sensitive cancers (e.g., breast cancer).
Benign/malignant liver tumors or severe liver disease with safety risks per investigator judgment.
Active/latent TB infection during screening, assessed by: T-SPOT.TB (interferon-gamma release assay),Chest X-ray. Exclusion if: Chest X-ray shows TB lesions OR T-SPOT.TB positive.
Severe infections ≤30 days before screening (e.g., cellulitis, pneumonia, sepsis) OR herpes zoster within 3 months prior.
Participants who have undergone surgery affecting drug absorption, distribution, metabolism, or excretion, deemed ineligible by the investigator.
Individuals with a history of hypersensitivity or allergic predisposition (e.g., to pollen, ≥2 drugs/foods), or known allergy to: Active ingredients/excipients of the investigational products (Drospirenone and Ethinylestradiol Tablets & HS-10374 Tablets), Other Janus Kinase (JAK) inhibitors.
Participation in any other clinical trial involving investigational drugs/devices within 3 months prior to screening .
Blood donation or significant blood loss (>400 mL) within 3 months before screening, or plans to donate blood during the trial or within 1 month after completion .
Ingestion of grapefruit or grapefruit products within 48 hours before the first dose of investigational products .
Excessive consumption of tea, coffee, or caffeine-containing beverages (>8 cups/day on average; 1 cup=200 mL) within 3 months prior to screening .
Participants who smoked ≥1 cigarette/day within 3 months before screening, were unable to quit tobacco products during the trial, or tested positive for nicotine.
Participants who drank alcohol frequently (>14 units/week, 1 unit =14 g alcohol) within 3 months before screening, couldn't stop using alcohol during the trial, or tested positive for alcohol in breath tests.
Participants who used alcohol-containing products within 24 h before taking the test drug or had a positive alcohol breath test result.
Participants with a history of drug abuse, dependence, or illicit drug use within 5 years before screening, or tested positive for drug abuse in urine tests.
Participants who used drugs affecting liver metabolic enzymes (CYP3A, CYP1A2, CYP2D6, CYP2B6) or P-gp/BCRP activity, HIV/HCV protease inhibitors, non-nucleoside reverse transcriptase inhibitors, or hormonal drugs within 30 days before the first test drug dose.
Participants who used long-acting estrogen/progestin injectables or implants within 12 months before the first dose, or transdermal contraceptives or intrauterine devices with hormones within 3 months before enrollment.
Participants who used drugs altering gastric pH (e.g., rebamipide, omeprazole, lansoprazole, ranitidine, aluminum hydroxide) within 30 days before screening.
Participants who used prescription drugs, OTC drugs, herbs, or health products (excluding local-acting topical agents) within 14 days before screening.
Participants who used vaccines within 14 days before screening or planned to use them during or within two weeks after the trial.
Participants who tested positive for pregnancy or were breastfeeding at screening.
Participants who had unprotected sex within 14 days before screening.
Participants unable to tolerate venipuncture/indwelling needle blood collection or with a history of fainting at the sight of blood.
Participants unlikely to complete the trial for other reasons or deemed unsuitable by the investigator.