A single-center, open-label, fixed-sequence, self-controlled phase I clinical trial aimed at evaluating the effect of itraconazole capsules(CYP3A inhibitor) on the pharmacokinetics of HS-10506 tablets in healthy participants.
Sign the informed consent form before the trial, fully understand the trial content, procedures, and possible adverse events, and self-report the ability to complete the study in accordance with the trial regulations;
Adult males and females (aged between 18 and 45 years, inclusive of boundary values, calculated on the date of signing the informed consent form);
Participant's Body Mass Index (BMI) = weight (kg) / height² (m²) within the range of 19.0-26.0 kg/m² (inclusive of boundary values); male participants weigh ≥ 50 kg, female participants weigh ≥ 45 kg;
Agree to practice highly effective contraception from the signing of the informed consent form until 3 months after the last dose, and have no plans for pregnancy or sperm/egg donation during this period (only non-drug contraceptive measures are permitted during the trial).
Those with clinically significant abnormalities in physical examination, vital signs, oxygen saturation, 12-lead electrocardiogram, clinical laboratory tests, etc., deemed by the investigator as unsuitable for enrollment;
Positive results for any one or more of hepatitis B surface antigen, hepatitis C antibody, human immunodeficiency virus antibody, or Treponema pallidum(TP)specific antibody during the screening period;
12-lead electrocardiogram results during the screening period showing QTcF>450.00 ms for males or QTcF>470.00 ms for females;
Previous or current presence of severe diseases of the nervous system, psychiatric system, digestive system, circulatory system, respiratory system (e.g., anatomical abnormalities of the airway, congenital microstomia with macroglossia, mandibular hypoplasia; chronic obstructive pulmonary disease or sleep apnea syndrome), urinary system, endocrine and metabolic system, immune system, hematological system, etc., assessed by the investigator as unsuitable for participation in this study;
Single group
HS-10506, Itraconazole
DrugHS-10506: Administered under fasting conditions in the morning. Itraconazole: Itraconazole capsules (0.2 g) are taken orally once daily for nine consecutive days.
Evaluation of PK parameters of HS-10506: Cmax
To evaluate the Cmax of HS-10506 administered alone and in combination with Itraconazole in healthy participants.
Evaluation of PK parameters of HS-10506: AUC0-t
To evaluate the AUC0-t of HS-10506 administered alone and in combination with Itraconazole in healthy participants.
Evaluation of PK parameters of HS-10506: AUC0-∞
To evaluate the AUC0-∞ of HS-10506 administered alone and in combination with Itraconazole in healthy participants.
Evaluation of PK parameters of HS-10506:Tmax
To evaluate the Tmax of HS-10506 administered alone and in combination with Itraconazole in healthy participants.
Evaluation of PK parameters of HS-10506: t1/2z
To evaluate the t1/2z of HS-10506 administered alone and in combination with Itraconazole in healthy participants
Evaluation of PK parameters of HS-10506: λz
To evaluate the λz of HS-10506 administered alone and in combination with Itraconazole in healthy participants.
Evaluation of PK parameters of HS-10506: CL/F
To evaluate the CL/F of HS-10506 administered alone and in combination with Itraconazole in healthy participants.
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