A Phase I Study to Evaluate the Effect of Itraconazole on the Pharmacokinetics of HS-10506 in Hea… (NCT07535970) | Clinical Trial Compass
Not Yet RecruitingPhase 1
A Phase I Study to Evaluate the Effect of Itraconazole on the Pharmacokinetics of HS-10506 in Healthy Chinese Adult Participants
China20 participantsStarted 2026-04-30
Plain-language summary
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.
Who can participate
Age range18 Years – 45 Years
SexALL
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Inclusion criteria
✓. 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).
Exclusion criteria
✕. 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;
What they're measuring
1
Evaluation of PK parameters of HS-10506: Cmax
Timeframe: 120 hours after administration of HS-10506
2
Evaluation of PK parameters of HS-10506: AUC0-t
Timeframe: 120 hours after administration of HS-10506
3
Evaluation of PK parameters of HS-10506: AUC0-∞
Timeframe: 120 hours after administration of HS-10506
✕. Current or past history of psychiatric disorders or brain dysfunction, or assessment of suicide risk using the Columbia-Suicide Severity Rating Scale (C-SSRS), or self-injurious behavior or suicide attempt within one year before screening, or current suicide risk based on the investigator's clinical judgment;
✕. Current or past history of severe gastrointestinal diseases (e.g., Crohn's disease, ulcerative colitis, reflux esophagitis, etc.);
✕. Evidence of previous ventricular dysfunction, such as congestive heart failure (CHF)or a history of CHF;
✕. History of surgery within 3 months before screening, or planned surgery during the trial period, or surgery that may affect drug absorption, distribution, metabolism, or excretion, deemed by the investigator as unsuitable for enrollment;