A Study Evaluating the Effects of Itraconazole or Rifampin on the Pharmacokinetic Characteristics… (NCT07374224) | Clinical Trial Compass
RecruitingPhase 1
A Study Evaluating the Effects of Itraconazole or Rifampin on the Pharmacokinetic Characteristics of Rocbrutinib Tablet
China28 participantsStarted 2026-03-05
Plain-language summary
This is a phase I, open-label, two-part, fixed-sequence drug interaction study conducted to evaluate the effects of concomitant use of the potent CYP3A4 inhibitor itraconazole or the CYP3A4 inducer rifampin on the pharmacokinetics of Rocbrutinib in healthy subjects.
Who can participate
Age range18 Years – 45 Years
SexALL
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Inclusion Criteria:
* Subjects had no history of serious digestive system (such as inflammatory bowel disease, chronic diarrhea, Crohn's disease, autonomic dysfunction affecting gastric emptying), nervous system, cardiovascular system, genitourinary system, respiratory system, metabolic and endocrine system, musculoskeletal system, hematologic system diseases, or tumors
* Subjects must agree to complete abstinence or use effective physical contraception (including sterilization, intrauterine device or barrier contraception) from the time of signing the informed consent form until 90 days after the last dose of medication, and have no plans to donate sperm or eggs during this period; if female subjects are using hormonal contraceptives, they must stop using them \>14 days before the first dose and use at least one of the above contraceptive methods.
* Must be between 18 and 45 years old (inclusive) and be male or female when signing the informed consent form.
* Males weighing ≥50.0 kg or females weighing ≥45.0 kg, with a Body Mass Index (BMI) between 18.0 and 28.0 kg/m² (inclusive). BMI = weight (kg) / height² (m²).
* Able to understand and comply with the requirements of the research plan.
* Voluntarily participate in this study and sign the informed consent form.
Exclusion Criteria:
* Abnormalities in screening tests, such as vital signs, physical examination, or laboratory tests are clinically significant and may increase the risk of participants participating in the stu…
What they're measuring
1
AUC
Timeframe: Until 72 hours or 96 hours after Rocbrutinib
2
Cmax
Timeframe: Until 72 hours or 96 hours after Rocbrutinib
3
t1/2
Timeframe: Until 72 hours or 96 hours after Rocbrutinib
Trial details
NCT IDNCT07374224
SponsorGuangzhou Lupeng Pharmaceutical Company LTD.