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A Study Evaluating the Effects of Itraconazole or Rifampin on the Pharmacokinetic Characteristics of Rocbrutinib Tablet

NCT07374224 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2026-03-09

No results posted yet for this study

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.

Conditions

  • Clinical Pharmacology

Interventions

DRUG

Rocbrutinib tablets

Dosage form: tablets Specification: 100 mg Dosage and administration: 100mg or 200mg, single dose, taken on the designated day according to the treatment plan. Dosage schedule: Depending on the cohort, subjects will need to take Rocbrutinib 2 times (inhibitor cohort) or 3 times (inducer cohort) during the study period.

DRUG

Itraconazole capsules

Dosage form: Capsules Specifications: 0.1g Dosage and administration: Take 400 mg (4\*100 mg capsules) on Day 5, followed by 200 mg (2 100 mg capsules) once daily (QD) from Day 6 to Day 12. Duration of medication: The medication was administered for a total of 8 days during the study period.

DRUG

Rifampicin capsules

Dosage form: Capsules Specifications: 0.15g Dosage and administration: Day 4-Day 12, take 600 mg (4 150 mg capsules) once daily (QD). Duration of medication: The medication was administered for a total of 9 days during the study period.

Sponsors & Collaborators

  • Guangzhou Lupeng Pharmaceutical Company LTD.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-03-05
Primary Completion
2026-06-30
Completion
2026-08-30
FDA Drug
Yes

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07374224 on ClinicalTrials.gov