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RECRUITING
NCT07374224
PHASE1

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

Sponsor: Guangzhou Lupeng Pharmaceutical Company LTD.

View on ClinicalTrials.gov

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.

Official title: A Phase I, Open-label, Two-part, Fixed-sequence Drug Interaction Study to Evaluate the Effects of Concomitant Use of the CYP3A4 Inhibitor Itraconazole or the CYP3A4 Inducer Rifampin on the Pharmacokinetics of Rocbrutinib in Healthy Subjects

Key Details

Gender

All

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

28

Start Date

2026-03-05

Completion Date

2026-08-30

Last Updated

2026-03-09

Healthy Volunteers

Yes

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.

Locations (1)

Peking University Third Hospital

Beijing, Beijing Municipality, China