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Drug-Drug Interaction Study of Vorolanib Tablets in Healthy Participants

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This study adopts a single-center, open-label, same-subject sequential crossover clinical trial design, aiming to evaluate the effects of oral administration of rifampicin or itraconazole on the pharmacokinetic profiles of vorolanib tablets in healthy trial participants. The study consists of two treatment groups. The rifampicin group is planned to enroll 18 healthy trial participants. Participants will receive a single oral dose of vorolanib tablets on the morning of Day 1, and continuous oral administration of rifampicin every morning from Day 6 to Day 17. On the morning of Day 15, participants will take vorolanib tablets and rifampicin. The itraconazole group is planned to enroll 18 healthy trial participants to evaluate the effect of itraconazole on the pharmacokinetic profiles of vorolanib tablets. Participants will receive a single oral dose of vorolanib tablets on the morning of Day 1, and continuous oral administration of itraconazole every morning from Day 6 to Day 13. On the morning of Day 9, participants will take vorolanib tablets and itraconazole.
Trial Details
NCT Number NCT07809789
Lead Sponsor Betta Pharmaceuticals Co., Ltd.
Conditions DDI (Drug-Drug Interaction)
Enrollment 36 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov