Pharmacokinetic Study of Vorolanib Tablets in Trial Participants With Hepatic Impairment
Sponsor: Betta Pharmaceuticals Co., Ltd. • ClinicalTrials.gov ID: NCT07809802
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This is a single-center, non-randomized, open-label, parallel-group, single-dose study designed to evaluate the safety and pharmacokinetic (PK) profile of vorolanib tablets in participants with hepatic impairment. A total of 24 participants (male and female) will be enrolled. Three study groups will be established, comprising participants with mild hepatic impairment (Child-Pugh A), moderate hepatic impairment (Child-Pugh B), and normal hepatic function, respectively. All participants will receive a single oral dose of 200 mg vorolanib tablets after a standard breakfast (regular meal) on Day 1 (D1). PK blood sampling and safety assessments will be performed at protocol-specified time points before and after drug administration for each participant.
Interventions
-
vorolanib
(Drug)
a single oral dose of 200 mg
-
vorolanib
(Drug)
a single oral dose of 200 mg
-
Vorolanib
(Drug)
a single oral dose of 200 mg
Eligibility criteria
Conditions
Locations
- The First Hospital of Jilin University — Changchun, Jilin, China
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Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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