drugset / Trial / NCT07056842

This is an Open-label, Non-randomized Study to Assess the Pharmacokinetics (PK) of VCT220 in Healthy Volunteers When Administered With Rifampin or Itraconazole

NCT07056842

Phase 1 Completed 32 enrolled Vincentage Pharma Co., Ltd
Non-randomizedSequentialOpen-labelTreatment

Summary

This is a single-center, open-label, single-arm, fixed-sequence Phase I study in healthy participants to evaluate the effect of multiple doses of rifampin or itraconazole on the pharmacokinetics (PK) of VCT220 and its metabolite VCT289. Cohort 1 will assess the impact of rifampin (600 mg once daily) on VCT220 (160 mg single dose). Cohort 2 will assess the impact of itraconazole (200 mg once daily) on VCT220 (40 mg single dose). A total of 32 healthy subjects will be enrolled, 16 in each cohort.

Timeline

Start
2025-07-20
Primary completion
2025-08-11
Completion
2025-09-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Itraconazole Small molecule 200 mg
Subject Rifampin Small molecule 600 mg
Subject VCT220 Small molecule 40 mg Oral
Subject VCT220 Small molecule 160 mg Oral

Indications