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

A Single-Center, Open-Label, Single-Arm, Fixed-Sequence Phase I Clinical Study to Evaluate the Effect of Multiple Doses of Rifampin or Itraconazole on the Pharmacokinetics of VCT220 in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Vincentage Pharma Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Detailed description

This is a single-center, open-label, single-arm, fixed-sequence Phase I clinical study designed to evaluate the effect of multiple doses of rifampin or itraconazole on the pharmacokinetics (PK) of VCT220 and its primary metabolite, VCT289, in healthy subjects. The study includes two cohorts. Cohort 1 (Rifampin group): Participants will receive a single oral dose of VCT220 160 mg on Day 1. Rifampin 600 mg will be administered once daily from Day 4 to Day 10 and from Day 12 to Day 14. On Day 11, participants will receive rifampin 600 mg followed 30 minutes after breakfast by VCT220 160 mg. All doses will be administered under fed or fasting conditions as specified, with restrictions on fluid intake and fasting periods post-dose to standardize absorption conditions. Cohort 2 (Itraconazole group): Participants will receive a single oral dose of VCT220 40 mg on Day 1. Itraconazole 200 mg will be administered once daily from Day 4 to Day 11 and from Day 13 to Day 14. On Day 12, a single dose of VCT220 40 mg will be co-administered with itraconazole 200 mg after breakfast, under standardized fed conditions. A total of 32 healthy adult subjects will be enrolled, with 16 subjects per cohort.

Conditions

• Obesity &Amp; Overweight

Interventions

Type	Name	Description
DRUG	Rifampin + VCT220	Participants will receive a single oral dose of VCT220 160 mg on Day 1. Rifampin 600 mg will be administered once daily from Day 4 to Day 10 and from Day 12 to Day 14. On Day 11, rifampin 600 mg will be administered followed 30 minutes later by VCT220 160 mg. All doses are administered under fed or fasting conditions with standardized restrictions on fluid and food intake.
DRUG	Itraconazole + VCT220	Participants will receive a single oral dose of VCT220 40 mg on Day 1. Itraconazole 200 mg will be administered once daily from Day 4 to Day 11 and from Day 13 to Day 14. On Day 12, VCT220 40 mg will be co-administered with itraconazole 200 mg after breakfast. All doses are administered under fed conditions with standardized fluid and fasting controls.

Timeline

• Start date: 2025-07-20
• Primary completion: 2025-08-11
• Completion: 2025-09-30
• First posted: 2025-07-09
• Last updated: 2026-03-31

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study