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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Arm | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rifampin + VCT220 | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Area under plasma concentration-time curve from time zero to infinity (AUC) for VCT220. | Rifampin Cohort | 1 hour pre-dose on D1 and D11, and 0.5h, 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, 72h post dose |
| Area under plasma concentration-time curve from time zero to infinity (AUC) for VCT220 | Itraconazole Cohort | 1 hour pre-dose on D1 and D12, and 0.5h, 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, 72h post dose |
| Maximum observed plasma concentration (Cmax) for VCT220 | Rifampin Cohort | 1 hour pre-dose on D1 and D11, and 0.5h, 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, 72h post dose |
| Maximum observed plasma concentration (Cmax) for VCT220 | Itraconazole Cohort | 1 hour pre-dose on D1 and D12, and 0.5h, 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, 72h post dose |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events | From the 1st dosing day and 1-2 days after last treatment (day 15) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Shandong First Medical University | Jinan | Shandong | 250014 | China |
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|
| Itraconazole + VCT220 | Drug | 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. |
|
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D012293 | Rifampin |
| D017964 | Itraconazole |
| ID | Term |
|---|---|
| D012294 | Rifamycins |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D047029 | Lactams, Macrocyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D010879 | Piperazines |
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