Drug-Drug Interaction and Food Effect of Sudapyridine(WX-081) With Itraconazole and Rifampin in Healthy Chinese Adults

PHASE1Not yet recruitingINTERVENTIONAL
Enrollment

16

Participants

Timeline

Start Date

May 12, 2025

Primary Completion Date

October 12, 2025

Study Completion Date

February 12, 2026

Conditions
Rifampicin-Resistant Pulmonary Tuberculosis Patients
Interventions
DRUG

Sudapyridine

In Study A, Cycle 1 (D1-D10): Participants will take Sudapyridine (WX-081) 300 mg once daily after breakfast. Cycle 2 (D11-D14): Participants will take Sudapyridine 300 mg once daily after breakfast with itraconazole 200 mg daily; an additional itraconazole dose (200 mg) will be given after dinner on D11. In Study B, Cycle 1 (D1): Participants will take Sudapyridine 450 mg as a single dose after breakfast. Cycle 2 (D22): Participants will take Sudapyridine 450 mg with rifampin 600 mg daily (D15-D27). In Study C, Cycle 1 (D1): Sudapyridine 450 mg will be given fasting; Cycle 2 (D15): after a high-fat breakfast.

DRUG

Itraconazole

In Study A: Participants will receive itraconazole capsules at 200 mg orally once daily after breakfast during Cycle 2 (D11-D14). An additional dose of itraconazole (200 mg) will be administered after dinner on D11.

DRUG

Rifampin

In Study B: Participants will receive rifampin capsules at 600 mg orally once daily under fasting conditions during Cycle 2 (D15-D27).

All Listed Sponsors
lead

Shanghai Jiatan Pharmatech Co., Ltd

INDUSTRY

NCT06701136 - Drug-Drug Interaction and Food Effect of Sudapyridine(WX-081) With Itraconazole and Rifampin in Healthy Chinese Adults | Biotech Hunter | Biotech Hunter