The goal of this clinical trial is to learn how Sudapyridine (WX-081) tablets interact with other drugs and how food intake affects its pharmacokinetics in healthy Chinese adults. The main questions it aims to answer are:
How does itraconazole (a strong CYP3A inhibitor) affect the pharmacokinetics of Sudapyridine? How does rifampin (a strong CYP3A inducer) affect the pharmacokinetics of Sudapyridine? How does food intake influence the pharmacokinetics of Sudapyridine?
Participants will:
Take Sudapyridine alone, with itraconazole, with rifampin, and under fed and fasting conditions based on a predefined sequence.
Attend multiple clinic visits for blood sample collection and safety evaluations.
Researchers will compare the pharmacokinetic parameters of Sudapyridine under these conditions to determine the impact of drug-drug interactions and food.
Participants must be healthy male or female adults of Chinese nationality, aged 18-50 years (including 18 and 50).
Participants with central nervous system, cardiovascular, gastrointestinal, urinary, respiratory, musculoskeletal, endocrine, or hematologic diseases or other chronic/acute diseases, or those with significant surgical history affecting drug absorption, distribution, metabolism, or excretion.
Crossover
Sudapyridine
DrugIn 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.
Itraconazole
DrugIn 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.
Rifampin
DrugIn Study B: Participants will receive rifampin capsules at 600 mg orally once daily under fasting conditions during Cycle 2 (D15-D27).
Peak Plasma Concentration (Cmax) of Sudapyridine (WX-081)
Measurement of the maximum observed plasma concentration of Sudapyridine (WX-081) when administered alone, with itraconazole, with rifampin, and under fasting and fed conditions.
Time to Maximum Plasma Concentration (Tmax) of Sudapyridine (WX-081)
Measurement of the time to reach the maximum observed plasma concentration of Sudapyridine (WX-081) when administered alone, with itraconazole, with rifampin, and under fasting and fed conditions.
Area Under the Plasma Concentration-Time Curve (AUC0-t and AUC0-∞) of Sudapyridine (WX-081)
Measurement of the area under the plasma concentration-time curve from time 0 to the last measurable concentration (AUC0-t) and from time 0 extrapolated to infinity (AUC0-∞) of Sudapyridine (WX-081) when administered alone, with itraconazole, with rifampin, and under fasting and fed conditions.
Number of Participants with Treatment-Emergent Adverse Events (TEAEs) as Assessed by CTCAE v4.0
Assessment of treatment-emergent adverse events (TEAEs) using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 to evaluate safety and tolerability.
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