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

NCT06701136 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2025-02-12

No results posted yet for this study

Summary

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.

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).

Sponsors & Collaborators

  • Shanghai Jiatan Pharmatech Co., Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-05-12
Primary Completion
2025-10-12
Completion
2026-02-12

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06701136 on ClinicalTrials.gov