Rifampicin-Resistant Pulmonary Tuberculosis PatientsPhase 1WX081-DDINCT06701136
Drug-Drug Interaction and Food Effect of Sudapyridine(WX-081) With Itraconazole and Rifampin in Healthy Chinese Adults
A Phase 1 study testing Sudapyridine, Itraconazole and Rifampin in people with Rifampicin-Resistant Pulmonary Tuberculosis Patients, run by Shanghai Jiatan Pharmatech Co., Ltd.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Rifampicin-Resistant Pulmonary Tuberculosis Patients
- What is being tested?
- Sudapyridine, Itraconazole and Rifampin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- 12 May 2025to 12 Feb 2026
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants must be healthy male or female adults of Chinese nationality, aged 18-50 years (including 18 and 50).
- Male participants must weigh at least 50 kg, and female participants at least 45 kg. Body mass index (BMI) should be between 18 and 28 kg/m² (including 18 and 28), and weight (kg)/height (m²).
- Participants must undergo a comprehensive physical examination, 12-lead ECG, vital signs assessment, and laboratory tests. Results must be normal or deemed clinically insignificant by the investigator, meeting the following:
- 12-lead ECG must show QTcF ≤ 450 ms (≤ 200 ms for A Study), QRS duration ≤ 120 ms, and PR interval ≤ 200 ms. PR elongation may allow entry if deemed clinically insignificant by the investigator.
- Participants (including their partners) must agree to use effective contraception from the date of screening to 6 months after the last study drug administration and must avoid sperm/egg donation during this period.
Who cannot join
- 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.
- Participants with conditions that increase the risk of QT prolongation, or with a family history of sudden cardiac death (<40 years old) or other hereditary diseases.
- Clinically significant laboratory abnormalities at screening, including:
- ALT/AST/TBIL values exceeding 2 times the upper limit of normal. Estimated creatinine clearance (ClCr) < 60 mL/min. Participants with urinary system disorders. Use of any prescription or over-the-counter drugs, supplements, or herbal products within 2 weeks before dosing that may affect the study evaluation.
- Known allergy to Sudapyridine (WX-081) or other related compounds. Participants positive for hepatitis B surface antigen (HBsAg), anti-hepatitis C virus antibody (Anti-HCV), anti-HIV antibody, or syphilis antibody.
- History of alcohol or drug abuse:
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- Alcohol: ≥14 units per week; a unit equals 285 mL beer or 100 mL wine. Participants who smoke more than 5 cigarettes/day and cannot stop during the study.
- Donation of blood exceeding 400 mL within 1 month prior to the study. Participants enrolled in other drug trials within 3 months before the study. Use of CYP3A4 or P-gp inhibitors/inducers within 28 days prior to the study (e.g., itraconazole, rifampin).
- Unwillingness to avoid grapefruit, pomelo, or other food/drinks affecting drug metabolism during the study.
- Participants with a history of intestinal surgery affecting drug absorption. Women who are pregnant or lactating or intending to become pregnant. Participants deemed unsuitable by the investigator due to other reasons.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Clinical Study to Evaluate the Drug-Drug Interaction and Food Effect of Sudapyridine(WX-081) Tablet With Itraconazole and Rifampin in Healthy Chinese Adult Volunteers
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?
Read more
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.
Read the detailed description
This open-label, single-center, interventional clinical study aims to assess the pharmacokinetics, safety, and tolerability of Sudapyridine (WX-081) tablets when administered with itraconazole, rifampin, and under fed and fasting conditions in healthy Chinese adults.
The primary objectives are:
To evaluate the effects of itraconazole, a potent CYP3A inhibitor, on the pharmacokinetics of Sudapyridine.
To assess the impact of rifampin, a strong CYP3A inducer, on the pharmacokinetics of Sudapyridine.
To investigate the influence of food on the pharmacokinetics of Sudapyridine. The study will adopt a crossover design with participants assigned to various treatment sequences to ensure comprehensive evaluation of the drug-drug interactions and food effects. The secondary objectives include determining safety profiles and providing key insights for dose adjustments and clinical use of Sudapyridine in subsequent trials.
The results from this trial will contribute to understanding the pharmacokinetic and safety characteristics of Sudapyridine, supporting its further clinical development.
- Being tested
- Sudapyridine, Itraconazole, Rifampin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SudapyridineDrug
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.
ItraconazoleDrug
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.
RifampinDrug
In Study B: Participants will receive rifampin capsules at 600 mg orally once daily under fasting conditions during Cycle 2 (D15-D27).
| Study group | Role | What they receive |
|---|---|---|
| Sudapyridine (WX-081) Alone | Experimental | Participants will receive Sudapyridine (WX-081) tablets orally at a specified dose once daily for 10 days (in Study A and Study B) or once under fasting and fed conditions (in Study C). Pharmacokinetic sampling and safety assessments will be conducted. Receives: Drug: Sudapyridine |
| Sudapyridine (WX-081) Combined with Itraconazole or Rifampin | Experimental | Participants will receive Sudapyridine (WX-081) tablets orally at a specified dose once daily for 7 days while co-administered with itraconazole (Study A) or rifampin (Study B). Pharmacokinetic sampling and safety assessments will be conducted. Receives: Drug: Sudapyridine; Drug: Itraconazole; Drug: Rifampin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From pre-dose Day 1 to Day 7 until post-dose Day 15 to Day 21
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.
Measured: From pre-dose Day 1 to Day 7 until post-dose Day 15 to Day 21
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.
Measured: From pre-dose Day 1 to Day 7 until post-dose Day 15 to Day 21
Secondary outcomes (1)
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.
Measured: From Day 1 to 7 days post-last dose (up to 35 days, depending on the study part).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2024
- Study start12 May 2025 (estimated)
- Primary completion12 Oct 2025 (estimated)
- Study completion12 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rifampicin-Resistant Pulmonary Tuberculosis PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiatan Pharmatech Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06701136
- Sponsor's protocol ID
- JYP0081M103
- Other IDs
- CTR20221162
- Acronym
- WX081-DDI
- Status last verified
- Feb 2025
- First submitted
- 18 Nov 2024
- Last updated
- 12 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No