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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06701136
- Acronym / sponsor ID
- WX081-DDI / JYP0081M103
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Shanghai Jiatan Pharmatech Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 12 May 2025 (estimated)
- Primary completion
- 12 Oct 2025 (estimated)
- Study completion
- 12 Feb 2026 (estimated)
- First posted
- 22 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sudapyridine (WX-081) Alone | Experimental | Drug: SudapyridineParticipants 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. |
| Sudapyridine (WX-081) Combined with Itraconazole or Rifampin | Experimental | Drug: Sudapyridine, Drug: Itraconazole, Drug: RifampinParticipants 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SudapyridineIn 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 | Sudapyridine (WX-081) Alone, Sudapyridine (WX-081) Combined with Itraconazole or Rifampin |
| ItraconazoleIn 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 | Sudapyridine (WX-081) Combined with Itraconazole or Rifampin |
| RifampinIn Study B: Participants will receive rifampin capsules at 600 mg orally once daily under fasting conditions during Cycle 2 (D15-D27). | Drug | Sudapyridine (WX-081) Combined with Itraconazole or Rifampin |
Primary outcome
Peak Plasma Concentration (Cmax) of Sudapyridine (WX-081)
Time frame: From pre-dose Day 1 to Day 7 until post-dose Day 15 to Day 21
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)
Time frame: From pre-dose Day 1 to Day 7 until post-dose Day 15 to Day 21
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)
Time frame: From pre-dose Day 1 to Day 7 until post-dose Day 15 to Day 21
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.
1 secondary outcome
Number of Participants with Treatment-Emergent Adverse Events (TEAEs) as Assessed by CTCAE v4.0
Time frame: From Day 1 to 7 days post-last dose (up to 35 days, depending on the study part).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Sudapyridine, Itraconazole and Rifampin in people with Rifampicin-Resistant Pulmonary Tuberculosis Patients, run by Shanghai Jiatan Pharmatech Co., Ltd.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Li Xiao Jiao, M.D. (+86-0431-88782013, xingxingsuo123456@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak Plasma Concentration (Cmax) of Sudapyridine (WX-081) (time frame: From pre-dose Day 1 to Day 7 until post-dose Day 15 to Day 21). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2025.