Pharmacokinetic Study of Sudapyridine（WX-081）in Healthy Chinese Subjects

Pharmacokinetics and Mass Balance Study of WX-081 (Sudapyridine) in Healthy Chinese Volunteers

This single-center, open-label, non-randomized study aims to evaluate the pharmacokinetics, mass balance, and metabolic pathways of WX-081 (Sudapyridine) following a single oral dose of [U-14C] WX-081 in healthy Chinese male volunteers. A total of 6-10 subjects will be enrolled to obtain complete samples and data from at least six participants. Biological samples, including blood, plasma, urine, and feces, will be collected over a specified time period. The study will assess pharmacokinetic parameters, excretion pathways, and identify major metabolites contributing to over 10% of plasma exposure.

Study Overview

• Status: Recruiting
• Conditions: TB
• Intervention / Treatment: Drug: [U-14C] WX-081

Detailed Description

The study involves healthy male volunteers who will receive a single oral dose of [U-14C] WX-081 containing approximately 450 mg (100 μCi) after fasting overnight. Samples of blood, plasma, urine, and feces will be collected during an intensive phase (up to 504 hours post-dose) and a sparse phase (up to 51 days). Pharmacokinetic and excretion parameters will be calculated, and metabolic pathways will be determined via radiolabeled metabolite profiling. Volunteers will follow pre-specified dietary and procedural requirements, including pre-dose baseline assessments and post-dose fasting. Adjustments to sample collection duration or early termination will be made based on phase-specific results. Safety monitoring will continue until sample collection is complete.

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Miao Li Yan, M.D.; Phone Number: +86-0512-67972858; Email: miaolysuzhou@163.com

Study Locations

• China
  • Jiangsu
    • Suzhou, Jiangsu, China, 215000
      • Recruiting
      • The First Affiliated Hospital of Soochow University
      • Contact: Miao Li Yan, M.D.; Phone Number: +86-0512-67972858; Email: miaolysuzhou@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Healthy adult males. Age: 18-45 years (inclusive). Body weight: BMI between 19.0 and 26.0 kg/m² (inclusive), with body weight not less than 50.0 kg.

Voluntarily signed the informed consent form. Able to communicate effectively with investigators and comply with the study protocol.

Exclusion Criteria:

• Clinically significant abnormalities identified through physical examination, vital signs, laboratory tests (e.g., blood count, biochemistry, troponin, coagulation function, urinalysis, fecal occult blood), thyroid function, 12-lead ECG, chest X-ray, rectal examination, or abdominal ultrasound (liver, gallbladder, pancreas, spleen, kidney).

Prolonged corrected QT interval (QTcF) > 450 msec on 12-lead ECG. Positive results for hepatitis B surface antigen (HBsAg or HBeAg), hepatitis C antibody (HCV-Ab), syphilis antibody, or HIV antigen/antibody (HIV-Ag/Ab).

Use of drugs that inhibit or induce hepatic enzymes or transporters within 30 days prior to screening.

Use of prescription or over-the-counter medications, herbal remedies, or dietary supplements (e.g., vitamins, calcium) within 14 days prior to screening.

Any clinically significant disease or condition that may affect study results, including but not limited to cardiovascular, respiratory, endocrine, neurological, gastrointestinal, urinary, hematological, immune, psychiatric, or metabolic disorders.

Conditions that could affect drug absorption, such as a history of gastric surgery (e.g., gastrectomy, gastric bypass), gallbladder removal, or inflammatory bowel disease.

History of organic heart disease, heart failure, myocardial infarction, angina, unexplained arrhythmia, ventricular tachycardia, atrioventricular block, long QT syndrome, or family history of sudden cardiac death due to cardiac reasons.

Major surgery within 6 months prior to screening or incomplete surgical wound healing.

Known hypersensitivity or allergy to two or more substances, or potential allergy to the investigational drug or its excipients (e.g., lactose, low-substituted hydroxypropyl cellulose, sodium lauryl sulfate, silicon dioxide, magnesium stearate).

Hemorrhoids or perianal conditions with regular or current rectal bleeding.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single Oral Dose of [U-14C] WX-081; Participants will receive a single oral dose of approximately 450 mg (100 μCi) of [U-14C] WX-081. The study involves collecting biological samples, including blood, plasma, urine, and feces, at specified time points to evaluate pharmacokinetics, metabolism, mass balance, and excretion pathways.	Drug: [U-14C] WX-081; A single oral dose of approximately 450 mg (100 μCi) of [U-14C] WX-081 will be administered to healthy male volunteers. The study will involve pharmacokinetic assessments, including metabolism, mass balance, and excretion pathways, through the collection of biological samples such as blood, plasma, urine, and feces.; Other Names: Sudapyridine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative Excretion Rate of Total Radioactivity in Urine	The cumulative percentage of total radioactivity excreted in urine and feces after a single oral dose of [U-14C] WX-081 in healthy male volunteers.	Up to Day 51 post-dose.
Cumulative Excretion Rate of Total Radioactivity in Feces	The cumulative percentage of total radioactivity excreted in feces after a single oral dose of [U-14C] WX-081 in healthy male volunteers.	Up to Day 51 post-dose.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Identification and Percentage of Major Metabolites in Plasma, Urine, and Feces	The percentage of total radioactivity in plasma attributable to the parent drug and its metabolites (≥10% of total AUC) and the percentage of dose excreted in urine and feces as the parent drug and metabolites.	Up to Day 51 post-dose

Collaborators and Investigators

• Sponsor: Shanghai Jiatan Pharmatech Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): September 4, 2024
• Primary Completion (Estimated): December 12, 2025
• Study Completion (Estimated): June 12, 2026

Study Registration Dates

• First Submitted: November 18, 2024
• First Submitted That Met QC Criteria: November 20, 2024
• First Posted (Estimated): November 22, 2024

Study Record Updates

• Last Update Posted (Estimated): November 22, 2024
• Last Update Submitted That Met QC Criteria: November 20, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: JYP0081M102

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No