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NCT Number: NCT06117514

Sudapyridine (WX-081) in Healthy Volunteers

The objective of this study is to evaluate the safety, tolerability as well as pharmacokinetics of Sudapyridine (WX-081) in Chinese volunteers.

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Key information

Conditions

Healthy

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Shanghai Xuhui District Central Hospital

Shanghai, China

About this study

In this study, a single-center, randomized, double-blind, placebo-controlled, dose-ascending design was used to evaluate the safety, tolerability and pharmacokinetic characteristics of Sudapyridine (WX-081) tablets in healthy Chinese subjects using placebo as control.

This study was divided into two stages. The first stage evaluated the tolerance of single administration, pharmacokinetic characteristics, and the effect of food on PK. The second stage evaluated the tolerance of multiple administration and PK characteristics.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Weight: ≥50 kg; 19≤ body mass index (BMI) < 26 kg/m2;
  • Considered healthy by the investigator based on a detailed history, thorough physical examination, clinical laboratory examination, 12-lead ECG, and vital signs results;
  • No parenting plan and reliable contraception during the trial period and within 3 months after the last dose.

Exclusion criteria

  • Allergic to any drug of the same category or its ingredients;
  • A history of alcohol dependence or drug abuse;
  • Laboratory obvious abnormalities;
  • CYP3A4 potent inducer or inhibitor had been taken within 30 days prior to enrollment;
  • Any serious cardiovascular, kidney, liver, blood, tumor, endocrine and metabolic, autoimmune or rheumatic diseases.

Treatment and study plan

Sudapyridine 30mg

Drug

Sudapyridine capsule 30mg, orally, single dose

Other names: Sudapyridine capsule 30mg SAD

Sudapyridine 100mg SAD

Drug

Sudapyridine tablet, 100mg orally, single dose

Other names: Sudapyridine tablet 100mg SAD

Sudapyridine 200mg SAD

Drug

Sudapyridine tablet, 200mg orally, single dose

Other names: Sudapyridine tablet 200mg SAD

Sudapyridine 200mg MAD

Drug

Sudapyridine tablet, 200mg orally once a day for 14 days

Other names: Sudapyridine tablet 200mg MAD

Sudapyridine 300mg MAD

Drug

Sudapyridine tablet, 300mg orally once a day for 14 days

Other names: Sudapyridine tablet 300mg MAD

Placebo tablet SAD

Other

Placebo tablet, 100mg orally, single dose

Other names: Placebo tablet 100mg

Placebo 200mg SAD

Other

Placebo tablet, 200mg orally, single dose

Placebo tablet MAD

Other

Placebo tablet, 200mg orally once a day for 14 days

Other names: Placebo tablet 200mg MAD

Primary outcomes

  1. Maximum plasma concentration (Cmax) of Sudapyridine

    Time frame: 0,1,2,3,4,6,8,12,24,48,72,96,120,144 hours post-dose

    PK parameter

  2. Time to reach plasma Cmax (Tmax) of Sudapyridine

    Time frame: 0,1,2,3,4,6,8,12,24,48,72,96,120,144 hours post-dose

    PK parameter

  3. Area under the plasma concentration-time curve (AUC) of Sudapyridine

    Time frame: 0,1,2,3,4,6,8,12,24,48,72,96,120,144 hours post-dose

    PK parameter

  4. Terminal elimination half-life (t½) of Sudapyridine

    Time frame: 0,1,2,3,4,6,8,12,24,48,72,96,120,144 hours post-dose

    PK parameter

  5. Volume of distribution (Vd/F) of Sudapyridine

    Time frame: 0,1,2,3,4,6,8,12,24,48,72,96,120,144 hours post-dose

    PK parameter

  6. Apparent clearance (CL/F) of Sudapyridine

    Time frame: 0,1,2,3,4,6,8,12,24,48,72,96,120,144 hours post-dose

    PK parameter

  7. Elimination rate constant Ke of Sudapyridine

    Time frame: 0,1,2,3,4,6,8,12,24,48,72,96,120,144 hours post-dose

    PK parameter

  8. Number of participants with adverse events (AEs) or Serious Adverse Events (SAEs)

    Time frame: 0,1,2,3,4,6,8,12,24,48,72,96,120,144 hours post-dose

    safety parameter

Sponsors and collaborators

Lead sponsor

Shanghai Jiatan Pharmatech Co., Ltd

Industry

Registry information

Official study title

A Single-center, Randomized, Double-blind, Placebo-controlled, Dose-ascending Phase I Trial to Evaluate the Safety, Tolerability, and Pharmacokinetic Characteristics of Sudapyridine (WX-081) Tablets in Healthy Chinese Subjects

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Nov 7, 2023
Registry last updated
Nov 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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