Sudapyridine (WX-081) in Healthy Volunteers

Healthy Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06117514
• Other study ID #: JYB0101
• Status: Completed
• Phase: Phase 1
• Start date: February 13, 2019
• Est. completion date: July 2, 2020

Study information

• Verified date: October 2023
• Source: Shanghai Jiatan Pharmatech Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: July 2, 2020
• Est. primary completion date: July 2, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Sudapyridine 30mg
Sudapyridine capsule 30mg, orally, single dose
• Sudapyridine 100mg SAD
Sudapyridine tablet, 100mg orally, single dose
• Sudapyridine 200mg SAD
Sudapyridine tablet, 200mg orally, single dose
• Sudapyridine 200mg MAD
Sudapyridine tablet, 200mg orally once a day for 14 days
• Sudapyridine 300mg MAD
Sudapyridine tablet, 300mg orally once a day for 14 days

Other:
• Placebo tablet SAD
Placebo tablet, 100mg orally, single dose
• Placebo 200mg SAD
Placebo tablet, 200mg orally, single dose
• Placebo tablet MAD
Placebo tablet, 200mg orally once a day for 14 days
• Placebo tablet MAD
Placebo tablet, 300mg orally once a day for 14 days

Locations

Country	Name	City	State
China	Shanghai Xuhui District Central Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Jiatan Pharmatech Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum plasma concentration (Cmax) of Sudapyridine	PK parameter	0,1,2,3,4,6,8,12,24,48,72,96,120,144 hours post-dose
Primary	Time to reach plasma Cmax (Tmax) of Sudapyridine	PK parameter	0,1,2,3,4,6,8,12,24,48,72,96,120,144 hours post-dose
Primary	Area under the plasma concentration-time curve (AUC) of Sudapyridine	PK parameter	0,1,2,3,4,6,8,12,24,48,72,96,120,144 hours post-dose
Primary	Terminal elimination half-life (t½) of Sudapyridine	PK parameter	0,1,2,3,4,6,8,12,24,48,72,96,120,144 hours post-dose
Primary	Volume of distribution (Vd/F) of Sudapyridine	PK parameter	0,1,2,3,4,6,8,12,24,48,72,96,120,144 hours post-dose
Primary	Apparent clearance (CL/F) of Sudapyridine	PK parameter	0,1,2,3,4,6,8,12,24,48,72,96,120,144 hours post-dose
Primary	Elimination rate constant Ke of Sudapyridine	PK parameter	0,1,2,3,4,6,8,12,24,48,72,96,120,144 hours post-dose
Primary	Number of participants with adverse events (AEs) or Serious Adverse Events (SAEs)	safety parameter	0,1,2,3,4,6,8,12,24,48,72,96,120,144 hours post-dose