Sudapyridine (WX-081) in Healthy Volunteers
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
1 other identifier
interventional
82
1 country
1
Brief Summary
The objective of this study is to evaluate the safety, tolerability as well as pharmacokinetics of Sudapyridine (WX-081) in Chinese volunteers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 healthy
Started Feb 2019
Longer than P75 for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 13, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 2, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 2, 2020
CompletedFirst Submitted
Initial submission to the registry
October 30, 2023
CompletedFirst Posted
Study publicly available on registry
November 7, 2023
CompletedNovember 7, 2023
October 1, 2023
1.4 years
October 30, 2023
November 2, 2023
Conditions
Outcome Measures
Primary Outcomes (8)
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
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
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
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
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
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
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
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
Study Arms (9)
Sudapyridine 30 mg single dose
EXPERIMENTALParticipants received Sudapyridine 30 mg single dose orally.
Sudapyridine 100 mg single dose
EXPERIMENTALParticipants received Sudapyridine 100 mg single dose orally.
Sudapyridine 200 mg single dose
EXPERIMENTALParticipants received Sudapyridine 200 mg single dose orally.
Sudapyridine 200 mg multiple doses
EXPERIMENTALParticipants received Sudapyridine 200 mg orally for multiple doses.
Sudapyridine 300 mg multiple doses
EXPERIMENTALParticipants received Sudapyridine 300 mg orally for multiple doses.
Placebo 100 mg single dose
PLACEBO COMPARATORParticipants received Placebo 100 mg single dose orally.
Placebo 200 mg single dose
PLACEBO COMPARATORParticipants received Placebo 200 mg single dose orally.
Placebo 200 mg multiple doses
PLACEBO COMPARATORarticipants received Placebo 200 mg orally for multiple doses.
Placebo 300mg multiple doses
PLACEBO COMPARATORParticipants received Placebo 300 mg orally for multiple doses.
Interventions
Sudapyridine capsule 30mg, orally, single dose
Sudapyridine tablet, 100mg orally, single dose
Sudapyridine tablet, 200mg orally, single dose
Sudapyridine tablet, 200mg orally once a day for 14 days
Sudapyridine tablet, 300mg orally once a day for 14 days
Placebo tablet, 100mg orally, single dose
Placebo tablet, 200mg orally once a day for 14 days
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shanghai Xuhui District Central Hospital
Shanghai, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yun Liu
Shanghai Xuhui District Central Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 30, 2023
First Posted
November 7, 2023
Study Start
February 13, 2019
Primary Completion
July 2, 2020
Study Completion
July 2, 2020
Last Updated
November 7, 2023
Record last verified: 2023-10
Data Sharing
- IPD Sharing
- Will not share