Healthy
Conditions
Brief summary
The objective of this study is to evaluate the safety, tolerability as well as pharmacokinetics of Sudapyridine (WX-081) in Chinese volunteers.
Detailed 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.
Interventions
DRUGSudapyridine 100mg SAD
Sudapyridine tablet, 100mg orally, single dose
DRUGSudapyridine 200mg SAD
Sudapyridine tablet, 200mg orally, single dose
DRUGSudapyridine 30mg
Sudapyridine capsule 30mg, orally, single dose
DRUGSudapyridine 200mg MAD
Sudapyridine tablet, 200mg orally once a day for 14 days
DRUGSudapyridine 300mg MAD
Sudapyridine tablet, 300mg orally once a day for 14 days
OTHERPlacebo tablet SAD
Placebo tablet, 100mg orally, single dose
OTHERPlacebo 200mg SAD
Placebo tablet, 200mg orally, single dose
OTHERPlacebo tablet MAD
Placebo tablet, 200mg orally once a day for 14 days
Sponsors
Shanghai Jiatan Pharmatech Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum plasma concentration (Cmax) of Sudapyridine | 0,1,2,3,4,6,8,12,24,48,72,96,120,144 hours post-dose | PK parameter |
| Time to reach plasma Cmax (Tmax) of Sudapyridine | 0,1,2,3,4,6,8,12,24,48,72,96,120,144 hours post-dose | PK parameter |
| Area under the plasma concentration-time curve (AUC) of Sudapyridine | 0,1,2,3,4,6,8,12,24,48,72,96,120,144 hours post-dose | PK parameter |
| Terminal elimination half-life (t½) of Sudapyridine | 0,1,2,3,4,6,8,12,24,48,72,96,120,144 hours post-dose | PK parameter |
| Volume of distribution (Vd/F) of Sudapyridine | 0,1,2,3,4,6,8,12,24,48,72,96,120,144 hours post-dose | PK parameter |
| Apparent clearance (CL/F) of Sudapyridine | 0,1,2,3,4,6,8,12,24,48,72,96,120,144 hours post-dose | PK parameter |
| Elimination rate constant Ke of Sudapyridine | 0,1,2,3,4,6,8,12,24,48,72,96,120,144 hours post-dose | PK parameter |
| Number of participants with adverse events (AEs) or Serious Adverse Events (SAEs) | 0,1,2,3,4,6,8,12,24,48,72,96,120,144 hours post-dose | safety parameter |
Countries
China
Outcome results
None listed