Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The objective of this study is to evaluate the safety, tolerability as well as pharmacokinetics of Sudapyridine (WX-081) in Chinese volunteers.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sudapyridine 30 mg single dose | Experimental | Participants received Sudapyridine 30 mg single dose orally. |
|
| Sudapyridine 100 mg single dose | Experimental | Participants received Sudapyridine 100 mg single dose orally. |
|
| Sudapyridine 200 mg single dose | Experimental | Participants received Sudapyridine 200 mg single dose orally. |
|
| Sudapyridine 200 mg multiple doses | Experimental | Participants received Sudapyridine 200 mg orally for multiple doses. |
|
| Sudapyridine 300 mg multiple doses | Experimental | Participants received Sudapyridine 300 mg orally for multiple doses. |
|
| Placebo 100 mg single dose | Placebo Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sudapyridine 30mg | Drug | Sudapyridine capsule 30mg, orally, single dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Yun Liu | Shanghai Xuhui District Central Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Xuhui District Central Hospital | Shanghai | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| C000723535 | sudapyridine |
| D064346 | Sagittal Abdominal Diameter |
| C110804 | mycophenolic adenine dinucleotide |
| ID | Term |
|---|---|
| D049628 | Body Size |
| D001837 | Body Weights and Measures |
| D001824 | Body Constitution |
| D010808 | Physical Examination |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Participants received Placebo 100 mg single dose orally.
|
| Placebo 200 mg single dose | Placebo Comparator | Participants received Placebo 200 mg single dose orally. |
|
| Placebo 200 mg multiple doses | Placebo Comparator | articipants received Placebo 200 mg orally for multiple doses. |
|
| Placebo 300mg multiple doses | Placebo Comparator | Participants received Placebo 300 mg orally for multiple doses. |
|
| Sudapyridine 100mg SAD | Drug | Sudapyridine tablet, 100mg orally, single dose |
|
|
| Sudapyridine 200mg SAD | Drug | Sudapyridine tablet, 200mg orally, single dose |
|
|
| Sudapyridine 200mg MAD | Drug | Sudapyridine tablet, 200mg orally once a day for 14 days |
|
|
| Sudapyridine 300mg MAD | Drug | Sudapyridine tablet, 300mg orally once a day for 14 days |
|
|
| Placebo tablet SAD | Other | Placebo tablet, 100mg orally, single dose |
|
|
| Placebo 200mg SAD | Other | Placebo tablet, 200mg orally, single dose |
|
| Placebo tablet MAD | Other | Placebo tablet, 200mg orally once a day for 14 days |
|
|
| Placebo tablet MAD | Other | Placebo tablet, 300mg orally once a day for 14 days |
|
|
| 0,1,2,3,4,6,8,12,24,48,72,96,120,144 hours post-dose |
| D019937 |
| Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D000886 | Anthropometry |
| D008919 | Investigative Techniques |
| D010829 | Physiological Phenomena |