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
This Phase 1 open label study is being conducted to directly characterize the pharmacokinetic (PK) profiles of Chiglitazar following administration of a single oral dose in subjects with varying degrees of hepatic impairment compared to subjects with normal hepatic function.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normal Hepatic Function | Experimental | Subjects with normal hepatic function will receive a single 48 mg oral dose of Chiglitazar |
|
| Mild Hepatic Impairment | Experimental | Subjects with mild hepatic impairment will receive a single 48 mg oral dose of Chiglitazar |
|
| Moderate Hepatic Impairment | Experimental | Subjects with moderate hepatic impairment will receive a single 48 mg oral dose of Chiglitazar |
|
| Severe Hepatic Impairment | Experimental | Subjects with severe hepatic impairment will receive a single 48 mg oral dose of Chiglitazar |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chiglitazar | Drug | Oral single dose 48 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Maximum plasma concentration | 4 days |
| AUC0-t and AUC0-inf | Area under of the curve (AUC0-t and AUC0-inf) | 4 days |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Supplementary exclusion criteria for subjects with hepatic impairment:
Supplementary exclusion criteria for subjects with normal hepatic function:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| LiYan Miao | First Affiliated Hospital of Suzhou Medical College | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the First Affiliated Hospital of Soochow University | Suzhou | Jiangsu | China |
Not provided
| ID | Term |
|---|---|
| C515629 | chiglitazar |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided