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Study of [14C]CS0159 in China Healthy Subjects.
A phase I study to quantify the total mass balance in healthy subjects after a single dose of [14C]CS0159.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [14C]CS0159 | Experimental | Single oral dose of 4mg [14C]CS0159 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [14C]CS0159 | Drug | Single oral administration of 4mg [14C]CS0159 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mass Balance | Mass balance recovery of total radioactivity in urine and fecal samples. | Screening period (-48 hours) to 240 hours |
| [14C] CS0159 metabolite | Identification of the major metabolites of CS0159 in human plasma, urine and faeces, determine the main Determine the main biotransformation pathways and calculate the percentage of the administered dose of the prodrug and each metabolite in urine and faeces, and plasma prodrugs and circulating metabolites as a percentage of total exposure AUC. | Screening period (-48 hours) to 240 hours |
| Radioactivity of CS0159 | Whole blood to plasma total radioactivity ratio | Up to 90 hours post dose |
| Area under the curve | Total radioactivity in plasma PK: AUC | Up to 90 hours post dose |
| Highest radioactivity observed plasma concentration | Total radioactivity in plasma PK: Cmax | Up to 90 hours post dose |
| Time for Cmax | Total radioactivity in plasma PK: Tmax | Up to 90 hours post dose |
| Elimination half-life | Total radioactivity in plasma PK: T1/2 | Up to 90 hours post dose |
| Measure | Description | Time Frame |
|---|---|---|
| Blood plasma PK | other major metabolites in plasma( if any). | Up to 90 hours post dose |
| Adverse events | All subjects will be assessed for incidence and severity of adverse events (AEs) and serious AEs |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Deng Rong | Cascade Pharmaceuticals, Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Soochow University | Suzhou | Jiangsu | 215006 | China |
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| ID | Term |
|---|---|
| D008105 | Liver Cirrhosis, Biliary |
| ID | Term |
|---|---|
| D002780 | Cholestasis, Intrahepatic |
| D002779 | Cholestasis |
| D001649 | Bile Duct Diseases |
| D001660 | Biliary Tract Diseases |
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| Up to 240 hours post dose |
| AUC of CS0159 | Area under the plasma concentration time curve of CS0159 | Up to 90 hours post dose |
| Cmax of CS0159 | Highest observed plasma concentration of CS0159 | Up to 90 hours post dose |
| T1/2 of CS0159 | Elimination half-life of CS0159 | Up to 90 hours post dose |
| Tmax of CS0159 | Time for Cmax of CS0159 | Up to 90 hours post dose |
| D004066 |
| Digestive System Diseases |
| D008107 | Liver Diseases |
| D008103 | Liver Cirrhosis |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |