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| Name | Class |
|---|---|
| Celerion | INDUSTRY |
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The primary objective is to determine the single-dose pharmacokinetics (PK) of T-817 and T-817M5 (metabolite of T-817) in subjects with mild, moderate or severe hepatic impairment compared to matched healthy control subjects.
The secondary objective is to determine the safety and tolerability of single-dose T -817MA (Maleate salt of T-817) in subjects with mild, moderate or severe hepatic impairment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1:T-817MA | Experimental | Mild hepatic impairment subjects |
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| Cohort 2:T-817MA | Experimental | Healthy subjects matched to subjects in Cohort 1 |
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| Cohort 3:T-817MA | Experimental | Moderate hepatic impairment subjects |
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| Cohort 4:T-817MA | Experimental | Healthy subjects matched to subjects in Cohort 3 |
|
| Cohort 5 :T-817MA | Experimental | Severe hepatic impairment subjects |
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| Cohort 6:T-817MA | Experimental | Healthy subjects matched to subjects in Cohort 5 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| T-817MA | Drug | A single oral dose of 448 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Plasma concentrations | 8 days | |
| Area under the plasma concentration time curve (AUC) | 8 days | |
| Maximum observed plasma concentration (Cmax) | 8 days | |
| Time to reach the maximum observed plasma concentration (tmax) | 8 days | |
| Apparent terminal elimination rate constant | 8 days | |
| Apparent terminal elimination half-life (t½) | 8 days | |
| Apparent total plasma clearance of unbound drug after oral (extravascular) administration (CL/F) | 8 days | |
| Apparent volume of distribution during the terminal elimination phase after oral (extravascular) administration (Vd/F) | 8 days | |
| Metabolite to parent ratio (MPR) | 8 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-related adverse events | 8days |
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Inclusion Criteria:
For subjects with mild, moderate or severe hepatic impairment
For Matched Healthy Control Subjects Healthy adult male or female subjects will be matched 1:1 to a specific subject in the mild, moderate, or severe hepatic impairment cohort based upon age, weight, gender, and smoking status
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard Preston, M.D. | University of Miami | Principal Investigator |
| Thomas Marbury, M.D. | Orlando Clinical Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | Miami | Florida | United States | |||
| Orlando Clinical Research Center |
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| ID | Term |
|---|---|
| C503102 | 1-(3-(2-(1-benzothiophen-5-yl) ethoxy) propyl)-3-azetidinol maleate |
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| Orlando |
| Florida |
| United States |