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The purpose of this study is to assess the effects of hepatic impairment on the multiple dose pharmacokinetics of BMS-650032.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BMS-650032 in Child-Pugh A | Active Comparator |
| |
| BMS-650032 in Child-Pugh B | Active Comparator |
| |
| BMS-650032 in Child-Pugh C | Active Comparator |
| |
| BMS-650032 in Healthy Subjects | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-650032 | Drug | Capsules, Oral, 200 mg, BID, 7 Days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics parameters including Cmax, Tmax,AUC(TAU),Vss/F, T-Half, CLT/F and AI | Day 10 |
| Measure | Description | Time Frame |
|---|---|---|
| Assess the safety and tolerability of BMS-650032 in subjects with hepatic impairment and in healthy subjects. This will be measured by: blood chemistries, hematology, urinalysis and ECGs | Day 10 | |
| Assess the relationship between the Child-Pugh classification (including its components) and BMS-650032 PK parameters. This will be measured by frequent pharmacokinetics blood samples. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Advanced Clinical Res Inst | Anaheim | California | 92801 | United States | ||
| Orlando Clinical Research Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24704773 | Derived | Eley T, He B, Chang I, Colston E, Child M, Bedford W, Kandoussi H, Pasquinelli C, Marbury TC, Bertz RJ. The effect of hepatic impairment on the pharmacokinetics of asunaprevir, an HCV NS3 protease inhibitor. Antivir Ther. 2015;20(1):29-37. doi: 10.3851/IMP2773. Epub 2014 Apr 7. |
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| ID | Term |
|---|---|
| D048550 | Hepatic Insufficiency |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C571889 | asunaprevir |
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| Day 10 |
| Orlando |
| Florida |
| 32809 |
| United States |