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The purpose of this study is to investigate the pharmacokinetics and safety of a single dose of VX-770 in subjects with moderate hepatic impairment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | approximately 12 male and female subjects with moderate hepatic impairment |
|
| Group B | Experimental | approximately 12 healthy male and female subjects |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VX-770 | Drug | 150 mg oral tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| VX-770 pharmacokinetic parameters | 4 or 10 Days |
| Measure | Description | Time Frame |
|---|---|---|
| VX-770 metabolites pharmacokinetic parameters | 4 or 10 days | |
| Safety as measured by adverse events, clinical laboratory values, standard electrocardiograms (ECGs), and vital signs | up to 40 days |
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Inclusion Criteria:
Group A (Subjects with Hepatic Impairment):
Group B (Healthy Subjects):
Exclusion Criteria:
Group A (Subjects with Hepatic Impairment):
Group B (Healthy Subjects):
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hradec Králové | Czechia | |||||
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| ID | Term |
|---|---|
| C545203 | ivacaftor |
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| Prague |
| Czechia |
| Bratislava | Slovakia |