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The objective of this study is to assess the single dose pharmacokinetics of avanafil in subjects with hepatic impairment and in healthy control subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normal | Other | Subjects with normal hepatic function |
|
| Mild Hepatic Dysfunction | Other | Subjects with mild hepatic impairment |
|
| Moderate hepatic dysfunction | Other | Subjects with moderal hepatice impairment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| avanafil | Drug | 200 mg avanafil tablets QD |
|
| Measure | Description | Time Frame |
|---|---|---|
| Single Dose Pharmacokinetics of avanafil | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| single dose safety | 1 day |
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Inclusion Criteria:
Exclusion Criteria:
Main exclusion criteria for hepatically impaired subjects (Cohorts 2 and 3) include any significant concurrent medical condition or history of significant medical conditions other than hepatic impairment that may affect the interpretation of the data or which otherwise contraindicates participation in this study; acute exacerbation of or unstable hepatic disease, as indicated by worsening of clinical and/or laboratory signs of hepatic impairment, within the 2 weeks preceding study drug administration; history of esophageal variceal bleeding within past 6 months; history of bleeding or non-bleeding gastric varices; history of spontaneous bacterial peritonitis within the past 3 months; history of portosystemic surgical shunt; autoimmune liver disease; history of organ transplant; Wilson's disease; diagnosis of cholestatic liver disease (e.g., primary biliary cirrhosis or primary sclerosing cholangitis); history of recent symptomatic cryoglobulinemia; alcoholic hepatitis, determined clinically or by histology; initiation of any new prescription or over the counter medications within 14 days before study drug administration and hemoglobin < 9.0 g/dL, positive for AFP.
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| Name | Affiliation | Role |
|---|---|---|
| Shiyin Yee, PhD | VIVUS LLC | Study Director |
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| ID | Term |
|---|---|
| D007172 | Erectile Dysfunction |
| ID | Term |
|---|---|
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D012735 | Sexual Dysfunction, Physiological |
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| ID | Term |
|---|---|
| C553414 | avanafil |
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| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |