To Assess the Safety of Avanafil in Healthy and Hepatically Impaired Male Subjects.

Erectile Dysfunction Clinical Trial

— avanafil  

Official title:

A PHASE I, OPEN LABEL, NON-RANDOMIZED, SINGLE-DOSE, PARALLEL-COHORT, MATCHED-CONTROL STUDY TO EVALUATE THE PHARMACOKINETICS AND SAFETY OF AVANAFIL (TA-1790) IN SUBJECTS WITH HEPATIC IMPAIRMENT AND IN HEALTHY CONTROL MALE SUBJECTS

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01054430
• Other study ID #: TA-012
• Status: Completed
• Phase: Phase 1
• First received: January 20, 2010
• Last updated: January 5, 2011
• Start date: January 2010
• Est. completion date: February 2010

Study information

• Verified date: January 2011
• Source: VIVUS, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to assess the single dose pharmacokinetics of avanafil in subjects with hepatic impairment and in healthy control subjects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 21 Years to 75 Years

Eligibility

Inclusion Criteria:

• Male subjects must be 21-75 years of age; inclusive. Healthy control subjects (Cohort 1) must be medically healthy with clinically insignificant screening results and hepatically impaired subjects (Cohorts 2 and 3) must have mild or moderate hepatic impairment based on the Child-Pugh Classification.

Exclusion Criteria:

• Main exclusion criteria for healthy control subjects (Cohort 1) include history or clinical evidence of clinically relevant cardiovascular (including thromboembolic disorders), hepatic, renal, hematologic, endocrine, pulmonary, gastrointestinal, psychiatric or neurological impairment; any clinically significant laboratory abnormalities as judged by the investigatorInvestigator; systolic blood pressure < 90 or >160 mmHg; diastolic blood pressure < 50 or > 90 mmHg; allergy to or previous adverse events with PDE5 inhibitors; use of prescription or over-the-counter drugs that are known to interfere with metabolism by the cytochrome P450 3A4 enzyme within 30 days of screening; use of any investigational drug within 30 days of screening; use of any prescription or over-the-counter drugs or herbal remedies within 14 days of screening; history of alcohol or drug abuse within 18 months, history of smoking within 6 months; positive breath alcohol test; positive serology for HIV, HCV, HBsAg; blood donation or significant blood loss within 56 days of dosing; plasma donation within 7 days of dosing.

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Erectile Dysfunction

Intervention

Drug:
• avanafil
200 mg avanafil tablets QD

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
VIVUS, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Single Dose Pharmacokinetics of avanafil		1 day	No
Secondary	single dose safety		1 day	No