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

This study has been completed.
Sponsor:
Information provided by:
VIVUS, Inc.
ClinicalTrials.gov Identifier:
NCT01054430
First received: January 20, 2010
Last updated: January 5, 2011
Last verified: January 2011
  Purpose

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


Condition Intervention Phase
Erectile Dysfunction
Drug: avanafil
Phase 1

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

Resource links provided by NLM:


Further study details as provided by VIVUS, Inc.:

Primary Outcome Measures:
  • Single Dose Pharmacokinetics of avanafil [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • single dose safety [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Enrollment: 27
Study Start Date: January 2010
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Normal
Subjects with normal hepatic function
Drug: avanafil
200 mg avanafil tablets QD
Mild Hepatic Dysfunction
Subjects with mild hepatic impairment
Drug: avanafil
200 mg avanafil tablets QD
Moderate hepatic dysfunction
Subjects with moderal hepatice impairment
Drug: avanafil
200 mg avanafil tablets QD

  Eligibility

Ages Eligible for Study:   21 Years to 75 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01054430

Sponsors and Collaborators
VIVUS, Inc.
Investigators
Study Director: Shiyin Yee, PhD VIVUS, Inc.
  More Information

No publications provided

Responsible Party: Wesley Day, VP Clinical, Vivus, Inc.
ClinicalTrials.gov Identifier: NCT01054430     History of Changes
Other Study ID Numbers: TA-012
Study First Received: January 20, 2010
Last Updated: January 5, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by VIVUS, Inc.:
Avanafil
Hepatic
Erectile Dysfunction
Impairment

Additional relevant MeSH terms:
Erectile Dysfunction
Genital Diseases, Male
Mental Disorders
Sexual and Gender Disorders
Sexual Dysfunction, Physiological
Sexual Dysfunctions, Psychological

ClinicalTrials.gov processed this record on October 21, 2014