Status:
COMPLETED
To Evaluate The Effect Of Ketoconazole, Ritonavir and Erythromycin on the Safety and Pharmacokinetics of Avanafil
Lead Sponsor:
VIVUS LLC
Conditions:
Erectile Dysfunction
Eligibility:
MALE
21-45 years
Phase:
PHASE1
Brief Summary
This study is being conducted to examine the effect of three CYP3A4 inhibitors (ketoconazole, erythromycin and ritonavir) on the single dose pharmacokinetics of avanafil. Ketoconazole and ritonavir ar...
Detailed Description
Rationale: Erectile dysfunction (ED) is the persistent or recurrent inability to attain and maintain penile erection sufficient to permit satisfactory sexual performance. The current first-line treat...
Eligibility Criteria
Inclusion
- Males, 21 to 45 years of age (inclusive).
- A body weight of at least 50 kg and a body mass index (BMI) between 21 and 28 kg/m2, inclusive
- Medically healthy, with clinically insignificant screening results \[e.g., laboratory profiles, medical histories, ECGs, physical exam, etc., in the opinion of the investigator.
- Subjects are able to communicate with the investigator, and to understand and comply with all requirements of study participation.
- Voluntarily consent to participate in the study
- The subject must agree not to donate his sperm during and within 3-months of the completion of the study.
- All sexually active male subjects and their female partners of childbearing potential must agree to use adequate contraception methods, for the specified time.
Exclusion
- A history or presence of significant cardiovascular, neurological, hematological, psychiatric, hepatic, gastrointestinal, pulmonary, endocrine, immunologic or renal disease or other condition known to interfere with the absorption, distribution, metabolism, or excretion of drugs or place the subjects at increased risk as determined by the investigator.
- Any clinically significant laboratory abnormalities as judged by the investigator.
- Systolic blood pressure \< 90 or \>140 mmHg; diastolic blood pressure \< 50 or \> 90 mmHg at screening or at check-in on day 1 in treatment period 1.
- Positive urine drug test and/or positive breath alcohol test.
- Positive testing for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C antibodies (HCV) at screening.
- Any history or presence of alcoholism or drug or substance abuse.
- Allergy to or previous adverse events with PDE5 inhibitors, ketoconazole, ritonavir and/or erythromycin or their constituents.
- Use of any prescription or over-the-counter (OTC) medication, including herbal products.
- Use of any drugs known to have clinical significance in inhibiting or inducing liver enzymes involved in drug metabolism
- Blood donation or significant blood loss.
- Any use of tobacco or nicotine products within 6 months.
- Any history of celiac diseases, food allergies, and those on vegetarian or other diets incompatible with study objectives.
- Any subject who received an investigational drug within 30 days .
- Clinical judgment by the investigator that the subject should not participate in the study.
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT00770042
Start Date
October 1 2008
End Date
December 1 2008
Last Update
December 2 2009
Active Locations (1)
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1
Research Site
Lincoln, Nebraska, United States, 68502