Overview

To Evaluate The Effect Of Ketoconazole, Ritonavir and Erythromycin on the Safety and Pharmacokinetics of Avanafil

Status:
Completed
Trial end date:
2008-12-01
Target enrollment:
0
Participant gender:
Male
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 are potent inhibitors of CYP3A4 and erythromycin is a moderate CYP3A4 inhibitor. Any interaction that is observed would be predictive of other inhibitors of CYP3A4.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
VIVUS, Inc.
Treatments:
Erythromycin
Erythromycin Estolate
Erythromycin Ethylsuccinate
Erythromycin stearate
Ketoconazole
Ritonavir
Criteria
Inclusion Criteria:

1. Males, 21 to 45 years of age (inclusive).

2. A body weight of at least 50 kg and a body mass index (BMI) between 21 and 28 kg/m2,
inclusive

3. Medically healthy, with clinically insignificant screening results [e.g., laboratory
profiles, medical histories, ECGs, physical exam, etc., in the opinion of the
investigator.

4. Subjects are able to communicate with the investigator, and to understand and comply
with all requirements of study participation.

5. Voluntarily consent to participate in the study

6. The subject must agree not to donate his sperm during and within 3-months of the
completion of the study.

7. All sexually active male subjects and their female partners of childbearing potential
must agree to use adequate contraception methods, for the specified time.

Exclusion Criteria:

1. 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.

2. Any clinically significant laboratory abnormalities as judged by the investigator.

3. 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.

4. Positive urine drug test and/or positive breath alcohol test.

5. Positive testing for human immunodeficiency virus (HIV), hepatitis B surface antigen
(HBsAg), or hepatitis C antibodies (HCV) at screening.

6. Any history or presence of alcoholism or drug or substance abuse.

7. Allergy to or previous adverse events with PDE5 inhibitors, ketoconazole, ritonavir
and/or erythromycin or their constituents.

8. Use of any prescription or over-the-counter (OTC) medication, including herbal
products.

9. Use of any drugs known to have clinical significance in inhibiting or inducing liver
enzymes involved in drug metabolism

10. Blood donation or significant blood loss.

11. Any use of tobacco or nicotine products within 6 months.

12. Any history of celiac diseases, food allergies, and those on vegetarian or other diets
incompatible with study objectives.

13. Any subject who received an investigational drug within 30 days .

14. Clinical judgment by the investigator that the subject should not participate in the
study.