A Phase I, Double-Blind, Randomized, Placebo-Controlled, Two-Period, Two-Cohort Crossover Study to Assess the Potential Interaction of Avanafil on the Pharmacokinetic and/or Hemodynamic Effects of Enalapril or Amlodipine in Male Subjects

VIVUS LLC1 site in 1 country48 target enrollmentApril 2010

ConditionsErectile Dysfunction

Interventionsavanafil and enalapril avanafil and amlodipine

Drugsavanafil and enalapril avanafil and amlodipine

Overview

Phase: Phase 1
Intervention: avanafil and enalapril
Conditions: Erectile Dysfunction
Sponsor: VIVUS LLC
Enrollment: 48
Locations: 1
Primary Endpoint: To measure the change in standing blood pressure after dosing
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to determine the change in the blood pressure and pulse rate, pharmacokinetics and the safety when avanafil is taken with either enalapril or amlodipine.

Registry

clinicaltrials.gov

Start Date

April 2010

End Date

May 2010

Last Updated

14 years ago

Study Type

Interventional

Study Design

Crossover

Sex

Male

Investigators

Sponsor

VIVUS LLC

Eligibility Criteria

Inclusion Criteria

•Voluntarily consent to participate in the study (informed consent form \[ICF\] must be signed and dated prior to any study related assessments).
•Adult male subjects of 40 to 65 years of age, inclusive.
•A body weight of at least 50 kg and a body mass index (BMI) between 18 and 32 kg/m2, inclusive \[BMI will be calculated as weight in kg/(height in m)2\].
•Subjects are able to communicate with the Investigator, and to understand and comply with all requirements of study participation.
•Medically healthy, with no clinically significant screening results (e.g., laboratory profiles, medical histories, ECGs, physical examinations, etc.), in the opinion of the Investigator.

Exclusion Criteria

•A history or presence of significant cardiovascular (including thromboembolic disorders), 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.
•A predisposition to priapism, such as subjects with sickle cell disease or blood dyscrasias.
•Known history of cardiovascular or cerebrovascular event, or any history of angina.
•History of fainting or vasovagal hypotension.
•History or ECG evidence of any high-risk arrhythmia or ECG judged by the Investigator to be clinically significant.
•Hypertrophic obstructive or other clinically significant cardiomyopathy, moderate or severe cardiac valvular disease.
•Subjects whose pulse is lower than 50 bpm at screening.
•Acute illness, especially any infection, within 2 weeks of dosing.
•Supine systolic blood pressure \</= 100 or \>/= 140 mmHg; supine diastolic blood pressure \</= 50 or \>/= 95 mmHg at screening (2 rechecks are allowed).

Arms & Interventions

enalapril and avanafil

Intervention: avanafil and enalapril

amlodipine and avanafil

Intervention: avanafil and amlodipine

Outcomes

Primary Outcomes

To measure the change in standing blood pressure after dosing

Time Frame: -0.5, -0.25, -0.17, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10 and 22 hours

Secondary Outcomes

To measure the pharmacokinetic parameters of taking avanafil with enalapril(before dosing and after dosing at the hours of 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12, 18, 24, 36, 48)
To measure the change in sitting and lying blood pressure and pulse rate after dosing(-0.5, -0.33, -0.17, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10 and 22 hours)
To determine the effects of enalapril on blood pressure and pulse rate(-0.5, -0.33, -0.17, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10 and 22 hours)
To measure the pharmacokinetic parameters of taking avanafil with amlodipine(before dosing and after dosing at the hours of 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12, 18, 24, 36, 48)
To determine the effects of amlodipine on blood pressure and pulse rate(-0.5, -0.33, -0.17, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10 and 22 hours)