CompletedPhase 1

Drug Interaction Study of Avanafil and Enalapril or Amlodipine

United States48 participantsStarted 2010-04

Plain-language 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.

Who can participate

Age range

40 Years – 65 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

To measure the change in standing blood pressure after dosing

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

Trial details

NCT IDNCT01117038

SponsorVIVUS LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2010-05

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