Erectile DysfunctionPhase 1NCT01117038
Drug Interaction Study of Avanafil and Enalapril or Amlodipine
A Phase 1 study testing avanafil and enalapril and avanafil and amlodipine in people with Erectile Dysfunction, run by VIVUS LLC at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Erectile Dysfunction
- What is being tested?
- avanafil and enalapril and avanafil and amlodipine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to May 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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).
- Subjects with orthostatic hypotension (as evidenced by a reduction of 30 mmHg or more in systolic blood pressure, reduction of 20 mmHg or more in diastolic blood pressure, or evidence of cerebral hypoperfusion upon standing from a seated position).
- Any history of bipolar disorder or psychosis, history of psychiatric hospitalization, greater than one lifetime episode of major depression.
- Hemoglobin < 12.0 g/dL.
- Positive urine drug test, positive urine alcohol test, or positive urine cotinine test at screening or at check-in on Day -1.
- 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 within 18 months or as defined by the Investigator.
- Allergy to or previous adverse events with PDE5 inhibitors, ACE inhibitors, calcium channel blockers, or their constituents.
- Use of any prescription or over-the-counter (OTC) medication, including herbal products, within the 14 days prior to Day 1 and throughout the study. Up to 2 g per day of acetaminophen is allowed at the discretion of the Investigator.
- Use of any drug in Appendix 1 (drugs known to interfere with metabolism by the CYP450 3A4 enzyme) within 30 days prior to Day 1.
- Blood donation or significant blood loss within 56 days prior to Day 1.
- Plasma donation within 14 days prior to Day 1.
- Any use of tobacco or nicotine products within 6 months prior to Day 1.
- Any subject who received an investigational drug within 30 days or six half-lives, whichever is longer, prior to Day 1.
- Involvement in the planning and conduct of the study (applies to both VIVUS or designee staff, or staff at the investigational site).
- Previously participated in a trial with avanafil.
- Subjects who report having difficulty swallowing tablets, capsules, etc.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
- Conditions
- Erectile Dysfunction
- Being tested
- avanafil and enalapril, avanafil and amlodipine
- Keywords
- ED, Erectile Dysfunction
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
avanafil and enalaprilDrug
enalapril twice a day for 11 days avanafil/placebo once a day for 2 days
avanafil and amlodipineDrug
amlodipine 5mg once a day for 16 days avanafil/placebo once a day for 3 days
| Study group | Role | What they receive |
|---|---|---|
| enalapril and avanafil | Experimental | Not described Receives: Drug: avanafil and enalapril |
| amlodipine and avanafil | Experimental | Not described Receives: Drug: avanafil and amlodipine |
What is being measured
The primary outcome is the main question the study is designed to answer.
To measure the change in standing blood pressure after dosing
Measured: -0.5, -0.25, -0.17, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10 and 22 hours
Secondary outcomes (5)
To measure the pharmacokinetic parameters of taking avanafil with enalapril
AUCc-tau Cmax Cmin Tmax AUC0-t AUC0-inf t1/2 Kel
Measured: 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
Measured: -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
Measured: -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
AUCc-tau Cmax Cmin Tmax AUC0-t AUC0-inf t1/2 Kel
Measured: 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
Measured: -0.5, -0.33, -0.17, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10 and 22 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2010 (estimated)
- Study startApr 2010
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erectile DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- VIVUS LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Shiyin Yee, PhD, Study director, VIVUS LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01117038
- Sponsor's protocol ID
- TA-019
- Status last verified
- Aug 2011
- First submitted
- 23 Apr 2010
- Last updated
- 10 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01117038
- Acronym / sponsor ID
- TA-019
- Conditions
- Erectile Dysfunction
- Keywords
- ED, Erectile Dysfunction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- VIVUS LLCIndustry (pharma, biotech, devices)
- Study start
- Apr 2010
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 5 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| enalapril and avanafil | Experimental | Drug: avanafil and enalapril |
| amlodipine and avanafil | Experimental | Drug: avanafil and amlodipine |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (26 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| avanafil and enalaprilenalapril twice a day for 11 days avanafil/placebo once a day for 2 days | Drug | enalapril and avanafil |
| avanafil and amlodipineamlodipine 5mg once a day for 16 days avanafil/placebo once a day for 3 days | Drug | amlodipine and avanafil |
Primary outcome
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
5 secondary outcomes
To measure the pharmacokinetic parameters of taking avanafil with enalapril
Time frame: 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
Time frame: -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
Time frame: -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
Time frame: 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
Time frame: -0.5, -0.33, -0.17, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10 and 22 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shiyin Yee, PhD study director
VIVUS LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing avanafil and enalapril and avanafil and amlodipine in people with Erectile Dysfunction, run by VIVUS LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2011.