Drug Interaction Study of Avanafil and Enalapril or Amlodipine

NCT01117038 | Completed Phase 1

• 1 other identifier: TA-019
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Erectile Dysfunction

Keywords

ED; Erectile Dysfunction

Outcome Measures

Primary Outcomes (1)

• To measure the change in standing blood pressure after dosing

  -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

  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

Study Arms (2)

enalapril and avanafil

EXPERIMENTAL

Drug: avanafil and enalapril

amlodipine and avanafil

EXPERIMENTAL

Drug: avanafil and amlodipine

Interventions

avanafil and enalapril DRUG

enalapril twice a day for 11 days avanafil/placebo once a day for 2 days

enalapril and avanafil

avanafil and amlodipine DRUG

amlodipine 5mg once a day for 16 days avanafil/placebo once a day for 3 days

amlodipine and avanafil

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• VIVUS LLC: lead

Study Sites (1)

Celerion

Tempe, Arizona, 85283, United States

Location

MeSH Terms

Conditions

Erectile Dysfunction

Interventions

avanafil; Enalapril; Amlodipine

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Intervention Hierarchy (Ancestors)

Dipeptides; Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins; Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Shiyin Yee, PhD

  VIVUS LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 23, 2010
• First Posted: May 5, 2010
• Study Start: April 1, 2010
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: August 10, 2011

Record last verified: 2011-08

Locations

US (1)