Hemodynamic Study of Avanafil and Two α-Adrenergic Blockers,Doxazosin and Tamsulosin

NCT01100021 | Completed Phase 1

• 1 other identifier: TA-017
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to see if avanafil causes any changes in blood pressure and pulse rate when taken with doxazosin or tamsulosin.

Conditions

Erectile Dysfunction

Outcome Measures

Primary Outcomes (1)

• The maximum decrease in blood pressure after dosing

  30, 20, 10 min predose; 15, 30, 45, 60, 75, 90, 105, 120 min, 2.5, 3, 3.5, 4, 5, 6, 7, 10, 12, 18, and 24 hrs postdose

Secondary Outcomes (1)

• The maximum decrease in blood pressure and pulse rate after dosing

  30, 20, 10 min predose; 15, 30, 45, 60, 75, 90, 105, 120 min, 2.5, 3, 3.5, 4, 5, 6, 7, 10, 12, 18, and 24 hrs postdose

Study Arms (2)

tamsulosin + avanafil

EXPERIMENTAL

Drug: Tamsulosin and avanafil

Doxazosin + avanafil

EXPERIMENTAL

Drug: Doxazosin and avanafil

Interventions

Tamsulosin and avanafil DRUG

tamsulosin - 0.4mg daily for 18 days; avanafil - 200 mg 1 x 2 days

tamsulosin + avanafil

Doxazosin and avanafil DRUG

doxazosin - 1 mg 1 x 1 day; 2 mg 1 x 2 days; 4 mg 1 x 4 days; 8 mg 1 x 11 days; avanafil - 200 mg 1 x 1 day

Doxazosin + 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:

• Written Informed Consent.
• Adult male subjects 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 exam, etc.), in the opinion of the Investigator in consultation with the Sponsor.
• Male subjects should be willing to use a condom and spermicide during sexual activity for 90 days after last dosing of avanafil and be willing to not donate sperm for 90 days after dosing.

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.
• A predisposition to priapism, such as subjects with sickle cell disease or blood dyscrasias.
• Known history of cardiovascular or cerebrovascular event, any history of angina.
• Subjects with episode(s) 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 55 bpm at screening or 50 bpm prior to dosing.
• Acute illness, especially any infection, within 2 weeks of dosing.
• Systolic blood pressure \< 90 or \>150 mmHg; diastolic blood pressure \< 50 or \> 95 mmHg at screening or at check-in on Day -1 (2 rechecks are allowed).
• Subjects with benign prostatic hyperplasia or orthostatic hypotension (as evidenced by reduction of 20 mmHg or more in systolic blood pressure, reduction of 10 mmHg or more in diastolic blood pressure, or evidence of cerebral hypoperfusion upon standing from a seated position).
• History of retinitis pigmentosa or nonarteritic anterior ischemic optic neuropathy.
• Any history of bipolar disorder or psychosis, history of psychiatric hospitalization, greater than one lifetime episode of major depression.
• Hemoglobin \< 12.0 g/dL.
• Subjects with liver function tests \> 1.5 ULN
• Positive urine drug test and/or positive urine alcohol test at screening or at check-in on Day -1.

Sponsors & Collaborators

• VIVUS LLC: lead

Study Sites (1)

MDS Pharma Services Inc.,

Tempe, Arizona, 85283, United States

Location

MeSH Terms

Conditions

Erectile Dysfunction

Interventions

Tamsulosin; avanafil; Doxazosin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Prazosin; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Scott Sharples, MD

  MDS Pharma Services, Inc

  PRINCIPAL INVESTIGATOR

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: January 20, 2010
• First Posted: April 8, 2010
• Study Start: February 1, 2010
• Primary Completion: March 1, 2010
• Study Completion: April 1, 2010
• Last Updated: January 7, 2011

Record last verified: 2011-01

Locations

US (1)