Study the Effect of Avanafil on the Pharmacodynamics and Pharmacokinetics of Warfarin in Healthy Male Subjects

NCT01095588 | Completed Phase 1

• 1 other identifier: TA-016
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is designed to look into the effect of avanafil on blood levels of warfarin and to investigate its effect on prothrombin time/international normalized ratio (INR) in healthy men.

Conditions

Erectile Dysfunction

Keywords

ED

Outcome Measures

Primary Outcomes (2)

• Pharmacokinetics - PK parameters AUC, C-max and t-max of R-and S-warfarin

  24 hrs

• Pharmacodynamics - Prothrombin time, INR values, and area under effect-time curve (AUEC) of prothrombin and INR on days 14 and 15

  24 hours

Study Arms (2)

Avanafil

EXPERIMENTAL

Drug: 200 mg Avanafil

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

200 mg Avanafil DRUG

2 X 100mg tablets avanafil

Avanafil

Placebo DRUG

2 tablets

Placebo

Eligibility Criteria

• Age: 21 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• adult male subjects,
• to 45 years of age,
• must be medically healthy with no clinically significant screening results.

You may not qualify if:

• history or clinical evidence of clinically relevant cardiovascular (including thromboembolic disorders), hepatic, renal, hematological, endocrine, pulmonary, gastrointestinal, psychiatric or neurological impairment;
• any clinically significant laboratory abnormalities as judged by the investigator;
• systolic blood pressure \< 90 or \>120 mmHg;
• diastolic blood pressure \< 50 or \> 90 mmHg;
• allergy to or previous adverse events with PDE5 inhibitors, warfarin or their constituents;
• use of prescription or over-the-counter drugs that are known to interfere with metabolism by the cytochrome P450 3A4 enzyme within 30 days of screening;
• use of any investigational drug within 30 days of screening; use of any prescription or over-the-counter drugs or herbal remedies within 14 days of screening;
• history of alcohol or drug abuse within 18 months, history of smoking within 6 months;
• positive urine alcohol and drug test;
• positive serum cotinine test;
• positive serology for HIV, HCV, HBsAg.

Sponsors & Collaborators

• VIVUS LLC: lead

MeSH Terms

Conditions

Erectile Dysfunction

Interventions

avanafil

Condition Hierarchy (Ancestors)

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

Study Officials

• Shiyin Yee, PhD

  VIVUS LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 6, 2009
• First Posted: March 30, 2010
• Study Start: April 1, 2010
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: January 7, 2011

Record last verified: 2011-01