Assess the Effect of Food on Avanafil Pharmacokinetic (PK), to Compare 2 Oral Formulations of Avanafil,and Investigate Dose Proportionality in Healthy Male Subjects

NCT01095601 | Completed Phase 1

• 1 other identifier: TA-020
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study will assess the effect of food on the pharmacokinetics of avanafil (Formulation II); determine the relative bioavailability of two avanafil tablet formulations (Formulation I versus Formulation II) and will investigate the dose-proportionality of Formulation II avanafil tablet.

Conditions

Healthy

Keywords

avanafil; absoprion; bioavailability; food effect; dose-proportionality; TA-1790; Pharmacokinetics of avanafil

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetics of avanafil

  Cmax and AUC of avanafil in each period

  April through May 2010

Secondary Outcomes (1)

• Safety/AEs of avanafil

  April through May, 2010

Study Arms (4)

Treatment A

OTHER

2x100 mg Formulation II avanafil tablet, fasted

Drug: Avanafil

Treatment B

OTHER

2x100 mg Formulation II avanafil tablet, fed

Drug: Avanafil

Treatment C

OTHER

2x100 mg Formulation I avanafil tablet, fasted

Drug: Avanafil

Treatment D

OTHER

1x50 mg Formulation II avanafil tablet, fasted

Drug: Avanafil

Interventions

Avanafil DRUG

* Treatment A: 2x100 mg Formulation II avanafil tablet, fasted * Treatment B: 2x100 mg Formulation II avanafil tablet, fed * Treatment C: 2x100 mg Formulation I avanafil tablet, fasted * Treatment D: 1x50 mg Formulation II avanafil tablet, fasted

Also known as: TA-1790

Treatment A; Treatment B; Treatment C; Treatment D

Eligibility Criteria

• Age: 18 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 \>150 mmHg;
• diastolic blood pressure \< 50 or \> 95 mmHg;
• history of retinitis pigmentosa or nonarteritic anterior ischemic optic neuropathy; allergy to or previous adverse events with PDE5 inhibitors 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 prior to Day 1 in Period 1;
• use of any investigational drug within 30 days or six half-lives, whichever is longer, prior to Day 1 in Period 1;
• use of any prescription or over-the-counter drugs or herbal remedies within 14 days prior to Day 1 in Period 1;
• history of alcohol or drug abuse within 18 months, history of smoking within 6 months;
• positive urine alcohol test;
• positive cotinine test, positive urine drug screen;
• positive serology for HIV, HCV antibody, HBsAg.

Sponsors & Collaborators

• VIVUS LLC: lead

MeSH Terms

Interventions

avanafil

Study Officials

• Shiyin Yee

  VIVUS LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 28, 2010
• 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