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

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ClinicalTrials.gov Identifier: NCT01095601
Recruitment Status : Completed
First Posted : March 30, 2010
Last Update Posted : January 7, 2011
Sponsor:
Information provided by:
VIVUS, Inc.

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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Avanafil Phase 1

Detailed Description:

In this Phase I, single-centre, open-label, randomized, four-period crossover study, each eligible subject will be randomized to receive the 4 treatments in a 4-way crossover fashion. The 4 treatments are as follows:

  • 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 Subjects will report to the study site on the evening before each treatment and will remain at the site until the 24-hour PK sample has been drawn. A single oral dose of avanafil tablets will be administered with 240 mL of water. A washout period of at least 5 days will occur between the treatments. Subjects in treatment groups A, C and D will fast at least 10 hours prior to and for at least 4 hours following dosing. Subjects in treatment group B will eat a standardized high fat breakfast 30 prior to dosing. Standard meals will be provided uniformly to all subjects at approximately 4 and 9 hours after dosing, and an evening snack will be provided approximately 12 - 13 hours after dosing. Blood samples for the determination of plasma avanafil and its metabolite concentrations will be obtained from each subject at 0 (30 minutes pre-dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 8, 12, 18 and 24 hours post-dose in each treatment period.

Adverse events; laboratory evaluations; color vision testing (Treatment A only), electrocardiogram and physical examination, vital signs will be assessed at various times during the study.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Phase I, Single-Centre, Open-Label, Randomized, Four-Period Crossover Study to Assess the Effect of Food on the Pharmacokinetics of Avanafil, to Determine The Relative Bioavailability of Two Avanafil Tablet Formulations and to Investigate Dose Proportionality in Healthy Male Subjects
Study Start Date : April 2010
Actual Primary Completion Date : May 2010
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Avanafil

Arm Intervention/treatment
Treatment A
2x100 mg Formulation II avanafil tablet, fasted
Drug: Avanafil
  • 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
Other Name: TA-1790

Treatment B
2x100 mg Formulation II avanafil tablet, fed
Drug: Avanafil
  • 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
Other Name: TA-1790

Treatment C
2x100 mg Formulation I avanafil tablet, fasted
Drug: Avanafil
  • 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
Other Name: TA-1790

Treatment D
1x50 mg Formulation II avanafil tablet, fasted
Drug: Avanafil
  • 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
Other Name: TA-1790




Primary Outcome Measures :
  1. Pharmacokinetics of avanafil [ Time Frame: April through May 2010 ]
    Cmax and AUC of avanafil in each period


Secondary Outcome Measures :
  1. Safety/AEs of avanafil [ Time Frame: April through May, 2010 ]
    Adverse events; laboratory evaluations; color vision testing (Treatment A only), electrocardiogram and physical examination, vital signs will be assessed at various times during the study.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01095601


Sponsors and Collaborators
VIVUS, Inc.
Investigators
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Study Director: Shiyin Yee VIVUS, Inc.

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Responsible Party: Wesley Day, Vivus, Inc
ClinicalTrials.gov Identifier: NCT01095601     History of Changes
Other Study ID Numbers: TA-020
First Posted: March 30, 2010    Key Record Dates
Last Update Posted: January 7, 2011
Last Verified: January 2011

Keywords provided by VIVUS, Inc.:
avanafil
absoprion
bioavailability
food effect
dose-proportionality
TA-1790
Pharmacokinetics of avanafil