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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.

Tracking Information
First Submitted Date  ICMJE March 28, 2010
First Posted Date  ICMJE March 30, 2010
Last Update Posted Date January 7, 2011
Study Start Date  ICMJE April 2010
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 29, 2010)
Pharmacokinetics of avanafil [ Time Frame: April through May 2010 ]
Cmax and AUC of avanafil in each period
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 29, 2010)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Assess the Effect of Food on Avanafil Pharmacokinetic (PK), to Compare 2 Oral Formulations of Avanafil,and Investigate Dose Proportionality in Healthy Male Subjects
Official Title  ICMJE 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
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Healthy
Intervention  ICMJE 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
Study Arms  ICMJE
  • Treatment A
    2x100 mg Formulation II avanafil tablet, fasted
    Intervention: Drug: Avanafil
  • Treatment B
    2x100 mg Formulation II avanafil tablet, fed
    Intervention: Drug: Avanafil
  • Treatment C
    2x100 mg Formulation I avanafil tablet, fasted
    Intervention: Drug: Avanafil
  • Treatment D
    1x50 mg Formulation II avanafil tablet, fasted
    Intervention: Drug: Avanafil
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 5, 2011)
24
Original Estimated Enrollment  ICMJE
 (submitted: March 29, 2010)
60
Actual Study Completion Date  ICMJE May 2010
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01095601
Other Study ID Numbers  ICMJE TA-020
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wesley Day, Vivus, Inc
Study Sponsor  ICMJE VIVUS, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Shiyin Yee VIVUS, Inc.
PRS Account VIVUS, Inc.
Verification Date January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP