HealthyPhase 1NCT01095601
Assess the Effect of Food on Avanafil Pharmacokinetic (PK), to Compare 2 Oral Formulations of Avanafil,and Investigate Dose Proportionality in Healthy Male Subjects
A Phase 1 study testing Avanafil in people with Healthy, run by VIVUS LLC.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Avanafil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Apr 2010to May 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- adult male subjects,
- 18 to 45 years of age,
- must be medically healthy with no clinically significant screening results.
Who cannot join
- 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;
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- 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.
About this study
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
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.
Read the 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.
- Conditions
- Healthy
- Being tested
- Avanafil
- Keywords
- avanafil, absoprion, bioavailability, food effect, dose-proportionality, TA-1790, Pharmacokinetics of avanafil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AvanafilDrug
Also called TA-1790
- 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
| Study group | Role | What they receive |
|---|---|---|
| Treatment A | Other | 2x100 mg Formulation II avanafil tablet, fasted Receives: Drug: Avanafil |
| Treatment B | Other | 2x100 mg Formulation II avanafil tablet, fed Receives: Drug: Avanafil |
| Treatment C | Other | 2x100 mg Formulation I avanafil tablet, fasted Receives: Drug: Avanafil |
| Treatment D | Other | 1x50 mg Formulation II avanafil tablet, fasted Receives: Drug: Avanafil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics of avanafil
Cmax and AUC of avanafil in each period
Measured: April through May 2010
Secondary outcomes (1)
Safety/AEs of avanafil
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.
Measured: April through May, 2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2010 (estimated)
- Study startApr 2010
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- VIVUS LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Shiyin Yee, Study director, VIVUS LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01095601
- Sponsor's protocol ID
- TA-020
- Status last verified
- Jan 2011
- First submitted
- 28 Mar 2010
- Last updated
- 7 Jan 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01095601
- Acronym / sponsor ID
- TA-020
- Conditions
- Healthy
- Keywords
- avanafil, absoprion, bioavailability, food effect, dose-proportionality, TA-1790, Pharmacokinetics of avanafil
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- VIVUS LLCIndustry (pharma, biotech, devices)
- Study start
- Apr 2010
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 30 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Other | Drug: Avanafil2x100 mg Formulation II avanafil tablet, fasted |
| Treatment B | Other | Drug: Avanafil2x100 mg Formulation II avanafil tablet, fed |
| Treatment C | Other | Drug: Avanafil2x100 mg Formulation I avanafil tablet, fasted |
| Treatment D | Other | Drug: Avanafil1x50 mg Formulation II avanafil tablet, fasted |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- adult male subjects,
- 18 to 45 years of age,
- must be medically healthy with no clinically significant screening results.
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AvanafilAlso: TA-1790* 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 | Drug | Treatment A, Treatment B, Treatment C, Treatment D |
Primary outcome
Pharmacokinetics of avanafil
Time frame: April through May 2010
Cmax and AUC of avanafil in each period
1 secondary outcome
Safety/AEs of avanafil
Time frame: April through May, 2010
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shiyin Yee study director
VIVUS LLC
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Avanafil in people with Healthy, run by VIVUS LLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics of avanafil (time frame: April through May 2010). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2011.