Avanfil ADMEPhase 1NCT00914511
A Pharmacokinetic Study of Avanfil in Healthy Young Male Subjects
A Phase 1 study testing avanafil 200mg in people with Avanfil ADME and Semen Exposure, run by VIVUS LLC at 1 site in United States.
Trial summary
The purposes of this study are to: Determine the effect of the study drug on sperm and semen of healthy young male subjects. Determine the effect of age on the amount of study drug in the blood of healthy subjects Learn about the safety of the study drug. Learn how subjects tolerate the study drug. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Avanfil ADME, Semen Exposure, Sperm Function
- What is being tested?
- avanafil 200mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- May 2009to Jun 2009
- 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 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Cohort A: Adult male subjects of 18 to 45 years of age inclusive Cohort B: Adult male subjects at least 65 years of age
- All subjects must be medically healthy with no clinically significant screening results.
- Male subjects should be willing to use a condom and spermicide during sexual activity for 90 days after last dosing of Avanafil and be willing to not donate sperm for 90 days after dosing.
Who cannot join
- Major exclusion criteria for all subjects include:
- History or clinical evidence of clinically relevant cardiovascular (including thromboembolic disorders), hepatic, renal, hematologic, 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
- Allergy to or previous adverse events with PDE5 inhibitors
Show all 15Show fewer
- 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 test
- Positive urine drug screen
- Positive urine cotinine test, positive serology for HIV, HCV, HBsAg
- Young males who have undergone vasectomy cannot participate in this-study
- Additional exclusion criteria are listed in Section 4.2.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Single-Center, Open-Label, Non-Randomized, Two-Cohort Study to Assess the Effect of Age on the Pharmacokinetics of Avanafil And To Determine Avanafil Semen Exposure and the Acute Effect of Avanafil on Sperm Function in Healthy Young Male Subjects Following a Single Oral Dose of 200 mg
The purposes of this study are to:
- Determine the effect of the study drug on sperm and semen of healthy young male subjects.
- Determine the effect of age on the amount of study drug in the blood of healthy subjects
- Learn about the safety of the study drug.
- Learn how subjects tolerate the study drug.
Read the detailed description
This single-center, open-label, non-randomized, two-cohort, single-dose pharmacokinetic study will be conducted at a single site in the United States, in which at least 18 young (18-45 years, inclusive) male subjects in Cohort A and 14 elderly (65 years or older) males in Cohort B will be enrolled and dosed to achieve a total of at least 14 completed young subjects and 12 elderly subjects. Seminal fluid and plasma will be collected from Cohort A, whereas only plasma samples will be collected from Cohort B.
- Conditions
- Avanfil ADME, Semen Exposure, Sperm Function
- Being tested
- avanafil 200mg
- Keywords
- Semen, Sperm, Avanafil, Pharmacokinetics, Elderly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
avanafil 200mgDrug
single dose tablet of 200mg avanafil
avanafil 200mgDrug
single tablet dose of 200mg avanafil
| Study group | Role | What they receive |
|---|---|---|
| Healthy young males | Experimental | Healthy young males age 18-45, inclusive Receives: Drug: avanafil 200mg |
| Elderly males | Experimental | Elderly males 65 years of age and older Receives: Drug: avanafil 200mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma pharmacokinetic parameters of avanafil and its metabolites will be evaluated including AUC (0-t), AUC(0-inf), Cmax, fu, t1/2, and tmax; Sperm motility, function and morphology; Avanafil exposure in seminal fluid
Measured: pre-dose (baseline) through 24 hours post-dose
Secondary outcomes (1)
adverse events (each study visit); laboratory evaluations; electrocardiogram and physical examination; vital signs will be assessed at various times during the study.
Measured: pre-dose (baseline) through 24 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2009 (estimated)
- Study startMay 2009
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Avanfil ADMEStudies 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- VIVUS LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Shiyin Yee, PhD, Study director, VIVUS LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00914511
- Sponsor's protocol ID
- TA-014
- Status last verified
- Jan 2011
- First submitted
- 3 Jun 2009
- Last updated
- 7 Jan 2011
- Results posted
- No
- Data monitoring committee
- 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-Center, Open-Label, Non-Randomized, Two-Cohort Study to Assess the Effect of Age on the Pharmacokinetics of Avanafil And To Determine Avanafil Semen Exposure and the Acute Effect of Avanafil on Sperm Function in Healthy Young Male Subjects Following a Single Oral Dose of 200 mg
- ClinicalTrials.gov ID
- NCT00914511
- Acronym / sponsor ID
- TA-014
- Conditions
- Avanfil ADME, Semen Exposure, Sperm Function
- Keywords
- Semen, Sperm, Avanafil, Pharmacokinetics, Elderly
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- VIVUS LLCIndustry (pharma, biotech, devices)
- Study start
- May 2009
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 5 Jun 2009 (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.
The purposes of this study are to:
- Determine the effect of the study drug on sperm and semen of healthy young male subjects.
- Determine the effect of age on the amount of study drug in the blood of healthy subjects
- Learn about the safety of the study drug.
- Learn how subjects tolerate the study drug.
Detailed description
This single-center, open-label, non-randomized, two-cohort, single-dose pharmacokinetic study will be conducted at a single site in the United States, in which at least 18 young (18-45 years, inclusive) male subjects in Cohort A and 14 elderly (65 years or older) males in Cohort B will be enrolled and dosed to achieve a total of at least 14 completed young subjects and 12 elderly subjects. Seminal fluid and plasma will be collected from Cohort A, whereas only plasma samples will be collected from Cohort B.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy young males | Experimental | Drug: avanafil 200mgHealthy young males age 18-45, inclusive |
| Elderly males | Experimental | Drug: avanafil 200mgElderly males 65 years of age and older |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Cohort A: Adult male subjects of 18 to 45 years of age inclusive Cohort B: Adult male subjects at least 65 years of age
- All subjects must be medically healthy with no clinically significant screening results.
- Male subjects should be willing to use a condom and spermicide during sexual activity for 90 days after last dosing of Avanafil and be willing to not donate sperm for 90 days after dosing.
Key exclusion criteria (15 listed)
- History or clinical evidence of clinically relevant cardiovascular (including thromboembolic disorders), hepatic, renal, hematologic, 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
- Allergy to or previous adverse events with PDE5 inhibitors
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 |
|---|---|---|
| avanafil 200mgsingle dose tablet of 200mg avanafil | Drug | Healthy young males |
| avanafil 200mgsingle tablet dose of 200mg avanafil | Drug | Elderly males |
Primary outcome
Plasma pharmacokinetic parameters of avanafil and its metabolites will be evaluated including AUC (0-t), AUC(0-inf), Cmax, fu, t1/2, and tmax; Sperm motility, function and morphology; Avanafil exposure in seminal fluid
Time frame: pre-dose (baseline) through 24 hours post-dose
1 secondary outcome
adverse events (each study visit); laboratory evaluations; electrocardiogram and physical examination; vital signs will be assessed at various times during the study.
Time frame: pre-dose (baseline) through 24 hours post-dose
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.
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, PhD study director
VIVUS LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing avanafil 200mg in people with Avanfil ADME and Semen Exposure, run by VIVUS LLC at 1 site in United States.
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 15 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.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Plasma pharmacokinetic parameters of avanafil and its metabolites will be evaluated including AUC (0-t), AUC(0-inf), Cmax, fu, t1/2, and tmax; Sperm motility, function and morphology; Avanafil exposure in seminal fluid (time frame: pre-dose (baseline) through 24 hours post-dose). 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.