Erectile DysfunctionPhase 1NCT00769041
A Thorough EKG Safety Study of TA-1790 (Avanafil)
A Phase 1 study testing moxifloxacin, avanafil and sugar pill in people with Erectile Dysfunction, run by VIVUS LLC at 1 site in United States.
Trial summary
This study is to assess whether treatment with a therapeutic (100 mg) or supratherapeutic (800 mg) dose of avanafil has the potential to cause QT/QTc prolongation in healthy volunteers. 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
- Erectile Dysfunction
- What is being tested?
- moxifloxacin, avanafil and sugar pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2008to Jan 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 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male;
- Between 18 and 45 years of age, inclusive;
- Have a BMI ranging between 19 and 28 kg/m2, inclusive;
- Have no clinically significant abnormal findings on the physical examination, ECG, blood pressure, HR, medical history, or clinical laboratory results during Screening;
- Be willing and able to comply with all trial requirements; and
- Have given written informed consent.
Who cannot join
- Subjects who have participated in another clinical trial of an within the last 30 days or are currently participating in another trial of an investigational drug.
- Subjects who have participated in a previous clinical trial with avanafil.
- Subjects who have a known allergy or hypersensitivity to avanafil, sildenafil (Viagra®), vardenafil (Levitra®), tadalafil (Cialis®) or any of the components of these drug products; moxifloxacin or its components; or to any quinolone antibiotic.
- Subjects who have experienced dose-limiting adverse effects during therapy with a PDE5
- Subjects who have any condition possibly affecting drug absorption
- Subjects who have evidence or history of clinically significant allergic (except for untreated, asymptomatic, seasonal allergies at time of dosing), hematological, endocrine,pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurological disease. Exceptions to these criteria (eg, stable, mild joint disease) may be made following discussions with the Medical Monitor.
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- Subjects with a medical history of or who have a positive serology test for human immunodeficiency virus (HIV), hepatitis B virus surface antigen (HBsAg), or hepatitis C virus (HCV).
- Subjects who have a history of drug or alcohol abuse or dependence within 18 months prior to Screening.
- Subjects who have donated blood or blood components within the 4 weeks prior to Period 1 Check-in.
- Subjects with laboratory values outside of the normal range for the local laboratory.
- Subjects who have a sustained supine SBP >140 mmHg or <100 mm Hg or a DBP >95 mmHg at Screening or baseline.
- Subjects who have a resting HR of <45 bpm or >100 bpm.
- Subjects who have an abnormal Screening ECG indicating a second- or third-degree atrioventricular (AV) block, or 1 or more of the following: QRS interval >110 msec, QTc interval >450 msec, PR interval >240 msec, or any rhythm other than sinus rhythm, which is interpreted by the Investigator to be clinically significant.
- Subjects who use or have used tobacco-containing products within the 6 months prior to Period 1 Check-in and throughout the study.
- Subjects who have consumed alcohol-, caffeine-, or xanthine-containing products within 72 hours prior to Period 1 Check-in and throughout the study.
- Subjects who test positive for drug(s) of abuse, alcohol, or cotinine at Screening or Check-in for any period.
- Subjects who have concomitant medication usage of any nitrate, trazadone, ketoconozole, erythromycin, cimetidine, androgen replacement therapy and/or use of other prescription or over-the-counter drugs that are known to interfere with metabolism by CYP3A4.
- Subjects who have used any drug that may prolong the QT/QTc interval within 30 days.
- Subjects who have used a prescription drug or over-the-counter or herbal medication within 14 days
- Subjects who are involved in the planning and/or conduct of the study.
- Subjects who, for any reason, are deemed by the Investigator to be inappropriate for this study, including subjects who are unable to communicate or to cooperate with the Investigator.
Trial locations and contacts
1 site in 1 country.
United States1 site
Covance Phase 1 Clinical Unit
Madison, Wisconsin, 53704
About this study
Official title: A Blinded, Randomized Crossover Trial to Define the ECG Effects of TA-1790 (Avanafil) Using a Single Clinical and a Supratherapeutic Dose Compared to Placebo and Moxifloxacin in Healthy Men: A Thorough ECG Trial
This study is to assess whether treatment with a therapeutic (100 mg) or supratherapeutic (800 mg) dose of avanafil has the potential to cause QT/QTc prolongation in healthy volunteers.
- Conditions
- Erectile Dysfunction
- Being tested
- moxifloxacin, avanafil, sugar pill
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
moxifloxacinDrug
400mg
avanafilDrug
100mg single dose
avanafilDrug
800mg single dose
sugar pillDrug
single dose
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | Not described Receives: Drug: sugar pill |
| moxifloxacin | Active comparator | Not described Receives: Drug: moxifloxacin |
| avanafil therapeutic | Experimental | avanafil 100mg - therapeutic dose Receives: Drug: avanafil |
| avanafil supratherapeutic | Experimental | avanafil 800mg - supratherapeutic dose Receives: Drug: avanafil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time-matched change from baseline in QTcI that provides optimization of QT correction of heart rate as compared to fixed exponent approaches such as QTcB or QTcF.
Measured: 24 Hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2008 (estimated)
- Study startOct 2008
- Primary completionJan 2009
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erectile DysfunctionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- VIVUS LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Covance
- Investigators
- Chuck Bowden, M.D., Study director, VIVUS LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00769041
- Sponsor's protocol ID
- TA-140
- Status last verified
- Jan 2011
- First submitted
- 6 Oct 2008
- 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 Blinded, Randomized Crossover Trial to Define the ECG Effects of TA-1790 (Avanafil) Using a Single Clinical and a Supratherapeutic Dose Compared to Placebo and Moxifloxacin in Healthy Men: A Thorough ECG Trial
- ClinicalTrials.gov ID
- NCT00769041
- Acronym / sponsor ID
- TA-140
- Conditions
- Erectile Dysfunction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- VIVUS LLCIndustry (pharma, biotech, devices)
- Collaborators
- Covance
- Study start
- Oct 2008
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 8 Oct 2008 (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 is to assess whether treatment with a therapeutic (100 mg) or supratherapeutic (800 mg) dose of avanafil has the potential to cause QT/QTc prolongation in healthy volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Drug: sugar pill |
| moxifloxacin | Active comparator | Drug: moxifloxacin |
| avanafil therapeutic | Experimental | Drug: avanafilavanafil 100mg - therapeutic dose |
| avanafil supratherapeutic | Experimental | Drug: avanafilavanafil 800mg - supratherapeutic dose |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Male;
- Between 18 and 45 years of age, inclusive;
- Have a BMI ranging between 19 and 28 kg/m2, inclusive;
- Have no clinically significant abnormal findings on the physical examination, ECG, blood pressure, HR, medical history, or clinical laboratory results during Screening;
- Be willing and able to comply with all trial requirements; and
Key exclusion criteria (21 listed)
- Subjects who have participated in another clinical trial of an within the last 30 days or are currently participating in another trial of an investigational drug.
- Subjects who have participated in a previous clinical trial with avanafil.
- Subjects who have a known allergy or hypersensitivity to avanafil, sildenafil (Viagra®), vardenafil (Levitra®), tadalafil (Cialis®) or any of the components of these drug products; moxifloxacin or its components; or to any quinolone antibiotic.
- Subjects who have experienced dose-limiting adverse effects during therapy with a PDE5
- Subjects who have any condition possibly affecting drug absorption
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 |
|---|---|---|
| moxifloxacin400mg | Drug | moxifloxacin |
| avanafil100mg single dose | Drug | avanafil therapeutic |
| avanafil800mg single dose | Drug | avanafil supratherapeutic |
| sugar pillsingle dose | Drug | placebo |
Primary outcome
Time-matched change from baseline in QTcI that provides optimization of QT correction of heart rate as compared to fixed exponent approaches such as QTcB or QTcF.
Time frame: 24 Hours
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.
Chuck Bowden, M.D. 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 moxifloxacin, avanafil and sugar pill in people with Erectile Dysfunction, 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 6 inclusion and 21 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. Some participants in this study may receive a placebo. 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?
Time-matched change from baseline in QTcI that provides optimization of QT correction of heart rate as compared to fixed exponent approaches such as QTcB or QTcF. (time frame: 24 Hours). 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; AzTrials last refreshed its copy on 7 Nov 2026.