A Thorough EKG Safety Study of TA-1790 (Avanafil)
Primary Purpose
Erectile Dysfunction
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
moxifloxacin
avanafil
avanafil
sugar pill
Sponsored by
About this trial
This is an interventional treatment trial for Erectile Dysfunction
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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.
Sites / Locations
- Covance Phase 1 Clinical Unit
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Placebo Comparator
Active Comparator
Experimental
Experimental
Arm Label
placebo
moxifloxacin
avanafil therapeutic
avanafil supratherapeutic
Arm Description
avanafil 100mg - therapeutic dose
avanafil 800mg - supratherapeutic dose
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT00769041
First Posted
October 6, 2008
Last Updated
January 5, 2011
Sponsor
VIVUS LLC
Collaborators
Covance
1. Study Identification
Unique Protocol Identification Number
NCT00769041
Brief Title
A Thorough EKG Safety Study of TA-1790 (Avanafil)
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
January 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
VIVUS LLC
Collaborators
Covance
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erectile Dysfunction
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
57 (Actual)
8. Arms, Groups, and Interventions
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Title
moxifloxacin
Arm Type
Active Comparator
Arm Title
avanafil therapeutic
Arm Type
Experimental
Arm Description
avanafil 100mg - therapeutic dose
Arm Title
avanafil supratherapeutic
Arm Type
Experimental
Arm Description
avanafil 800mg - supratherapeutic dose
Intervention Type
Drug
Intervention Name(s)
moxifloxacin
Intervention Description
400mg
Intervention Type
Drug
Intervention Name(s)
avanafil
Intervention Description
100mg single dose
Intervention Type
Drug
Intervention Name(s)
avanafil
Intervention Description
800mg single dose
Intervention Type
Drug
Intervention Name(s)
sugar pill
Intervention Description
single dose
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chuck Bowden, M.D.
Organizational Affiliation
VIVUS LLC
Official's Role
Study Director
Facility Information:
Facility Name
Covance Phase 1 Clinical Unit
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53704
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Thorough EKG Safety Study of TA-1790 (Avanafil)
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