Back to resultsA Randomized, Double-Blinded, Placebo-Controlled, Two-Way Crossover Study to Investigate the Safety and Toleration of Single Dose Sildenafil in Subjects Receiving Chronic UK-369,0031
Primary Purpose
Prostatic Hyperplasia, Urinary Bladder, Overactive, Erectile Dysfunction
Status
Completed
Phase
Phase 1
Locations
Singapore
Study Type
Interventional
Intervention
UK369,003
sildenafil
sildenafil matching placebo
Sponsored by
About this trial
This is an interventional basic science trial for Prostatic Hyperplasia
Eligibility Criteria
Inclusion Criteria:
- Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
- Healthy male subjects between the ages of 40 and 55 years, inclusive
- Body Mass Index (BMI) of approximately 18 to 30 kg/m2; and a total body weight >50 kg (110 lbs).
Exclusion Criteria:
- Evidence or history of clinically significant haematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
- Loss of vision in one eye due to non-arteritic ischemic optic neuropathy (NAION) regardless of whether or not this event was temporally associated with the use of a PDE5 inhibitor.
Sites / Locations
- Pfizer Investigational Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
UK369,003 + Placebo or sildenafil
Arm Description
All subjects will receive 17 days daily dosing of UK-369,003 100 mg MR Subjects will receive single oral doses of the following interactant treatments in a randomized order On Day 14, a single dose of sildenafil-matching placebo or 100 mg sildenafil and on Day 17 a single dose of 100 mg sildenafil or a sildenafil matching placebo
Outcomes
Primary Outcome Measures
Safety and toleration assessed by non-leading questioning, incidence of adverse events and laboratory testing.
Secondary Outcome Measures
Incidence of postural hypotension.
Standing and supine pulse rate (PR) at each postdose time.
Standing systolic and diastolic blood pressure (BP) and supine systolic and diastolic BP at each postdose time.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00814736
Brief Title
A Randomized, Double-Blinded, Placebo-Controlled, Two-Way Crossover Study to Investigate the Safety and Toleration of Single Dose Sildenafil in Subjects Receiving Chronic UK-369,0031
Official Title
A Randomized, Double-Blinded, Placebo-Controlled, Two-Way Crossover Study to Investigate The Safety And Toleration Of Single Dose Sildenafil In Subjects Receiving Chronic UK-369,003.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2008
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
September 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Pfizer
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To investigate the safety and overall tolerability of co-administration two PDE5 inhibitors UK369,003 and sildenafil
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Hyperplasia, Urinary Bladder, Overactive, Erectile Dysfunction
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
UK369,003 + Placebo or sildenafil
Arm Type
Experimental
Arm Description
All subjects will receive 17 days daily dosing of UK-369,003 100 mg MR Subjects will receive single oral doses of the following interactant treatments in a randomized order On Day 14, a single dose of sildenafil-matching placebo or 100 mg sildenafil and on Day 17 a single dose of 100 mg sildenafil or a sildenafil matching placebo
Intervention Type
Drug
Intervention Name(s)
UK369,003
Intervention Description
oral tablet, once a day
Intervention Type
Drug
Intervention Name(s)
sildenafil
Other Intervention Name(s)
viagra
Intervention Description
single oral dose on day 14 or day 17
Intervention Type
Drug
Intervention Name(s)
sildenafil matching placebo
Intervention Description
single oral dose on day 14 or day 17
Primary Outcome Measure Information:
Title
Safety and toleration assessed by non-leading questioning, incidence of adverse events and laboratory testing.
Time Frame
hours
Secondary Outcome Measure Information:
Title
Incidence of postural hypotension.
Time Frame
hours
Title
Standing and supine pulse rate (PR) at each postdose time.
Time Frame
hours
Title
Standing systolic and diastolic blood pressure (BP) and supine systolic and diastolic BP at each postdose time.
Time Frame
hours
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
Healthy male subjects between the ages of 40 and 55 years, inclusive
Body Mass Index (BMI) of approximately 18 to 30 kg/m2; and a total body weight >50 kg (110 lbs).
Exclusion Criteria:
Evidence or history of clinically significant haematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
Loss of vision in one eye due to non-arteritic ischemic optic neuropathy (NAION) regardless of whether or not this event was temporally associated with the use of a PDE5 inhibitor.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Singapore
ZIP/Postal Code
188770
Country
Singapore
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3711051&StudyName=A%20randomized%2C%20double-blinded%2C%20placebo-controlled%2C%20two-way%20crossover%20study%20to%20investigate%20the%20safety%20and%20toleration%20of%20single%20dose%20Silden
Description
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Learn more about this trial
A Randomized, Double-Blinded, Placebo-Controlled, Two-Way Crossover Study to Investigate the Safety and Toleration of Single Dose Sildenafil in Subjects Receiving Chronic UK-369,0031
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