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
1 other identifier
interventional
22
1 country
1
Brief Summary
To investigate the safety and overall tolerability of co-administration two PDE5 inhibitors UK369,003 and sildenafil
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Aug 2008
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2008
CompletedFirst Submitted
Initial submission to the registry
November 3, 2008
CompletedFirst Posted
Study publicly available on registry
December 25, 2008
CompletedDecember 25, 2008
December 1, 2008
1 month
November 3, 2008
December 22, 2008
Conditions
Outcome Measures
Primary Outcomes (1)
Safety and toleration assessed by non-leading questioning, incidence of adverse events and laboratory testing.
hours
Secondary Outcomes (3)
Incidence of postural hypotension.
hours
Standing and supine pulse rate (PR) at each postdose time.
hours
Standing systolic and diastolic blood pressure (BP) and supine systolic and diastolic BP at each postdose time.
hours
Study Arms (1)
UK369,003 + Placebo or sildenafil
EXPERIMENTALAll 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
Interventions
single oral dose on day 14 or day 17
single oral dose on day 14 or day 17
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (1)
Pfizer Investigational Site
Singapore, 188770, Singapore
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 3, 2008
First Posted
December 25, 2008
Study Start
August 1, 2008
Primary Completion
September 1, 2008
Study Completion
September 1, 2008
Last Updated
December 25, 2008
Record last verified: 2008-12