Erectile Dysfunction, Prostatic Hyperplasia, Urinary Bladder, Overactive
Conditions
Brief summary
To investigate the safety and overall tolerability of co-administration two PDE5 inhibitors UK369,003 and sildenafil
Interventions
DRUGUK369,003
oral tablet, once a day
DRUGsildenafil
single oral dose on day 14 or day 17
DRUGsildenafil matching placebo
single oral dose on day 14 or day 17
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
40 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and toleration assessed by non-leading questioning, incidence of adverse events and laboratory testing. | hours |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Singapore
Outcome results
None listed