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

Phase 1

Completed

• Conditions: Prostatic Hyperplasia; Urinary Bladder, Overactive; Erectile Dysfunction
• Interventions: Drug: UK369,003; Drug: sildenafil; Drug: sildenafil matching placebo

• Registration Number: NCT00814736
• Lead Sponsor: Pfizer

Brief Summary

To investigate the safety and overall tolerability of co-administration two PDE5 inhibitors UK369,003 and sildenafil

Detailed Description

Not available

Study Timeline

• Study Start: 2008-08
• Primary Completion: 2008-09
• Study Completion: 2008-09
• Study First Submitted: 2008-11-03
• Status Verified: 2008-12
• Study First Submitted QC: 2008-12-22
• Last Update Submitted: 2008-12-22
• Study First Posted: 2008-12-25
• Last Update Posted: 2008-12-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 22

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
UK369,003 + Placebo or sildenafil	UK369,003	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
UK369,003 + Placebo or sildenafil	sildenafil	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
UK369,003 + Placebo or sildenafil	sildenafil matching placebo	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

Primary Outcome Measures

Name	Time	Method
Safety and toleration assessed by non-leading questioning, incidence of adverse events and laboratory testing.	hours

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇸🇬 Singapore, Singapore