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

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.

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

Study Overview

• Status: Completed
• Conditions: Urinary Bladder, Overactive; Prostatic Hyperplasia; Erectile Dysfunction
• Intervention / Treatment: Drug: UK369,003; Drug: sildenafil; Drug: sildenafil matching placebo

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Phase 1

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 188770
    • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: UK369,003 + Placebo or 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	Drug: UK369,003; oral tablet, once a day; Drug: sildenafil; single oral dose on day 14 or day 17; Other Names: viagra; Drug: sildenafil matching placebo; single oral dose on day 14 or day 17

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Safety and toleration assessed by non-leading questioning, incidence of adverse events and laboratory testing.	hours

Secondary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: August 1, 2008
• Primary Completion (Actual): September 1, 2008
• Study Completion (Actual): September 1, 2008

Study Registration Dates

• First Submitted: November 3, 2008
• First Submitted That Met QC Criteria: December 22, 2008
• First Posted (Estimate): December 25, 2008

Study Record Updates

• Last Update Posted (Estimate): December 25, 2008
• Last Update Submitted That Met QC Criteria: December 22, 2008
• Last Verified: December 1, 2008

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Prostatic Diseases; Sexual Dysfunctions, Psychological; Sexual Dysfunction, Physiological; Urinary Bladder, Overactive; Prostatic Hyperplasia; Hyperplasia; Erectile Dysfunction; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Urological Agents; Enzyme Inhibitors; Phosphodiesterase Inhibitors; Phosphodiesterase 5 Inhibitors; Sildenafil Citrate
• Other Study ID Numbers: A3711051