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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Urinary Bladder, Overactive; Erectile Dysfunction; Prostatic Hyperplasia

Treatments: Drug: sildenafil matching placebo; Drug: sildenafil; Drug: UK369,003

Study type: Interventional

Funder types: Industry

Identifiers

NCT00814736

A3711051

Details and patient eligibility

About

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

Enrollment: 22 patients

Sex: Male

Ages: 40 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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22 participants in 1 patient group

UK369,003 + Placebo or sildenafil

Experimental group

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

Treatment:

Drug: sildenafil matching placebo

Drug: sildenafil

Drug: UK369,003