Clinical trial NCT00971802: A Study To Evaluate The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of PF-03882845 In Healthy Volunteers
Official title: A Phase 1, Double-Blind (Sponsor Open), Randomized, Placebo- Controlled, Parallel Group, Oral Multiple-Dose Trial to Evaluate The Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PF-03882845 in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-09-04
Enrollment: 50
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: To evaluate the safety and tolerability of PF-03882845 in Healthy Volunteers. To evaluate the pharmacokinetics of PF-03882845 in Healthy Volunteers. To evaluate the pharmacodynamics of PF-03882845 in Healthy Volunteers.


Eligibility criteria: Inclusion Criteria:

* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs).
* Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion Criteria:

* Evidence or history of clinically significant disease.
* Past medical history of epididymitis, orchitis, sexually transmitted diseases (chlamydia, gonorrhea, etc.) or urinary tract infection.
* History of prostatitis or prostate surgery.
* Urinary catheterization or instrumentation within 12 months of screening. Inguinal or scrotal hernia.
* Current or history of congenital genital abnormalities.
* Baseline scrotal ultrasound scan showing unilateral or bilateral scrotal blood flow abnormalities or anatomic abnormalities (hydrocele, cysts, other), with the exception of small epididymal cysts and spermatoceles.
* Any condition possibly affecting drug absorption (eg, gastrectomy).
* Blood donation of approximately 1 pint (500 mL) within 56 days prior to dosing.
* History of sensitivity to spironolactone, eplerenone, or related compounds.
* Serum potassium \>5.5 mEq/L at screening or Day 0.

Primary outcomes:
measure: Single-Dose PK for PF-03382845: Cmax(ss), Tmax(ss), AUC(tau,ss), half life, Cmin(ss), Cave(ss), Ae%, CL/F, V/F, CL renal; accumulation ratios AUC(tau,ss)/AUC(tau,sd) and Cmax(ss)/Cmax(sd)
timeFrame: 13 days
measure: Safety and tolerability of PF-03382845 as determined by adverse event reporting, clinical laboratory results, vital signs (supine blood pressure and heart rate), physical examinations, electrocardiograms (ECGs) and potential sex hormone mediators.
timeFrame: 13 days
Secondary outcomes:
measure: Area under the effect curve (AUEC) for serum aldosterone and PRA on Day 0 and on Days 1 and 10 after administration of PF-03882845
timeFrame: 11 days
measure: Change from baseline(Day 0) to Day8 in exploratory mRNA gene expression biomarkers (SGK1:Sodium-and Serum/glucocorticoid regulated kinase 1 gene,ENaCα:Epithelial Sodium Channel alpha subunit,ENaCγ:Epithelial Sodium Channel gamma
timeFrame: 9 days
measure: subunit,MR: Mineral corticoid Receptor,ACTβ:Beta Actin) after administration of PF-03882845 or placebo.These results will not be included in the study report
timeFrame: 9 days
Other outcomes:
Locations:
city: South Miami
country: United States
facility: Pfizer Investigational Site
state: Florida
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: