A Study To Evaluate The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of PF-03882845 In Healthy Volunteers

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00971802
• Other study ID #: B0171008
• Status: Completed
• Phase: Phase 1
• First received: September 3, 2009
• Last updated: February 22, 2010
• Start date: September 2009
• Est. completion date: February 2010

Study information

• Verified date: February 2010
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• PF-03882845 or Placebo
PF-03882845 20 mg or Placebo, daily for 10 days.
• PF-03882845 or Placebo
PF-03882845 60 mg or Placebo, daily for 10 days.
• PF-03882845 or Placebo
PF-03882845 120 mg or Placebo, daily for 10 days.
• PF-03882845 or Placebo
PF-03882845 185 mg or Placebo, daily for 10 days.

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	South Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)		13 days	No
Primary	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.		13 days	No
Secondary	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		11 days	No
Secondary	Change from baseline(Day 0) to Day8 in exploratory mRNA gene expression biomarkers (SGK1:Sodium-and Serum/glucocorticoid regulated kinase 1 gene,ENaCa:Epithelial Sodium Channel alpha subunit,ENaC?:Epithelial Sodium Channel gamma		9 days	No
Secondary	subunit,MR: Mineral corticoid Receptor,ACTß:Beta Actin) after administration of PF-03882845 or placebo.These results will not be included in the study report		9 days	No

External Links

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