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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00971802
First received: September 3, 2009
Last updated: February 22, 2010
Last verified: February 2010
  Purpose

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.


Condition Intervention Phase
Healthy Volunteers
Drug: PF-03882845 or Placebo
Phase 1

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

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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) [ Time Frame: 13 days ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: 13 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 [ Time Frame: 11 days ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: 9 days ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: 9 days ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: September 2009
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1
Healthy volunteers - PF-03882845 versus Placebo
Drug: PF-03882845 or Placebo
PF-03882845 20 mg or Placebo, daily for 10 days.
Experimental: Cohort 2
Healthy volunteers - PF-03882845 versus Placebo
Drug: PF-03882845 or Placebo
PF-03882845 60 mg or Placebo, daily for 10 days.
Experimental: Cohort 3
Healthy volunteers - PF-03882845 versus Placebo
Drug: PF-03882845 or Placebo
PF-03882845 120 mg or Placebo, daily for 10 days.
Experimental: Cohort 4
Healthy volunteers - PF-03882845 versus Placebo
Drug: PF-03882845 or Placebo
PF-03882845 185 mg or Placebo, daily for 10 days.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00971802

Locations
United States, Florida
Pfizer Investigational Site
South Miami, Florida, United States, 33143
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00971802     History of Changes
Other Study ID Numbers: B0171008
Study First Received: September 3, 2009
Last Updated: February 22, 2010
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on April 15, 2014