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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 18, 2014