NCT00971802

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P50-P75 for phase_1 healthy-volunteers

Timeline
Completed

Started Sep 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

September 3, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 4, 2009

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
Last Updated

February 23, 2010

Status Verified

February 1, 2010

Enrollment Period

5 months

First QC Date

September 3, 2009

Last Update Submit

February 22, 2010

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Secondary Outcomes (3)

  • 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

  • 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

    9 days

  • 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

    9 days

Study Arms (4)

Cohort 1

EXPERIMENTAL

Healthy volunteers - PF-03882845 versus Placebo

Drug: PF-03882845 or Placebo

Cohort 2

EXPERIMENTAL

Healthy volunteers - PF-03882845 versus Placebo

Drug: PF-03882845 or Placebo

Cohort 3

EXPERIMENTAL

Healthy volunteers - PF-03882845 versus Placebo

Drug: PF-03882845 or Placebo

Cohort 4

EXPERIMENTAL

Healthy volunteers - PF-03882845 versus Placebo

Drug: PF-03882845 or Placebo

Interventions

PF-03882845 or PlaceboDRUG

PF-03882845 20 mg or Placebo, daily for 10 days.

Cohort 1

Eligibility Criteria

Age18 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pfizer Investigational Site

South Miami, Florida, 33143, United States

Location

Related Links

MeSH Terms

Interventions

(3S,3aR)-2-(3-chloro-4-cyanophenyl)-3-cyclopentyl-3,3a,4,5-tetrahydro-2H-benzo(g)indazole-7-carboxylic acid

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 3, 2009

First Posted

September 4, 2009

Study Start

September 1, 2009

Primary Completion

February 1, 2010

Study Completion

February 1, 2010

Last Updated

February 23, 2010

Record last verified: 2010-02

Locations

US(1)