A Single Dose Study Of Antimineralocorticoid Activity Of PF-03882845 In Healthy Volunteers
A Phase 1, Double-Blind (Sponsor-Open), Placebo- And Active-Controlled, Single Dose, Crossover Study To Assess Antimineralocorticoid Activity Of Oral Pf-03882845 In Healthy Subjects.
1 other identifier
interventional
12
1 country
1
Brief Summary
24-hr urinary sodium/potassium ratio will be a sensitive biomarker of antimineralocorticoid activity. The dose-response relationship of the antimineralocorticoid activity of PF-03882845 can be established following single oral doses.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 healthy-volunteers
Started Mar 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2011
CompletedFirst Submitted
Initial submission to the registry
March 3, 2011
CompletedFirst Posted
Study publicly available on registry
March 15, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedJuly 6, 2011
July 1, 2011
3 months
March 3, 2011
July 5, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Twenty-four hour urinary Na/K ratio (AUC(0-24)).
0-24hr postdose per period
Secondary Outcomes (4)
Area Under the Curve(AUClast) from the time of dosing to the last data point of PF-03882845.
0-24 hr post dose per period
Time of Maximum concentration(Tmax) of PF-03882845.
0-24 hr post dose per period
Maximum concentration (Cmax) of PF-03882845.
0-24 hr post dose per period
Safety and tolerability: Physical examinations, adverse event monitoring, clinical safety laboratory assessments, vital sign measurements and 12-lead ECGs.
2 months
Study Arms (1)
Treatment
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Male and/or female healthy volunteers, age 18 to 55 years. Females must be of non-childbearing potential.
- 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, diet restrictions and other trial procedures.
You may not qualify if:
- Subjects with a supine BP \>140 mm Hg systolic or \>90 mm Hg diastolic or \<100 mm Hg systolic or \<60 mm Hg diastolic based on the average of the triplicate
- Serum potassium \>=5.1 mmol/L or \<3.5 mmol/L at screening, confirmed by a single repeat if deemed necessary.
- Estimated GFR \<60 mL/min/1.73 m2 using the Cockcroft-Gault formula measurement of the individual parameters following at least 5 minutes of rest at Screening.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (1)
Pfizer Investigational Site
New Haven, Connecticut, 06511, United States
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 3, 2011
First Posted
March 15, 2011
Study Start
March 1, 2011
Primary Completion
June 1, 2011
Study Completion
June 1, 2011
Last Updated
July 6, 2011
Record last verified: 2011-07