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CompletedNCT01314898Updated Jul 6, 2011

A Single Dose Study Of Antimineralocorticoid Activity Of PF-03882845 In Healthy Volunteers

A Phase 1 interventional study of 3 mg PF-03882845 and 10 mg PF-03882845 in Healthy Volunteers, sponsored by Pfizer. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-07-06.

Sponsored by Pfizer · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
12
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Healthy Volunteers

Keywords

  • Single dose
  • cross-over
  • active-control
  • placebo control
  • antimineralocorticoid activity
03

In context

Lead sponsor

Pfizer is the lead sponsor of 3,323 studies on the registry; 145 are open to participants now.

Of its 597 completed or terminated interventional studies of FDA-regulated products, 391 (65%) have results posted.

Browse Pfizer studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
12 participants (estimated)

Study arms

  • Experimental
    Treatment

    Drug: 3 mg PF-03882845 · Drug: 10 mg PF-03882845 · Drug: 30 mg PF-03882845 · Drug: 100 mg PF-03882845 · Drug: Spironolactone

Interventions

06

What researchers measure

Primary outcomes

  1. Twenty-four hour urinary Na/K ratio (AUC(0-24)).

    Time frame: 0-24hr postdose per period

Secondary outcomes

  1. Area Under the Curve(AUClast) from the time of dosing to the last data point of PF-03882845.

    Time frame: 0-24 hr post dose per period

  2. Time of Maximum concentration(Tmax) of PF-03882845.

    Time frame: 0-24 hr post dose per period

  3. Maximum concentration (Cmax) of PF-03882845.

    Time frame: 0-24 hr post dose per period

  4. Safety and tolerability: Physical examinations, adverse event monitoring, clinical safety laboratory assessments, vital sign measurements and 12-lead ECGs.

    Time frame: 2 months

07

Study locations

1 site
  • Pfizer Investigational Site
    New Haven, Connecticut 06511, United States
08

References and documents

09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Mar 2011, a primary completion of Jun 2011 and a completion of Jun 2011. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 3, 2011
First posted
Mar 15, 2011
Start
Mar 2011
Primary completionActual
Jun 2011
CompletionActual
Jun 2011
Last update
Jul 6, 2011
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 6, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01314898
Lead sponsor
Pfizer
First posted
Mar 15, 2011
Start date
Mar 2011
Primary completion
Jun 2011
Completion
Jun 2011
Last update
Jul 6, 2011

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2011. You cannot join it, but the record below documents what was studied.

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