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.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01314898

Enrollment

Registered

2011-03-15

Start date

2011-03-31

Completion date

2011-06-30

Last updated

2011-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

Keywords

Single dose, cross-over, active-control, placebo control, antimineralocorticoid activity

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.

Interventions

DRUG3 mg PF-03882845

3 mg PF-03882845, single oral dose

DRUG10 mg PF-03882845

10 mg PF-03882845, single oral dose

DRUG30 mg PF-03882845

30 mg PF-03882845, single oral dose

DRUG100 mg PF-03882845

100 mg PF-03882845, single oral dose

DRUGSpironolactone

100 mg spironolactone, single oral dose

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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

* 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.

Design outcomes

Primary

Measure	Time frame
Twenty-four hour urinary Na/K ratio (AUC(0-24)).	0-24hr postdose per period

Secondary

Measure	Time frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026