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

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: 3 mg PF-03882845; Drug: 10 mg PF-03882845; Drug: 30 mg PF-03882845; Drug: 100 mg PF-03882845; Drug: Spironolactone

• Registration Number: NCT01314898
• Lead Sponsor: Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2011-03-03
• Study First Submitted QC: 2011-03-11
• Study First Posted: 2011-03-15
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Status Verified: 2011-07
• Last Update Submitted: 2011-07-05
• Last Update Posted: 2011-07-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment	10 mg PF-03882845	-
Treatment	30 mg PF-03882845	-
Treatment	100 mg PF-03882845	-
Treatment	3 mg PF-03882845	-
Treatment	Spironolactone	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 New Haven, Connecticut, United States