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OpenTrials
Completed

NCT Number: NCT01314898

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

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.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

New Haven, Connecticut, 06511, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

3 mg PF-03882845

Drug

3 mg PF-03882845, single oral dose

10 mg PF-03882845

Drug

10 mg PF-03882845, single oral dose

30 mg PF-03882845

Drug

30 mg PF-03882845, single oral dose

100 mg PF-03882845

Drug

100 mg PF-03882845, single oral dose

Spironolactone

Drug

100 mg spironolactone, single oral dose

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

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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.

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Mar 15, 2011
Registry last updated
Jul 6, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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