A Single Dose Study Of Antimineralocorticoid Activity Of PF-03882845 In Healthy Volunteers
NCT01314898
ABOUT THIS STUDY
FOR MORE INFORMATION
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- 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.
- 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.
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Descriptive Information | ||||
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Brief Title ICMJE | A Single Dose Study Of Antimineralocorticoid Activity Of PF-03882845 In Healthy Volunteers | |||
Official Title ICMJE | 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. | |||
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 Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment | |||
Condition ICMJE | Healthy Volunteers | |||
Intervention ICMJE |
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Study Arms ICMJE | Experimental: Treatment
Interventions:
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Estimated Enrollment ICMJE | 12 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | June 2011 | |||
Actual Primary Completion Date | June 2011 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 55 Years (Adult) | |||
Accepts Healthy Volunteers ICMJE | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01314898 | |||
Other Study ID Numbers ICMJE | B0171007 B0171007 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Director, Clinical Trial Disclosure Group, Pfizer, Inc. | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Pfizer | |||
Verification Date | July 2011 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |