To demonstrate the safety, pharmacokinetics and pharmacodynamics of drug candidate.
The study was terminated on June 19, 2009. Decision to terminate was based on Cohort 1 related safety concerns. An alternative clinical design was envisaged to better assess the benefit to risk.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
DOUBLE
Enrollment
10
The constituted dosage form for all doses were suspensions of drug candidate. Doses were administered once daily for 10 consecutive days.
The constituted dosage form for all doses will be suspensions of drug candidate. Doses will be once daily for 10 consecutive days.
The constituted dosage form for all doses will be suspensions of drug candidate. Doses will be once daily for 10 consecutive days.
Pfizer Investigational Site
New Haven, Connecticut, United States
Single Dose PK: Cmax, Tmax, and AUCtau; Multiple Dose PK (Assumed Steady State): Cmax(ss), Tmax(ss), AUC(tau,ss), half life, Cmin(ss), Cave(ss), Ae%, CL/F, V/F, CL renal; accumulation ratios AUC(tau,ss)/AUC(tau,sd) and Cmax(ss)/Cmax(sd).
Time frame: 13 days
Safety and tolerability as determined by adverse event reporting, clinical laboratory results, vital signs (supine blood pressure and heart rate), physical examinations, and electrocardiograms (ECGs).
Time frame: 13 days
Area under the effect curve (AUEC) for serum aldosterone and plasma renin activity (PRA) on Days 0, 1 and 10.
Time frame: 14 days
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The constituted dosage form for all doses will be suspensions of drug candidate. Doses will be once daily for 10 consecutive days.