Pharmacodynamic and safety analyses
PD, orthostatic
ADVERSE EVENTS
Plasma PD measures included concentrations of aldosterone, 18-hydroxycorticosterone, corticosterone, 11-deoxycorticosterone, cortisol (free and total), 11-deoxycortisol, ACTH, sodium, chloride, and potassium. AUCs were calculated using a noncompartmental analysis and the linear trapezoidal/linear interpolation method. Urine PD measures included concentrations of aldosterone, cortisol (free and total), tetrahydroaldosterone, sodium, chloride, potassium, creatinine, and phosphorus. Other PD measures were seated, orthostatic, and positional changes in vital signs, as well as changes in body weight and BMI. Safety assessments involved adverse events, physical examinations, ECGs, orthostatic vital signs, and clinical laboratory evaluations.