The purpose of the study is to evaluate the safety and tolerability of PF-04995274 after administration of a single dose to healthy volunteers, and to evaluate the plasma drug concentrations after single dose in healthy volunteers.
The purpose is to evaluate the safety and pharmacokinetics of a single dose of PF-04995274 in healthy adult volunteers.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
DOUBLE
Enrollment
28
Planned single PO 0.15mg, 1.5mg, 15mg doses of PF-04995274 interleaved with cohort 2 such that doses escalate from 0.15 mg to 50 mg.
Planned single PO 0.5mg, 5mg, 50mg doses of PF-04995274, interleaved with cohort 2 such that doses escalate from 0.15 mg to 50 mg interleaved with cohort 2 such that doses escalate from 0.15 mg to 50 mg.
Planned single PO 120mg and 210mg doses of PF-04995274
Pfizer Investigational Site
Brussels, Belgium
Safety Endpoints (AE's, Vital signs (supine & standing BP, PR), Triplicate ECG, 8 hours of cardiac telemetry postdose, Clinical safety laboratory endpoints, Digit Symbol Substitution Test (DSST), Drug Effect Questionnaire (DEQ), Clinical
Time frame: up to 21 days post dose
examinations)
Time frame: up to 21 days post dose
Cmax, Tmax, AUClast, AUCinf, and t1/2 of PF 04995274, as the data permit.
Time frame: up to 7 days post dose
Cmax, Tmax, AUClast, AUCinf, and t1/2 of PF 05082547, as the data permit.
Time frame: up to 7 days post dosing
Plasma aldosterone concentrations
Time frame: through 1 day post dosing
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
single PO dose of PF-04995274; dosage to be determined by safety and pharmacokinetic data