Evaluation of the Safety, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of E2609 in Healthy Subjects

PHASE1CompletedINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

December 31, 2011

Primary Completion Date

July 31, 2012

Study Completion Date

November 30, 2012

Conditions
Healthy
Interventions
DRUG

E2609

E2609 to be administered for 14 days, concurrently with placebo controls. Doses will be 25, 50, and 200 mg once daily by the oral route, each dose administered to a separate cohort (group) of subjects. After each dose has been administered to all subjects in a given cohort, safety and tolerability findings will be evaluated and a decision made by the sponsor and investigators as to whether or not to proceed to the next higher dose.

DRUG

Placebo

E2609 to be administered for 14 days, concurrently with placebo controls. Doses will be 25, 50, and 200 mg once daily by the oral route, each dose administered to a separate cohort (group) of subjects. After each dose has been administered to all subjects in a given cohort, safety and tolerability findings will be evaluated and a decision made by the sponsor and investigators as to whether or not to proceed to the next higher dose.

Trial Locations (1)

32806

Compass Research Phase 1, LLC, Orlando

All Listed Sponsors
lead

Eisai Inc.

INDUSTRY

NCT01511783 - Evaluation of the Safety, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of E2609 in Healthy Subjects | Biotech Hunter | Biotech Hunter