NCT01463098View on ClinicalTrials.gov

A 2-Part Single Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of E2006

PHASE1CompletedINTERVENTIONAL
Enrollment

122

Participants

Timeline

Start Date

October 5, 2011

Primary Completion Date

August 11, 2012

Study Completion Date

August 11, 2012

Conditions
Insomnia
Interventions
DRUG

E2006 1.0 mg

E2006 1.0 mg capsule.

DRUG

E2006 2.5 mg

E2006 2.5 mg capsule.

DRUG

E2006 5.0 mg

E2006 5.0 mg (2 capsules of 2.5 mg each).

DRUG

E2006 10.0 mg

E2006 10.0 mg capsule.

DRUG

E2006 25.0 mg

E2006 25.0 mg (2 capsules of 10 mg each and 2 capsules of 2.5 mg each).

DRUG

E2006 50.0 mg

E2006 50.0 mg capsule.

DRUG

E2006 100 mg

E2006 100 mg (2 capsules of 50 mg each).

DRUG

E2006 200 mg

E2006 200 mg (4 capsules of 50 mg each).

DRUG

Zolpidem 10 mg

Zolpidem 10 mg immediate release tablet.

DRUG

E2006 Matched Placebo or Zolpidem Matched Placebo

E2006-matched placebo capsules or zolpidem-matched placebo tablets.

DRUG

E2006 Matched Placebo

E2006-matched placebo capsule.

Trial Locations (2)

10019

Clinilabs, Inc., New York

Unknown

Community Research, Cincinnati

All Listed Sponsors
lead

Eisai Inc.

INDUSTRY

NCT01463098 - A 2-Part Single Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of E2006 | Biotech Hunter | Biotech Hunter