A Two-Part Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of E2006 in Healthy Japanese and White Subjects

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: Placebo; Drug: E2006 2.5 mg; Drug: E2006 10 mg; Drug: E2006 25 mg

• Registration Number: NCT02039089
• Lead Sponsor: Eisai Inc.

Brief Summary

This study will be a single-center, multiple-dose, randomized, double-blind, placebo-controlled, parallel-group study in healthy male and female subjects. The study will consist of 2 parts: Part A (3 cohorts of healthy Japanese subjects dosed in the evening) and Part B (one cohort of healthy white subjects dosed in the evening). The cohorts will be conducted sequentially. Part A will be started first with the 2.5-mg dose cohort, followed by the 10-mg dose cohort and then the 25-mg dose cohort. Part B will be conducted in parallel with the 10-mg cohort of Part A, with the possibility of overlap.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-01-10
• Study First Submitted QC: 2014-01-16
• Study First Posted: 2014-01-17
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-02
• Last Update Posted: 2015-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3	Placebo	E2006-matched placebo tablets
1	E2006 25 mg	Part A: dose escalation of E2006 in Japanese subjects from 2.5 mg (1 x 2.5-mg tablet) up to 10 mg (1 x 10-mg tablet) then to 25 mg (2 x 10-mg tablet, 1 x 5-mg tablet).
1	E2006 2.5 mg	Part A: dose escalation of E2006 in Japanese subjects from 2.5 mg (1 x 2.5-mg tablet) up to 10 mg (1 x 10-mg tablet) then to 25 mg (2 x 10-mg tablet, 1 x 5-mg tablet).
1	E2006 10 mg	Part A: dose escalation of E2006 in Japanese subjects from 2.5 mg (1 x 2.5-mg tablet) up to 10 mg (1 x 10-mg tablet) then to 25 mg (2 x 10-mg tablet, 1 x 5-mg tablet).
2	E2006 10 mg	Part B: E2006 10 mg for White subjects that will be group matched to the Japanese subjects in the 10 mg period in Part A.

Primary Outcome Measures

Name	Time	Method
Adverse events (AEs ) as a measure of safety and tolerability	Up to 49 days
Vital signs as a measure of safety and tolerability	Up to 49 days	Vital sign measurements will include systolic and diastolic blood pressure (BP) and pulse rate
Suicidality as a measure of safety and tolerability	Up to 49 days	Measured by the columbia suicide severity rating scale (C-SSRS)
Electrocardiogram (ECG) as a measure of safety and tolerability	Up to 49 days	Twelve-lead ECGs will be obtained as a measure of safety and tolerability
Laboratory assessments as a measure of safety and tolerability	Up to 49 days
Pharmacokinetic (PK) profiles of E2006	Up to 49 days	The primary PK parameters are Cmax, tmax, AUC(0-T), AUC(0-24h), and t1/2, derived by non-compartmental analyses using the plasma concentration of E2006 and metabolites (as data permit).
Pharmacodynamic (PD) profile of E2006	Up to 49 days	acute effects of E2006 on sleepiness in the hour before bedtime as well as next-day residual sleepiness throughout the daytime hours subsequent to each dose using the KSS and PVT. Effects of E2006 on nighttime sleep will be evaluated using PSG. High-precision QT analyses (HPQT) will be performed using data from 24-hour Holter recordings. The time points of Holter readings will be corresponding to the PK time points.