A Two-Part, Randomized, Double-Blind, Placebo-Controlled, Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of E2006 in Healthy Japanese and White Subjects
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Eisai Inc.
- Enrollment
- 32
- Primary Endpoint
- Adverse events (AEs ) as a measure of safety and tolerability
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 20 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
1
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).
Intervention: E2006 2.5 mg (Drug)
1
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).
Intervention: E2006 10 mg (Drug)
1
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).
Intervention: E2006 25 mg (Drug)
2
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.
Intervention: E2006 10 mg (Drug)
3
E2006-matched placebo tablets
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Adverse events (AEs ) as a measure of safety and tolerability
Time Frame: Up to 49 days
Vital signs as a measure of safety and tolerability
Time Frame: 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
Time Frame: Up to 49 days
Measured by the columbia suicide severity rating scale (C-SSRS)
Electrocardiogram (ECG) as a measure of safety and tolerability
Time Frame: 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
Time Frame: Up to 49 days
Pharmacokinetic (PK) profiles of E2006
Time Frame: 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
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported