A Two-Part Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of E2006 in Healthy Japanese and White Subjects
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|ClinicalTrials.gov Identifier: NCT02039089|
Recruitment Status : Completed
First Posted : January 17, 2014
Last Update Posted : November 3, 2015
|Condition or disease||Intervention/treatment||Phase|
|Healthy Volunteers||Drug: E2006 2.5 mg Drug: E2006 10 mg Drug: E2006 25 mg Drug: Placebo||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||32 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||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|
|Study Start Date :||January 2014|
|Actual Primary Completion Date :||May 2014|
|Actual Study Completion Date :||May 2014|
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).
Drug: E2006 2.5 mg
Drug: E2006 10 mg
Drug: E2006 25 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.
Drug: E2006 10 mg
Placebo Comparator: 3
E2006-matched placebo tablets
- 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.
- Adverse events (AEs ) as a measure of safety and tolerability [ Time Frame: Up to 49 days ]
- Suicidality as a measure of safety and tolerability [ Time Frame: Up to 49 days ]Measured by the columbia suicide severity rating scale (C-SSRS)
- 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
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02039089
|United States, California|
|Glendale, California, United States|