Trial Outcomes & Findings for A 2-Part Single Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of E2006 (NCT NCT01463098)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

122 participants

Primary outcome timeframe

Baseline up to Day 11

Results posted on

2020-01-18

Participant Flow

Participants took part in the study at 2 investigative sites in United States from 05 October 2011 to 11 August 2012.

Part A: A total of 160 healthy participants were screened, of which 96 were screen failures and 64 were enrolled and randomized to receive study treatment. Part B: A total of 281 otherwise healthy participants with primary insomnia were screened, of which 223 were screen failures and 58 were enrolled and randomized to receive study treatment.

Participant milestones

Participant milestones
Measure	Part A: E2006 Matched Placebo Healthy participants received E2006-matched placebo, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 1.0 mg Healthy participants received E2006 1 milligram (mg), capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 2.5 mg Healthy participants received E2006 2.5 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 5 mg Healthy participants received E2006 5 mg (2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 10 mg Healthy participants received E2006 10 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 25 mg Healthy participants received E2006 25 mg (2 capsules of 10 mg each and 2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 50 mg Healthy participants received E2006 50 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 100 mg Healthy participants received E2006 100 mg (2 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 200 mg Healthy participants received E2006 200 mg (4 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part B: E2006 Matched Placebo or Zolpidem Matched Placebo Otherwise healthy participants with primary insomnia received E2006-matched placebo capsules or zolpidem-matched placebo tablets, orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1.	Part B: Zolpidem 10 mg Otherwise healthy participants with primary insomnia received zolpidem 10 mg immediate release, tablet, orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1.	Part B: E2006 2.5 mg Otherwise healthy participants with primary insomnia received E2006 2.5 mg, capsule, orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1.	Part B: E2006 10 mg Otherwise healthy participants with primary insomnia received E2006 10 mg, capsule, orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1.	Part B: E2006 25 mg Otherwise healthy participants with primary insomnia received E2006 25 mg (2 capsules of 10 mg each and 2 capsules of 2.5 mg each), orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1.
Part A (11 Days) STARTED	16	6	6	6	6	6	6	6	6	0	0	0	0	0
Part A (11 Days) COMPLETED	14	6	6	6	5	6	6	6	5	0	0	0	0	0
Part A (11 Days) NOT COMPLETED	2	0	0	0	1	0	0	0	1	0	0	0	0	0
Part B (11 Days) STARTED	0	0	0	0	0	0	0	0	0	12	11	13	10	12
Part B (11 Days) COMPLETED	0	0	0	0	0	0	0	0	0	12	11	12	10	12
Part B (11 Days) NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0	1	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Part A: E2006 Matched Placebo Healthy participants received E2006-matched placebo, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 10 mg Healthy participants received E2006 10 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 200 mg Healthy participants received E2006 200 mg (4 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part B: E2006 2.5 mg Otherwise healthy participants with primary insomnia received E2006 2.5 mg, capsule, orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1.
Part A (11 Days) Participant Choice	2	0	1	0
Part A (11 Days) Lost to Follow-up	0	1	0	0
Part B (11 Days) Participant Choice	0	0	0	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part A: E2006 Matched Placebo n=16 Participants Healthy participants received E2006-matched placebo, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 1.0 mg n=6 Participants Healthy participants received E2006 1 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 2.5 mg n=6 Participants Healthy participants received E2006 2.5 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 5 mg n=6 Participants Healthy participants received E2006 5 mg (2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 10 mg n=6 Participants Healthy participants received E2006 10 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 25 mg n=6 Participants Healthy participants received E2006 25 mg (2 capsules of 10 mg each and 2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 50 mg n=6 Participants Healthy participants received E2006 50 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 100 mg n=6 Participants Healthy participants received E2006 100 mg (2 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 200 mg n=6 Participants Healthy participants received E2006 200 mg (4 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part B: E2006 Matched Placebo or Zolpidem Matched Placebo n=12 Participants Otherwise healthy participants with primary insomnia received E2006-matched placebo capsules or zolpidem-matched placebo tablets, orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1.	Part B: Zolpidem 10 mg n=11 Participants Otherwise healthy participants with primary insomnia received zolpidem 10 mg immediate release, tablet, orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1.	Part B: E2006 2.5 mg n=13 Participants Otherwise healthy participants with primary insomnia received E2006 2.5 mg, capsule, orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1.	Part B: E2006 10 mg n=10 Participants Otherwise healthy participants with primary insomnia received E2006 10 mg, capsule, orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1.	Part B: E2006 25 mg n=12 Participants Otherwise healthy participants with primary insomnia received E2006 25 mg (2 capsules of 10 mg each and 2 capsules of 2.5 mg each), orally in the evening, 30 minutes prior to habitual bed time (lights-out) on Day 1.	Total n=122 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants	0 Participants n=3 Participants	0 Participants n=6 Participants	0 Participants n=114 Participants	0 Participants	0 Participants n=19 Participants	0 Participants n=4 Participants	0 Participants n=7 Participants	0 Participants n=7 Participants	0 Participants n=3 Participants
Age, Categorical Between 18 and 65 years	16 Participants n=99 Participants	6 Participants n=107 Participants	6 Participants n=206 Participants	6 Participants n=7 Participants	6 Participants n=31 Participants	6 Participants n=30 Participants	6 Participants n=3 Participants	6 Participants n=6 Participants	6 Participants n=114 Participants	12 Participants	11 Participants n=19 Participants	13 Participants n=4 Participants	10 Participants n=7 Participants	12 Participants n=7 Participants	122 Participants n=3 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants	0 Participants n=3 Participants	0 Participants n=6 Participants	0 Participants n=114 Participants	0 Participants	0 Participants n=19 Participants	0 Participants n=4 Participants	0 Participants n=7 Participants	0 Participants n=7 Participants	0 Participants n=3 Participants
Sex: Female, Male Female	8 Participants n=99 Participants	3 Participants n=107 Participants	3 Participants n=206 Participants	3 Participants n=7 Participants	3 Participants n=31 Participants	3 Participants n=30 Participants	3 Participants n=3 Participants	3 Participants n=6 Participants	3 Participants n=114 Participants	6 Participants	5 Participants n=19 Participants	6 Participants n=4 Participants	4 Participants n=7 Participants	6 Participants n=7 Participants	59 Participants n=3 Participants
Sex: Female, Male Male	8 Participants n=99 Participants	3 Participants n=107 Participants	3 Participants n=206 Participants	3 Participants n=7 Participants	3 Participants n=31 Participants	3 Participants n=30 Participants	3 Participants n=3 Participants	3 Participants n=6 Participants	3 Participants n=114 Participants	6 Participants	6 Participants n=19 Participants	7 Participants n=4 Participants	6 Participants n=7 Participants	6 Participants n=7 Participants	63 Participants n=3 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=99 Participants	2 Participants n=107 Participants	1 Participants n=206 Participants	2 Participants n=7 Participants	1 Participants n=31 Participants	1 Participants n=30 Participants	2 Participants n=3 Participants	3 Participants n=6 Participants	3 Participants n=114 Participants	0 Participants	0 Participants n=19 Participants	1 Participants n=4 Participants	0 Participants n=7 Participants	0 Participants n=7 Participants	18 Participants n=3 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	14 Participants n=99 Participants	4 Participants n=107 Participants	5 Participants n=206 Participants	4 Participants n=7 Participants	5 Participants n=31 Participants	5 Participants n=30 Participants	4 Participants n=3 Participants	3 Participants n=6 Participants	3 Participants n=114 Participants	12 Participants	11 Participants n=19 Participants	12 Participants n=4 Participants	10 Participants n=7 Participants	12 Participants n=7 Participants	104 Participants n=3 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants	0 Participants n=3 Participants	0 Participants n=6 Participants	0 Participants n=114 Participants	0 Participants	0 Participants n=19 Participants	0 Participants n=4 Participants	0 Participants n=7 Participants	0 Participants n=7 Participants	0 Participants n=3 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	1 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants	0 Participants n=3 Participants	0 Participants n=6 Participants	0 Participants n=114 Participants	0 Participants	0 Participants n=19 Participants	0 Participants n=4 Participants	1 Participants n=7 Participants	0 Participants n=7 Participants	2 Participants n=3 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	1 Participants n=31 Participants	0 Participants n=30 Participants	1 Participants n=3 Participants	0 Participants n=6 Participants	0 Participants n=114 Participants	0 Participants	1 Participants n=19 Participants	0 Participants n=4 Participants	0 Participants n=7 Participants	0 Participants n=7 Participants	3 Participants n=3 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	1 Participants n=31 Participants	0 Participants n=30 Participants	0 Participants n=3 Participants	0 Participants n=6 Participants	0 Participants n=114 Participants	0 Participants	0 Participants n=19 Participants	0 Participants n=4 Participants	0 Participants n=7 Participants	0 Participants n=7 Participants	1 Participants n=3 Participants
Race (NIH/OMB) Black or African American	6 Participants n=99 Participants	3 Participants n=107 Participants	2 Participants n=206 Participants	3 Participants n=7 Participants	2 Participants n=31 Participants	4 Participants n=30 Participants	2 Participants n=3 Participants	2 Participants n=6 Participants	2 Participants n=114 Participants	6 Participants	2 Participants n=19 Participants	7 Participants n=4 Participants	4 Participants n=7 Participants	5 Participants n=7 Participants	50 Participants n=3 Participants
Race (NIH/OMB) White	8 Participants n=99 Participants	3 Participants n=107 Participants	3 Participants n=206 Participants	3 Participants n=7 Participants	2 Participants n=31 Participants	2 Participants n=30 Participants	2 Participants n=3 Participants	3 Participants n=6 Participants	4 Participants n=114 Participants	6 Participants	8 Participants n=19 Participants	6 Participants n=4 Participants	5 Participants n=7 Participants	7 Participants n=7 Participants	62 Participants n=3 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants	0 Participants n=3 Participants	0 Participants n=6 Participants	0 Participants n=114 Participants	0 Participants	0 Participants n=19 Participants	0 Participants n=4 Participants	0 Participants n=7 Participants	0 Participants n=7 Participants	0 Participants n=3 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants	1 Participants n=3 Participants	1 Participants n=6 Participants	0 Participants n=114 Participants	0 Participants	0 Participants n=19 Participants	0 Participants n=4 Participants	0 Participants n=7 Participants	0 Participants n=7 Participants	4 Participants n=3 Participants

PRIMARY outcome

Timeframe: Baseline up to Day 11

Population: Safety analysis set included all participants who received study drug and had at least one postdose safety assessment.

Outcome measures

Outcome measures
Measure	Part A: E2006 Matched Placebo n=16 Participants Healthy participants received E2006-matched placebo, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 1.0 mg n=6 Participants Healthy participants received E2006 1 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 2.5 mg n=6 Participants Healthy participants received E2006 2.5 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 5 mg n=6 Participants Healthy participants received E2006 5 mg (2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 10 mg n=6 Participants Healthy participants received E2006 10 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 25 mg n=6 Participants Healthy participants received E2006 25 mg (2 capsules of 10 mg each and 2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 50 mg n=6 Participants Healthy participants received E2006 50 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 100 mg n=6 Participants Healthy participants received E2006 100 mg (2 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 200 mg n=6 Participants Healthy participants received E2006 200 mg (4 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 200 mg Healthy participants received E2006 200 mg (4 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.
Part A: Number of Participants With Treatment Emergent Adverse Events (AEs) and Treatment Emergent Serious Adverse Events (SAEs) AEs	7 Participants	1 Participants	0 Participants	1 Participants	4 Participants	2 Participants	4 Participants	2 Participants	5 Participants	—
Part A: Number of Participants With Treatment Emergent Adverse Events (AEs) and Treatment Emergent Serious Adverse Events (SAEs) SAEs	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—

PRIMARY outcome

Timeframe: Baseline up to Day 6

Population: Safety analysis set included all participants who received study drug and had at least one postdose safety assessment.

Outcome measures

Outcome measures
Measure	Part A: E2006 Matched Placebo n=16 Participants Healthy participants received E2006-matched placebo, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 1.0 mg n=6 Participants Healthy participants received E2006 1 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 2.5 mg n=6 Participants Healthy participants received E2006 2.5 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 5 mg n=6 Participants Healthy participants received E2006 5 mg (2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 10 mg n=6 Participants Healthy participants received E2006 10 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 25 mg n=6 Participants Healthy participants received E2006 25 mg (2 capsules of 10 mg each and 2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 50 mg n=6 Participants Healthy participants received E2006 50 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 100 mg n=6 Participants Healthy participants received E2006 100 mg (2 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 200 mg n=6 Participants Healthy participants received E2006 200 mg (4 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 200 mg Healthy participants received E2006 200 mg (4 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.
Part A: Number of Participants With Markedly Abnormal Laboratory Parameter Values	6 Participants	1 Participants	3 Participants	1 Participants	2 Participants	2 Participants	3 Participants	1 Participants	0 Participants	—

PRIMARY outcome

Timeframe: Baseline up to Day 11

Population: Safety analysis set included all participants who received study drug and had at least one postdose safety assessment.

Outcome measures

Outcome measures
Measure	Part A: E2006 Matched Placebo n=16 Participants Healthy participants received E2006-matched placebo, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 1.0 mg n=6 Participants Healthy participants received E2006 1 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 2.5 mg n=6 Participants Healthy participants received E2006 2.5 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 5 mg n=6 Participants Healthy participants received E2006 5 mg (2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 10 mg n=6 Participants Healthy participants received E2006 10 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 25 mg n=6 Participants Healthy participants received E2006 25 mg (2 capsules of 10 mg each and 2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 50 mg n=6 Participants Healthy participants received E2006 50 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 100 mg n=6 Participants Healthy participants received E2006 100 mg (2 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 200 mg n=6 Participants Healthy participants received E2006 200 mg (4 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 200 mg Healthy participants received E2006 200 mg (4 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.
Part A: Number of Participants With Significant Change From Baseline in Vital Sign Values	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—

PRIMARY outcome

Timeframe: Baseline up to Day 11

Population: Safety analysis set included all participants who received study drug and had at least one postdose safety assessment.

Outcome measures

Outcome measures
Measure	Part A: E2006 Matched Placebo n=16 Participants Healthy participants received E2006-matched placebo, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 1.0 mg n=6 Participants Healthy participants received E2006 1 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 2.5 mg n=6 Participants Healthy participants received E2006 2.5 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 5 mg n=6 Participants Healthy participants received E2006 5 mg (2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 10 mg n=6 Participants Healthy participants received E2006 10 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 25 mg n=6 Participants Healthy participants received E2006 25 mg (2 capsules of 10 mg each and 2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 50 mg n=6 Participants Healthy participants received E2006 50 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 100 mg n=6 Participants Healthy participants received E2006 100 mg (2 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 200 mg n=6 Participants Healthy participants received E2006 200 mg (4 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 200 mg Healthy participants received E2006 200 mg (4 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.
Part A: Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Parameter Values	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—

PRIMARY outcome

Timeframe: Baseline, Day 11

Population: Safety analysis set included all participants who received study drug and had at least one postdose safety assessment.

The C-SSRS (mapped to Columbia Classification Algorithm of Suicide Assessment \[C-CASA\]) is an interview-based rating scale to systematically assess any suicidality, any suicidal behavior, any suicidal ideation. Any suicidality: emergence of any suicidal ideation or suicidal behavior. Any suicidal behavior: when response is "yes" for any these questions- actual attempt to suicide, engaged in non-suicidal self-injurious behavior, interrupted attempt, aborted attempt, preparatory acts. Any suicidal ideation: when response is "yes" for any of these questions- wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent to suicide. Number of Participants with any suicidality has been reported for this outcome measure.

Outcome measures

Outcome measures
Measure	Part A: E2006 Matched Placebo n=16 Participants Healthy participants received E2006-matched placebo, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 1.0 mg n=6 Participants Healthy participants received E2006 1 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 2.5 mg n=6 Participants Healthy participants received E2006 2.5 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 5 mg n=6 Participants Healthy participants received E2006 5 mg (2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 10 mg n=6 Participants Healthy participants received E2006 10 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 25 mg n=6 Participants Healthy participants received E2006 25 mg (2 capsules of 10 mg each and 2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 50 mg n=6 Participants Healthy participants received E2006 50 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 100 mg n=6 Participants Healthy participants received E2006 100 mg (2 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 200 mg n=6 Participants Healthy participants received E2006 200 mg (4 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 200 mg Healthy participants received E2006 200 mg (4 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.
Part A: Number of Participants With Any Suicidality Assessed Using Columbia-Suicide Severity Rating Scale (C-SSRS) Baseline	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
Part A: Number of Participants With Any Suicidality Assessed Using Columbia-Suicide Severity Rating Scale (C-SSRS) Day 11	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—

PRIMARY outcome

Timeframe: Baseline, Day 1

Population: Pharmacodynamic (PD) analysis set included all participants who had sufficient PD data to derive at least one PD parameter.

LPS was the duration of time in minutes from lights off to the first 30 seconds of recording (epoch) of 20 consecutive epochs of non-wakefulness as measured by PSG.

Outcome measures

Outcome measures
Measure	Part A: E2006 Matched Placebo n=12 Participants Healthy participants received E2006-matched placebo, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 1.0 mg n=11 Participants Healthy participants received E2006 1 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 2.5 mg n=13 Participants Healthy participants received E2006 2.5 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 5 mg n=10 Participants Healthy participants received E2006 5 mg (2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 10 mg n=12 Participants Healthy participants received E2006 10 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 25 mg Healthy participants received E2006 25 mg (2 capsules of 10 mg each and 2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 50 mg Healthy participants received E2006 50 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 100 mg Healthy participants received E2006 100 mg (2 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 200 mg Healthy participants received E2006 200 mg (4 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 200 mg Healthy participants received E2006 200 mg (4 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.
Part B: Change From Baseline in Latency to Persistent Sleep (LPS) Assessed Using Polysomnography (PSG) Measurement at Day 1 Baseline	56.3 minutes Standard Deviation 20.5	51.8 minutes Standard Deviation 26.7	50.1 minutes Standard Deviation 35.1	55.9 minutes Standard Deviation 40.5	62.8 minutes Standard Deviation 38.3	—	—	—	—	—
Part B: Change From Baseline in Latency to Persistent Sleep (LPS) Assessed Using Polysomnography (PSG) Measurement at Day 1 Change From Baseline at Day 1	-7.17 minutes Standard Deviation 30.9	-33.1 minutes Standard Deviation 20.3	-28.1 minutes Standard Deviation 45.2	-28.8 minutes Standard Deviation 39.0	-43.9 minutes Standard Deviation 35.9	—	—	—	—	—

PRIMARY outcome

Timeframe: Baseline, Day 1

Population: PD analysis set included all participants who had sufficient PD data to derive at least one PD parameter.

TST was the duration in minutes including rapid eye movement (REM) sleep plus non-rapid eye movement (NREM) sleep during the time spent in bed.

Outcome measures

Outcome measures
Measure	Part A: E2006 Matched Placebo n=12 Participants Healthy participants received E2006-matched placebo, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 1.0 mg n=11 Participants Healthy participants received E2006 1 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 2.5 mg n=13 Participants Healthy participants received E2006 2.5 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 5 mg n=10 Participants Healthy participants received E2006 5 mg (2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 10 mg n=12 Participants Healthy participants received E2006 10 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 25 mg Healthy participants received E2006 25 mg (2 capsules of 10 mg each and 2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 50 mg Healthy participants received E2006 50 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 100 mg Healthy participants received E2006 100 mg (2 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 200 mg Healthy participants received E2006 200 mg (4 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 200 mg Healthy participants received E2006 200 mg (4 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.
Part B: Change From Baseline in Total Sleep Time (TST) Assessed Using PSG at Day 1 Baseline	335 minutes Standard Deviation 56.2	349 minutes Standard Deviation 49.9	341 minutes Standard Deviation 46.7	345 minutes Standard Deviation 60.7	342 minutes Standard Deviation 46.9	—	—	—	—	—
Part B: Change From Baseline in Total Sleep Time (TST) Assessed Using PSG at Day 1 Change From Baseline at Day 1	14.0 minutes Standard Deviation 47.6	61.3 minutes Standard Deviation 41.9	51.9 minutes Standard Deviation 60.5	61.8 minutes Standard Deviation 34.0	85.8 minutes Standard Deviation 49.9	—	—	—	—	—

PRIMARY outcome

Timeframe: Baseline, Day 1

Population: PD analysis set included all participants who had sufficient PD data to derive at least one PD parameter.

Sleep efficiency was defined as the TST divided by the time in bed (minutes) multiplied by 100. TST was the duration in minutes including REM sleep plus NREM sleep during the time spent in bed.

Outcome measures

Outcome measures
Measure	Part A: E2006 Matched Placebo n=12 Participants Healthy participants received E2006-matched placebo, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 1.0 mg n=11 Participants Healthy participants received E2006 1 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 2.5 mg n=13 Participants Healthy participants received E2006 2.5 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 5 mg n=10 Participants Healthy participants received E2006 5 mg (2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 10 mg n=12 Participants Healthy participants received E2006 10 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 25 mg Healthy participants received E2006 25 mg (2 capsules of 10 mg each and 2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 50 mg Healthy participants received E2006 50 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 100 mg Healthy participants received E2006 100 mg (2 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 200 mg Healthy participants received E2006 200 mg (4 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 200 mg Healthy participants received E2006 200 mg (4 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.
Part B: Change From Baseline in Sleep Efficiency Assessed Using PSG at Day 1 Baseline	69.8 percentage of time asleep Standard Deviation 11.7	72.7 percentage of time asleep Standard Deviation 10.4	71.1 percentage of time asleep Standard Deviation 9.72	71.9 percentage of time asleep Standard Deviation 12.6	71.3 percentage of time asleep Standard Deviation 9.77	—	—	—	—	—
Part B: Change From Baseline in Sleep Efficiency Assessed Using PSG at Day 1 Change From Baseline at Day 1	2.90 percentage of time asleep Standard Deviation 9.93	12.8 percentage of time asleep Standard Deviation 8.73	10.8 percentage of time asleep Standard Deviation 12.6	12.9 percentage of time asleep Standard Deviation 7.08	17.9 percentage of time asleep Standard Deviation 10.4	—	—	—	—	—

PRIMARY outcome

Timeframe: Baseline, Day 1

Population: PD analysis set included all participants who had sufficient PD data to derive at least one PD parameter.

WASO was defined as the duration (in minutes) of wakefulness from onset of persistent sleep to lights-on.

Outcome measures

Outcome measures
Measure	Part A: E2006 Matched Placebo n=12 Participants Healthy participants received E2006-matched placebo, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 1.0 mg n=11 Participants Healthy participants received E2006 1 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 2.5 mg n=13 Participants Healthy participants received E2006 2.5 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 5 mg n=10 Participants Healthy participants received E2006 5 mg (2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 10 mg n=12 Participants Healthy participants received E2006 10 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 25 mg Healthy participants received E2006 25 mg (2 capsules of 10 mg each and 2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 50 mg Healthy participants received E2006 50 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 100 mg Healthy participants received E2006 100 mg (2 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 200 mg Healthy participants received E2006 200 mg (4 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 200 mg Healthy participants received E2006 200 mg (4 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.
Part B: Change From Baseline in Wake After Sleep Onset (WASO) Assessed Using PSG at Day 1 Baseline	95.7 minutes Standard Deviation 52.9	85.7 minutes Standard Deviation 39.6	95.6 minutes Standard Deviation 41.5	84.7 minutes Standard Deviation 64.0	85.4 minutes Standard Deviation 20.7	—	—	—	—	—
Part B: Change From Baseline in Wake After Sleep Onset (WASO) Assessed Using PSG at Day 1 Change From Baseline at Day 1	-7.52 minutes Standard Deviation 27.3	-32.1 minutes Standard Deviation 30.7	-28.9 minutes Standard Deviation 59.0	-28.3 minutes Standard Deviation 53.6	-45.6 minutes Standard Deviation 21.1	—	—	—	—	—

PRIMARY outcome

Timeframe: Baseline, Day 1

Population: PD analysis set included all participants who had sufficient PD data to derive at least one PD parameter.

Number of awakenings was determined from LPS to lights-on. LPS was the duration of time measured from lights off to the first 30 seconds of PSG measurement recording (epoch) of 20 consecutive epochs of non-wake. An awakening was defined as a PSG recording of at least two consecutive wake epochs.

Outcome measures

Outcome measures
Measure	Part A: E2006 Matched Placebo n=12 Participants Healthy participants received E2006-matched placebo, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 1.0 mg n=11 Participants Healthy participants received E2006 1 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 2.5 mg n=13 Participants Healthy participants received E2006 2.5 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 5 mg n=10 Participants Healthy participants received E2006 5 mg (2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 10 mg n=12 Participants Healthy participants received E2006 10 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 25 mg Healthy participants received E2006 25 mg (2 capsules of 10 mg each and 2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 50 mg Healthy participants received E2006 50 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 100 mg Healthy participants received E2006 100 mg (2 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 200 mg Healthy participants received E2006 200 mg (4 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 200 mg Healthy participants received E2006 200 mg (4 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.
Part B: Change From Baseline in Number of Awakenings After Persistent Sleep (NAW) Assessed Using PSG at Day 1 Baseline	10.5 awakenings Standard Deviation 3.91	12.4 awakenings Standard Deviation 5.33	11.9 awakenings Standard Deviation 3.48	12.3 awakenings Standard Deviation 4.08	10.9 awakenings Standard Deviation 3.52	—	—	—	—	—
Part B: Change From Baseline in Number of Awakenings After Persistent Sleep (NAW) Assessed Using PSG at Day 1 Change From Baseline at Day 1	0.125 awakenings Standard Deviation 3.48	-3.45 awakenings Standard Deviation 3.08	-1.38 awakenings Standard Deviation 4.87	-0.30 awakenings Standard Deviation 6.85	0.542 awakenings Standard Deviation 4.17	—	—	—	—	—

PRIMARY outcome

Timeframe: Baseline, Day 1

Population: PD analysis set included all participants who had sufficient PD data to derive at least one PD parameter.

Sleep stages included NREM sleep and REM (dreaming) sleep. Non-REM sleep is comprised of the sum of Stage N1 (light sleep), N2 (also fairly light, with sudden increases in brain wave frequency known as sleep spindles) and N3 or slow wave sleep (deep sleep). Sleep was staged in sequential 30-second epochs.

Outcome measures

Outcome measures
Measure	Part A: E2006 Matched Placebo n=12 Participants Healthy participants received E2006-matched placebo, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 1.0 mg n=11 Participants Healthy participants received E2006 1 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 2.5 mg n=13 Participants Healthy participants received E2006 2.5 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 5 mg n=10 Participants Healthy participants received E2006 5 mg (2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 10 mg n=12 Participants Healthy participants received E2006 10 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 25 mg Healthy participants received E2006 25 mg (2 capsules of 10 mg each and 2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 50 mg Healthy participants received E2006 50 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 100 mg Healthy participants received E2006 100 mg (2 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 200 mg Healthy participants received E2006 200 mg (4 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 200 mg Healthy participants received E2006 200 mg (4 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.
Part B: Change From Baseline in Percentage of Each Sleep Stage Duration Assessed Using PSG at Day 1 Stage REM: Baseline	17.7 percentage of sleep stage duration Standard Deviation 4.86	18.4 percentage of sleep stage duration Standard Deviation 4.59	16.4 percentage of sleep stage duration Standard Deviation 3.52	15.7 percentage of sleep stage duration Standard Deviation 3.46	19.8 percentage of sleep stage duration Standard Deviation 4.93	—	—	—	—	—
Part B: Change From Baseline in Percentage of Each Sleep Stage Duration Assessed Using PSG at Day 1 Stage N1: Baseline	11.8 percentage of sleep stage duration Standard Deviation 5.74	10.3 percentage of sleep stage duration Standard Deviation 3.47	15.2 percentage of sleep stage duration Standard Deviation 5.70	11.9 percentage of sleep stage duration Standard Deviation 4.44	11.5 percentage of sleep stage duration Standard Deviation 2.54	—	—	—	—	—
Part B: Change From Baseline in Percentage of Each Sleep Stage Duration Assessed Using PSG at Day 1 Stage N1: Change at Day 1	0.00429 percentage of sleep stage duration Standard Deviation 5.29	-0.715 percentage of sleep stage duration Standard Deviation 5.02	-4.28 percentage of sleep stage duration Standard Deviation 6.11	2.19 percentage of sleep stage duration Standard Deviation 4.92	-2.67 percentage of sleep stage duration Standard Deviation 2.49	—	—	—	—	—
Part B: Change From Baseline in Percentage of Each Sleep Stage Duration Assessed Using PSG at Day 1 Stage N2: Baseline	56.5 percentage of sleep stage duration Standard Deviation 7.73	56.3 percentage of sleep stage duration Standard Deviation 6.70	57.5 percentage of sleep stage duration Standard Deviation 10.9	60.6 percentage of sleep stage duration Standard Deviation 12.0	51.5 percentage of sleep stage duration Standard Deviation 6.61	—	—	—	—	—
Part B: Change From Baseline in Percentage of Each Sleep Stage Duration Assessed Using PSG at Day 1 Stage N2: Change at Day 1	0.390 percentage of sleep stage duration Standard Deviation 4.64	-0.316 percentage of sleep stage duration Standard Deviation 4.96	-0.306 percentage of sleep stage duration Standard Deviation 7.49	-3.12 percentage of sleep stage duration Standard Deviation 9.36	-2.73 percentage of sleep stage duration Standard Deviation 5.77	—	—	—	—	—
Part B: Change From Baseline in Percentage of Each Sleep Stage Duration Assessed Using PSG at Day 1 Stage N3/Slow Wave Sleep: Baseline	14.0 percentage of sleep stage duration Standard Deviation 8.74	15.0 percentage of sleep stage duration Standard Deviation 9.77	10.9 percentage of sleep stage duration Standard Deviation 9.78	11.8 percentage of sleep stage duration Standard Deviation 12.1	17.2 percentage of sleep stage duration Standard Deviation 4.75	—	—	—	—	—
Part B: Change From Baseline in Percentage of Each Sleep Stage Duration Assessed Using PSG at Day 1 Stage N3/Slow Wave Sleep : Change at Day 1	0.0613 percentage of sleep stage duration Standard Deviation 2.90	2.15 percentage of sleep stage duration Standard Deviation 3.77	-0.0852 percentage of sleep stage duration Standard Deviation 6.10	1.01 percentage of sleep stage duration Standard Deviation 8.55	-0.42 percentage of sleep stage duration Standard Deviation 3.28	—	—	—	—	—
Part B: Change From Baseline in Percentage of Each Sleep Stage Duration Assessed Using PSG at Day 1 Stage REM: Change at Day 1	-0.455 percentage of sleep stage duration Standard Deviation 3.58	-1.12 percentage of sleep stage duration Standard Deviation 4.13	4.67 percentage of sleep stage duration Standard Deviation 6.54	-0.0712 percentage of sleep stage duration Standard Deviation 7.07	5.82 percentage of sleep stage duration Standard Deviation 5.27	—	—	—	—	—

PRIMARY outcome

Timeframe: Baseline, Day 1

Population: PD analysis set included all participants who had sufficient PD data to derive at least one PD parameter.

Sleep stages included NREM sleep and REM (dreaming) sleep. Non-REM sleep is comprised of the sum of Stage N1 (light sleep), N2 (also fairly light, with sudden increases in brain wave frequency known as sleep spindles) and N3 or slow wave sleep (deep sleep). Sleep was staged in sequential 30-second epochs.

Outcome measures

Outcome measures
Measure	Part A: E2006 Matched Placebo n=12 Participants Healthy participants received E2006-matched placebo, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 1.0 mg n=11 Participants Healthy participants received E2006 1 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 2.5 mg n=13 Participants Healthy participants received E2006 2.5 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 5 mg n=10 Participants Healthy participants received E2006 5 mg (2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 10 mg n=12 Participants Healthy participants received E2006 10 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 25 mg Healthy participants received E2006 25 mg (2 capsules of 10 mg each and 2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 50 mg Healthy participants received E2006 50 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 100 mg Healthy participants received E2006 100 mg (2 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 200 mg Healthy participants received E2006 200 mg (4 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 200 mg Healthy participants received E2006 200 mg (4 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.
Part B: Change From Baseline in Duration (in Minutes) of Each Sleep Stage Assessed Using PSG at Day 1 Stage N1: Baseline	37.8 minutes Standard Deviation 16.6	35.1 minutes Standard Deviation 11.3	50.1 minutes Standard Deviation 15.5	40.7 minutes Standard Deviation 17.3	38.9 minutes Standard Deviation 11.0	—	—	—	—	—
Part B: Change From Baseline in Duration (in Minutes) of Each Sleep Stage Assessed Using PSG at Day 1 Stage N1: Change at Day 1	2.38 minutes Standard Deviation 17.8	3.41 minutes Standard Deviation 17.4	-7.65 minutes Standard Deviation 15.0	14.7 minutes Standard Deviation 19.9	-1.35 minutes Standard Deviation 11.1	—	—	—	—	—
Part B: Change From Baseline in Duration (in Minutes) of Each Sleep Stage Assessed Using PSG at Day 1 Stage N2: Baseline	190 minutes Standard Deviation 39.4	195 minutes Standard Deviation 27.7	198 minutes Standard Deviation 52.7	212 minutes Standard Deviation 63.6	175 minutes Standard Deviation 29.2	—	—	—	—	—
Part B: Change From Baseline in Duration (in Minutes) of Each Sleep Stage Assessed Using PSG at Day 1 Stage N2: Change at Day 1	10.4 minutes Standard Deviation 34.3	34.4 minutes Standard Deviation 33.9	29.6 minutes Standard Deviation 52.3	21.5 minutes Standard Deviation 38.8	33.6 minutes Standard Deviation 36.6	—	—	—	—	—
Part B: Change From Baseline in Duration (in Minutes) of Each Sleep Stage Assessed Using PSG at Day 1 Stage N3/Slow Wave Sleep: Baseline	47.7 minutes Standard Deviation 33.2	53.4 minutes Standard Deviation 35.2	36.5 minutes Standard Deviation 32.1	38.3 minutes Standard Deviation 37.8	59.1 minutes Standard Deviation 18.2	—	—	—	—	—
Part B: Change From Baseline in Duration (in Minutes) of Each Sleep Stage Assessed Using PSG at Day 1 Stage N3/Slow Wave Sleep: Change at Day 1	1.94 minutes Standard Deviation 12.7	16.3 minutes Standard Deviation 17.4	3.73 minutes Standard Deviation 18.3	14.9 minutes Standard Deviation 28.8	12.7 minutes Standard Deviation 11.3	—	—	—	—	—
Part B: Change From Baseline in Duration (in Minutes) of Each Sleep Stage Assessed Using PSG at Day 1 Stage REM: Baseline	59.4 minutes Standard Deviation 19.3	65.3 minutes Standard Deviation 20.0	56.7 minutes Standard Deviation 15.7	54.0 minutes Standard Deviation 14.0	68.8 minutes Standard Deviation 19.6	—	—	—	—	—
Part B: Change From Baseline in Duration (in Minutes) of Each Sleep Stage Assessed Using PSG at Day 1 Stage REM: Change at Day 1	-0.729 minutes Standard Deviation 13.3	7.14 minutes Standard Deviation 19.2	26.3 minutes Standard Deviation 31.8	10.7 minutes Standard Deviation 29.5	40.8 minutes Standard Deviation 21.7	—	—	—	—	—

PRIMARY outcome

Timeframe: Baseline, Day 1

Population: PD analysis set included all participants who had sufficient PD data to derive at least one PD parameter.

Sleep stages included NREM sleep and REM (dreaming) sleep. Non-REM sleep is comprised of the sum of Stage N1 (light sleep), N2 (also fairly light, with sudden increases in brain wave frequency known as sleep spindles) and N3 or slow wave sleep (deep sleep). Sleep was staged in sequential 30-second epochs.

Outcome measures

Outcome measures
Measure	Part A: E2006 Matched Placebo n=12 Participants Healthy participants received E2006-matched placebo, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 1.0 mg n=11 Participants Healthy participants received E2006 1 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 2.5 mg n=13 Participants Healthy participants received E2006 2.5 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 5 mg n=10 Participants Healthy participants received E2006 5 mg (2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 10 mg n=12 Participants Healthy participants received E2006 10 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 25 mg Healthy participants received E2006 25 mg (2 capsules of 10 mg each and 2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 50 mg Healthy participants received E2006 50 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 100 mg Healthy participants received E2006 100 mg (2 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 200 mg Healthy participants received E2006 200 mg (4 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 200 mg Healthy participants received E2006 200 mg (4 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.
Part B: Change From Baseline in Mean Total Number of Shift in Sleep Stages Assessed Using PSG at Day 1 Baseline	167 stage shift Standard Deviation 22.3	168 stage shift Standard Deviation 35.5	174 stage shift Standard Deviation 42.2	188 stage shift Standard Deviation 45.6	153 stage shift Standard Deviation 36.7	—	—	—	—	—
Part B: Change From Baseline in Mean Total Number of Shift in Sleep Stages Assessed Using PSG at Day 1 Change From Baseline at Day 1	0.250 stage shift Standard Deviation 35.7	4.18 stage shift Standard Deviation 41.2	-16.3 stage shift Standard Deviation 30.4	14.4 stage shift Standard Deviation 53.1	14.0 stage shift Standard Deviation 28.1	—	—	—	—	—

PRIMARY outcome

Timeframe: Day 1, Day 6

Population: PD analysis set included all participants who had sufficient PD data to derive at least one PD parameter.

Participants were asked to answer the following question using Waketime Questionnaire: How long did you sleep last night, number of awakening after falling asleep, time to fall asleep last night, time spent awake after falling asleep, rate quality of your sleep (using Likert scale, ranged from 0 = very sound or restful, to 4 = very restless where lower score indicates better outcome). The primary purpose of the Waketime Questionnaire was to confirm anticipated reports of poor sleep. In this outcome measure, data for question "How long did you sleep last night" has been reported.

Outcome measures

Outcome measures
Measure	Part A: E2006 Matched Placebo n=12 Participants Healthy participants received E2006-matched placebo, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 1.0 mg n=11 Participants Healthy participants received E2006 1 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 2.5 mg n=13 Participants Healthy participants received E2006 2.5 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 5 mg n=10 Participants Healthy participants received E2006 5 mg (2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 10 mg n=12 Participants Healthy participants received E2006 10 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 25 mg Healthy participants received E2006 25 mg (2 capsules of 10 mg each and 2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 50 mg Healthy participants received E2006 50 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 100 mg Healthy participants received E2006 100 mg (2 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 200 mg Healthy participants received E2006 200 mg (4 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 200 mg Healthy participants received E2006 200 mg (4 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.
Part B: Change From Day 1 in Waketime Questionnaire Parameters: How Long Did You Sleep Last Night at Day 6 Day 1	302.1 minutes Standard Deviation 82.39	292.3 minutes Standard Deviation 61.21	298.8 minutes Standard Deviation 106.45	302.5 minutes Standard Deviation 71.70	276.3 minutes Standard Deviation 82.77	—	—	—	—	—
Part B: Change From Day 1 in Waketime Questionnaire Parameters: How Long Did You Sleep Last Night at Day 6 Change From Day 1 at Day 6	-3.3 minutes Standard Deviation 74.66	12.7 minutes Standard Deviation 55.11	42.4 minutes Standard Deviation 89.08	-41.5 minutes Standard Deviation 87.24	20.0 minutes Standard Deviation 60.11	—	—	—	—	—

PRIMARY outcome

Timeframe: Day 1, Day 6

Population: PD analysis set included all participants who had sufficient PD data to derive at least one PD parameter.

Participants were asked to answer the following question using Waketime Questionnaire: How long did you sleep last night, number of awakening after falling asleep, time to fall asleep last night, time spent awake after falling asleep, rate quality of your sleep (using Likert scale, ranged from 0 = very sound or restful, to 4 = very restless where lower score indicates better outcome). The primary purpose of the Waketime Questionnaire was to confirm anticipated reports of poor sleep. In this outcome measure, data for question "Time to fall asleep last night" has been reported.

Outcome measures

Outcome measures
Measure	Part A: E2006 Matched Placebo n=12 Participants Healthy participants received E2006-matched placebo, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 1.0 mg n=11 Participants Healthy participants received E2006 1 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 2.5 mg n=13 Participants Healthy participants received E2006 2.5 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 5 mg n=10 Participants Healthy participants received E2006 5 mg (2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 10 mg n=12 Participants Healthy participants received E2006 10 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 25 mg Healthy participants received E2006 25 mg (2 capsules of 10 mg each and 2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 50 mg Healthy participants received E2006 50 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 100 mg Healthy participants received E2006 100 mg (2 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 200 mg Healthy participants received E2006 200 mg (4 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 200 mg Healthy participants received E2006 200 mg (4 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.
Part B: Change From Day 1 in Waketime Questionnaire Parameters: Time to Fall Asleep Last Night at Day 6 Day 1	70.8 minutes Standard Deviation 22.55	67.3 minutes Standard Deviation 30.36	72.2 minutes Standard Deviation 51.99	82.5 minutes Standard Deviation 61.02	108.1 minutes Standard Deviation 65.00	—	—	—	—	—
Part B: Change From Day 1 in Waketime Questionnaire Parameters: Time to Fall Asleep Last Night at Day 6 Change From Day 1 at Day 6	8.3 minutes Standard Deviation 36.33	9.1 minutes Standard Deviation 28.09	-3.8 minutes Standard Deviation 31.37	46.5 minutes Standard Deviation 76.63	-13.7 minutes Standard Deviation 42.57	—	—	—	—	—

PRIMARY outcome

Timeframe: Day 1, Day 6

Population: PD analysis set included all participants who had sufficient PD data to derive at least one PD parameter.

Participants were asked to answer the following question using Waketime Questionnaire: How long did you sleep last night, number of awakening after falling asleep, time to fall asleep last night, time spent awake after falling asleep, rate quality of your sleep (using Likert scale, ranged from 0 = very sound or restful, to 4 = very restless where lower score indicates better outcome). The primary purpose of the Waketime Questionnaire was to confirm anticipated reports of poor sleep. In this outcome measure, data for question "Number of awakening after falling asleep" has been reported.

Outcome measures

Outcome measures
Measure	Part A: E2006 Matched Placebo n=12 Participants Healthy participants received E2006-matched placebo, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 1.0 mg n=11 Participants Healthy participants received E2006 1 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 2.5 mg n=13 Participants Healthy participants received E2006 2.5 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 5 mg n=10 Participants Healthy participants received E2006 5 mg (2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 10 mg n=12 Participants Healthy participants received E2006 10 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 25 mg Healthy participants received E2006 25 mg (2 capsules of 10 mg each and 2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 50 mg Healthy participants received E2006 50 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 100 mg Healthy participants received E2006 100 mg (2 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 200 mg Healthy participants received E2006 200 mg (4 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 200 mg Healthy participants received E2006 200 mg (4 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.
Part B: Change From Day 1 in Waketime Questionnaire Parameters: Number of Awakening After Falling Asleep at Day 6 Day 1	2.7 number of awakenings Standard Deviation 1.30	2.7 number of awakenings Standard Deviation 1.42	2.8 number of awakenings Standard Deviation 1.30	2.7 number of awakenings Standard Deviation 1.42	3.6 number of awakenings Standard Deviation 1.24	—	—	—	—	—
Part B: Change From Day 1 in Waketime Questionnaire Parameters: Number of Awakening After Falling Asleep at Day 6 Change From Day 1 at Day 6	-0.1 number of awakenings Standard Deviation 1.16	-0.3 number of awakenings Standard Deviation 1.10	-0.6 number of awakenings Standard Deviation 1.39	0.7 number of awakenings Standard Deviation 2.31	0.3 number of awakenings Standard Deviation 0.97	—	—	—	—	—

PRIMARY outcome

Timeframe: Day 1, Day 6

Population: PD analysis set included all participants who had sufficient PD data to derive at least one PD parameter.

Participants were asked to answer the following question using Waketime Questionnaire: How long did you sleep last night, number of awakening after falling asleep, time to fall asleep last night, time spent awake after falling asleep, rate quality of your sleep (using Likert scale, ranged from 0 = very sound or restful, to 4 = very restless where lower score indicates better outcome). The primary purpose of the Waketime Questionnaire was to confirm anticipated reports of poor sleep. In this outcome measure, data for question "Time spent awake after falling asleep" has been reported.

Outcome measures

Outcome measures
Measure	Part A: E2006 Matched Placebo n=12 Participants Healthy participants received E2006-matched placebo, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 1.0 mg n=11 Participants Healthy participants received E2006 1 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 2.5 mg n=13 Participants Healthy participants received E2006 2.5 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 5 mg n=10 Participants Healthy participants received E2006 5 mg (2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 10 mg n=12 Participants Healthy participants received E2006 10 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 25 mg Healthy participants received E2006 25 mg (2 capsules of 10 mg each and 2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 50 mg Healthy participants received E2006 50 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 100 mg Healthy participants received E2006 100 mg (2 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 200 mg Healthy participants received E2006 200 mg (4 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 200 mg Healthy participants received E2006 200 mg (4 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.
Part B: Change From Day 1 in Waketime Questionnaire Parameters: Time Spent Awake After Falling Asleep at Day 6 Day 1	133.8 minutes Standard Deviation 115.76	101.8 minutes Standard Deviation 76.36	82.3 minutes Standard Deviation 46.31	102.0 minutes Standard Deviation 68.56	128.8 minutes Standard Deviation 88.30	—	—	—	—	—
Part B: Change From Day 1 in Waketime Questionnaire Parameters: Time Spent Awake After Falling Asleep at Day 6 Change From Day 1 at Day 6	-27.9 minutes Standard Deviation 136.39	-5.5 minutes Standard Deviation 55.70	-3.7 minutes Standard Deviation 54.03	46.8 minutes Standard Deviation 140.47	10.7 minutes Standard Deviation 93.91	—	—	—	—	—

PRIMARY outcome

Timeframe: Day 1, Day 6

Population: PD analysis set included all participants who had sufficient PD data to derive at least one PD parameter.

Participants were asked to answer the following question using Waketime Questionnaire: How long did you sleep last night, number of awakening after falling asleep, time to fall asleep last night, time spent awake after falling asleep, rate quality of your sleep (using Likert scale, ranged from 0 = very sound or restful, to 4 = very restless where lower score indicates better outcome). The primary purpose of the Waketime Questionnaire was to confirm anticipated reports of poor sleep. In this outcome measure, data for question "Rate quality of your sleep" has been reported.

Outcome measures

Outcome measures
Measure	Part A: E2006 Matched Placebo n=12 Participants Healthy participants received E2006-matched placebo, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 1.0 mg n=11 Participants Healthy participants received E2006 1 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 2.5 mg n=13 Participants Healthy participants received E2006 2.5 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 5 mg n=10 Participants Healthy participants received E2006 5 mg (2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 10 mg n=12 Participants Healthy participants received E2006 10 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 25 mg Healthy participants received E2006 25 mg (2 capsules of 10 mg each and 2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 50 mg Healthy participants received E2006 50 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 100 mg Healthy participants received E2006 100 mg (2 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 200 mg Healthy participants received E2006 200 mg (4 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 200 mg Healthy participants received E2006 200 mg (4 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.
Part B: Change From Day 1 in Waketime Questionnaire Parameters: Rate Quality of Your Sleep at Day 6 Day 1	2.8 score on a scale Standard Deviation 0.72	3.1 score on a scale Standard Deviation 0.83	2.6 score on a scale Standard Deviation 0.65	2.6 score on a scale Standard Deviation 0.70	2.8 score on a scale Standard Deviation 0.75	—	—	—	—	—
Part B: Change From Day 1 in Waketime Questionnaire Parameters: Rate Quality of Your Sleep at Day 6 Change From Day 1 at Day 6	-0.6 score on a scale Standard Deviation 0.67	-0.5 score on a scale Standard Deviation 0.93	-0.5 score on a scale Standard Deviation 0.78	0.2 score on a scale Standard Deviation 0.92	-0.4 score on a scale Standard Deviation 1.00	—	—	—	—	—

PRIMARY outcome

Timeframe: Day 1 (Pre-dose), Day 6

Population: PD analysis set included all participants who had sufficient PD data to derive at least one PD parameter.

DSST is a cognitive test designed to assess psychomotor speed of performance requiring visual perception, spatial decision-making, and motor skills. It consists of 133 digits and requires the participant to substitute each digit with a simple symbol in a 90-second period. Each correct symbol is counted, and the total score ranges from 0 (less than cognitive functioning) to 133 (greater than cognitive functioning) as a description of DSST. An increase in score represents an improvement in an integrated measure of cognitive function.

Outcome measures

Outcome measures
Measure	Part A: E2006 Matched Placebo n=12 Participants Healthy participants received E2006-matched placebo, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 1.0 mg n=11 Participants Healthy participants received E2006 1 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 2.5 mg n=13 Participants Healthy participants received E2006 2.5 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 5 mg n=10 Participants Healthy participants received E2006 5 mg (2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 10 mg n=12 Participants Healthy participants received E2006 10 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 25 mg Healthy participants received E2006 25 mg (2 capsules of 10 mg each and 2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 50 mg Healthy participants received E2006 50 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 100 mg Healthy participants received E2006 100 mg (2 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 200 mg Healthy participants received E2006 200 mg (4 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 200 mg Healthy participants received E2006 200 mg (4 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.
Part B: Change From Day 1 (Pre-dose) in Digit Symbol Substitution Test (DSST) Score at Day 6 Day 1 (Pre-dose)	53.0 score on a scale Standard Deviation 9.56	50.7 score on a scale Standard Deviation 11.64	48.2 score on a scale Standard Deviation 10.80	51.0 score on a scale Standard Deviation 6.48	49.5 score on a scale Standard Deviation 11.87	—	—	—	—	—
Part B: Change From Day 1 (Pre-dose) in Digit Symbol Substitution Test (DSST) Score at Day 6 Change From Day 1 (Pre-dose) at Day 6	9.8 score on a scale Standard Deviation 15.15	10.5 score on a scale Standard Deviation 14.44	14.3 score on a scale Standard Deviation 13.34	8.3 score on a scale Standard Deviation 15.33	11.7 score on a scale Standard Deviation 20.67	—	—	—	—	—

PRIMARY outcome

Timeframe: Day 1 (Pre-dose), Day 6

Population: PD analysis set included all participants who had sufficient PD data to derive at least one PD parameter. Here "number analyzed" signifies participants who were evaluable for this outcome measure at given time points.

PVT, a computer-based test, is a chronometric measure of an individual's reaction to specified small changes in a labile environment. Participants were instructed to respond to a digital signal on a computer terminal by pressing a key. Errors of omission and commission are recorded. When a participant did not respond to the PVT signal within 500 msec, it was termed a lapse. The higher the number of lapses the greater the impairment.

Outcome measures

Outcome measures
Measure	Part A: E2006 Matched Placebo n=12 Participants Healthy participants received E2006-matched placebo, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 1.0 mg n=11 Participants Healthy participants received E2006 1 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 2.5 mg n=13 Participants Healthy participants received E2006 2.5 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 5 mg n=10 Participants Healthy participants received E2006 5 mg (2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 10 mg n=12 Participants Healthy participants received E2006 10 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 25 mg Healthy participants received E2006 25 mg (2 capsules of 10 mg each and 2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 50 mg Healthy participants received E2006 50 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 100 mg Healthy participants received E2006 100 mg (2 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 200 mg Healthy participants received E2006 200 mg (4 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 200 mg Healthy participants received E2006 200 mg (4 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.
Part B: Change From Day 1 (Pre-dose) in Number of Lapses of Greater Than (>) 500- Milliseconds (Msec) Assessed by Psychomotor Vigilance Test (PVT) at Day 6 Day 1 (Pre-dose)	2.3 lapses Standard Deviation 3.67	3.0 lapses Standard Deviation 2.86	4.1 lapses Standard Deviation 7.57	4.4 lapses Standard Deviation 4.22	5.2 lapses Standard Deviation 12.00	—	—	—	—	—
Part B: Change From Day 1 (Pre-dose) in Number of Lapses of Greater Than (>) 500- Milliseconds (Msec) Assessed by Psychomotor Vigilance Test (PVT) at Day 6 Change From Day 1 (Pre-dose) at Day 6	0.3 lapses Standard Deviation 2.49	2.3 lapses Standard Deviation 6.84	0.9 lapses Standard Deviation 5.33	-1.4 lapses Standard Deviation 3.66	-1.2 lapses Standard Deviation 9.57	—	—	—	—	—

PRIMARY outcome

Timeframe: Day 1 (Pre-dose), Day 6

Population: PD analysis set included all participants who had sufficient PD data to derive at least one PD parameter.

KSS is a 9-point scale, on which the participant has to mark his or her sleepiness during the previous 10 minutes. The scale ranges from 1, which indicates "extremely alert", to 9, which indicates "extremely sleepy, can't stay awake". Higher numbers indicating sleepier and lower numbers more alert.

Outcome measures

Outcome measures
Measure	Part A: E2006 Matched Placebo n=12 Participants Healthy participants received E2006-matched placebo, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 1.0 mg n=11 Participants Healthy participants received E2006 1 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 2.5 mg n=13 Participants Healthy participants received E2006 2.5 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 5 mg n=10 Participants Healthy participants received E2006 5 mg (2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 10 mg n=12 Participants Healthy participants received E2006 10 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 25 mg Healthy participants received E2006 25 mg (2 capsules of 10 mg each and 2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 50 mg Healthy participants received E2006 50 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 100 mg Healthy participants received E2006 100 mg (2 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 200 mg Healthy participants received E2006 200 mg (4 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 200 mg Healthy participants received E2006 200 mg (4 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.
Part B: Change From Day 1 (Pre-dose) in Score on Karolinska Sleepiness Scale (KSS) at Day 6 Day 1 (Pre-dose)	4.4 score on a scale Standard Deviation 1.83	3.8 score on a scale Standard Deviation 2.04	4.0 score on a scale Standard Deviation 2.20	4.8 score on a scale Standard Deviation 2.20	5.5 score on a scale Standard Deviation 1.93	—	—	—	—	—
Part B: Change From Day 1 (Pre-dose) in Score on Karolinska Sleepiness Scale (KSS) at Day 6 Change From Day 1 (Pre-dose) at Day 6	-0.4 score on a scale Standard Deviation 1.68	1.0 score on a scale Standard Deviation 1.41	0.2 score on a scale Standard Deviation 1.34	0.3 score on a scale Standard Deviation 1.95	-0.7 score on a scale Standard Deviation 2.27	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 1: Pre-dose, up to 240 hours post-dose

Population: Pharmacokinetic (PK) analysis set included all participants who had sufficient PK data to derive at least one PK parameter. PK parameters for Part B were not analyzed due to change in planned analysis.

Outcome measures

Outcome measures
Measure	Part A: E2006 Matched Placebo n=6 Participants Healthy participants received E2006-matched placebo, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 1.0 mg n=6 Participants Healthy participants received E2006 1 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 2.5 mg n=6 Participants Healthy participants received E2006 2.5 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 5 mg n=6 Participants Healthy participants received E2006 5 mg (2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 10 mg n=6 Participants Healthy participants received E2006 10 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 25 mg n=6 Participants Healthy participants received E2006 25 mg (2 capsules of 10 mg each and 2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 50 mg n=6 Participants Healthy participants received E2006 50 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 100 mg n=6 Participants Healthy participants received E2006 100 mg (2 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 200 mg Healthy participants received E2006 200 mg (4 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 200 mg Healthy participants received E2006 200 mg (4 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.
Part A: Maximum Plasma Concentration (Cmax) of E2006	5.15 nanogram per milliliter (ng/mL) Geometric Coefficient of Variation 27.1	14.9 nanogram per milliliter (ng/mL) Geometric Coefficient of Variation 43.0	22.3 nanogram per milliliter (ng/mL) Geometric Coefficient of Variation 19.1	32.0 nanogram per milliliter (ng/mL) Geometric Coefficient of Variation 57.3	107 nanogram per milliliter (ng/mL) Geometric Coefficient of Variation 20.3	161 nanogram per milliliter (ng/mL) Geometric Coefficient of Variation 32.9	242 nanogram per milliliter (ng/mL) Geometric Coefficient of Variation 47.0	429 nanogram per milliliter (ng/mL) Geometric Coefficient of Variation 12.2	—	—

SECONDARY outcome

Timeframe: Day 1: Pre-dose, up to 240 hours post-dose

Population: PK analysis set included all participants who had sufficient PK data to derive at least one PK parameter. PK parameters for Part B were not analyzed due to change in planned analysis.

Outcome measures

Outcome measures
Measure	Part A: E2006 Matched Placebo n=6 Participants Healthy participants received E2006-matched placebo, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 1.0 mg n=6 Participants Healthy participants received E2006 1 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 2.5 mg n=6 Participants Healthy participants received E2006 2.5 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 5 mg n=6 Participants Healthy participants received E2006 5 mg (2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 10 mg n=6 Participants Healthy participants received E2006 10 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 25 mg n=6 Participants Healthy participants received E2006 25 mg (2 capsules of 10 mg each and 2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 50 mg n=6 Participants Healthy participants received E2006 50 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 100 mg n=6 Participants Healthy participants received E2006 100 mg (2 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 200 mg Healthy participants received E2006 200 mg (4 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 200 mg Healthy participants received E2006 200 mg (4 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.
Part A: Time to Reach Maximum Plasma Concentration (Tmax) of E2006	1.000 hours Interval 1.0 to 1.08	1.010 hours Interval 1.0 to 3.0	1.550 hours Interval 0.92 to 3.0	1.000 hours Interval 0.57 to 2.0	2.010 hours Interval 1.0 to 3.0	2.525 hours Interval 1.0 to 3.08	3.000 hours Interval 3.0 to 5.0	3.000 hours Interval 1.0 to 9.0	—	—

SECONDARY outcome

Timeframe: Day 1: Pre-dose, up to 240 hours post-dose

Population: PK analysis set included all participants who had sufficient PK data to derive at least one PK parameter. PK parameter for Part B were not analyzed due to change in planned analysis.

Outcome measures

Outcome measures
Measure	Part A: E2006 Matched Placebo n=6 Participants Healthy participants received E2006-matched placebo, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 1.0 mg n=6 Participants Healthy participants received E2006 1 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 2.5 mg n=6 Participants Healthy participants received E2006 2.5 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 5 mg n=6 Participants Healthy participants received E2006 5 mg (2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 10 mg n=6 Participants Healthy participants received E2006 10 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 25 mg n=6 Participants Healthy participants received E2006 25 mg (2 capsules of 10 mg each and 2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 50 mg n=6 Participants Healthy participants received E2006 50 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 100 mg n=6 Participants Healthy participants received E2006 100 mg (2 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 200 mg Healthy participants received E2006 200 mg (4 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 200 mg Healthy participants received E2006 200 mg (4 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.
Part A: Area Under the Plasma Concentration-time Curve From Time Zero to 24 Hours (AUC0-24) of E2006	17.0 nanogram hour per milliliter (ng*h/mL) Geometric Coefficient of Variation 17.5	53.8 nanogram hour per milliliter (ng*h/mL) Geometric Coefficient of Variation 36.4	93.2 nanogram hour per milliliter (ng*h/mL) Geometric Coefficient of Variation 18.9	150 nanogram hour per milliliter (ng*h/mL) Geometric Coefficient of Variation 38.9	648 nanogram hour per milliliter (ng*h/mL) Geometric Coefficient of Variation 15.4	1060 nanogram hour per milliliter (ng*h/mL) Geometric Coefficient of Variation 33.0	1850 nanogram hour per milliliter (ng*h/mL) Geometric Coefficient of Variation 33.8	3970 nanogram hour per milliliter (ng*h/mL) Geometric Coefficient of Variation 24.8	—	—

SECONDARY outcome

Timeframe: Day 1: Pre-dose, up to 240 hours post-dose

Population: PK analysis set included all participants who had sufficient PK data to derive at least one PK parameter. PK parameters for Part B were not analyzed due to change in planned analysis.

Outcome measures

Outcome measures
Measure	Part A: E2006 Matched Placebo n=6 Participants Healthy participants received E2006-matched placebo, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 1.0 mg n=6 Participants Healthy participants received E2006 1 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 2.5 mg n=6 Participants Healthy participants received E2006 2.5 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 5 mg n=6 Participants Healthy participants received E2006 5 mg (2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 10 mg n=6 Participants Healthy participants received E2006 10 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 25 mg n=6 Participants Healthy participants received E2006 25 mg (2 capsules of 10 mg each and 2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 50 mg n=6 Participants Healthy participants received E2006 50 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 100 mg n=6 Participants Healthy participants received E2006 100 mg (2 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 200 mg Healthy participants received E2006 200 mg (4 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 200 mg Healthy participants received E2006 200 mg (4 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.
Part A: Area Under the Plasma Concentration-time Curve From Time Zero to t Hours (AUC0-t) of E2006	18.4 ng*h/mL Geometric Coefficient of Variation 29.9	74.4 ng*h/mL Geometric Coefficient of Variation 45.9	126 ng*h/mL Geometric Coefficient of Variation 18.7	274 ng*h/mL Geometric Coefficient of Variation 30.4	1390 ng*h/mL Geometric Coefficient of Variation 31.3	1960 ng*h/mL Geometric Coefficient of Variation 38.5	4300 ng*h/mL Geometric Coefficient of Variation 35.1	9290 ng*h/mL Geometric Coefficient of Variation 39.5	—	—

SECONDARY outcome

Timeframe: Day 1: Pre-dose, up to 240 hours post-dose

Population: PK analysis set included all participants who had sufficient PK data to derive at least one PK parameter. PK parameters for Part B were not analyzed due to change in planned analysis. Here "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.

Outcome measures

Outcome measures
Measure	Part A: E2006 Matched Placebo n=5 Participants Healthy participants received E2006-matched placebo, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 1.0 mg n=4 Participants Healthy participants received E2006 1 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 2.5 mg n=5 Participants Healthy participants received E2006 2.5 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 5 mg n=6 Participants Healthy participants received E2006 5 mg (2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 10 mg n=6 Participants Healthy participants received E2006 10 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 25 mg n=6 Participants Healthy participants received E2006 25 mg (2 capsules of 10 mg each and 2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 50 mg n=6 Participants Healthy participants received E2006 50 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 100 mg n=6 Participants Healthy participants received E2006 100 mg (2 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 200 mg Healthy participants received E2006 200 mg (4 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 200 mg Healthy participants received E2006 200 mg (4 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.
Part A: Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of E2006	19.5 ng*h/mL Geometric Coefficient of Variation 19.8	72.3 ng*h/mL Geometric Coefficient of Variation 54.3	146 ng*h/mL Geometric Coefficient of Variation 20.9	299 ng*h/mL Geometric Coefficient of Variation 31.7	1470 ng*h/mL Geometric Coefficient of Variation 33.7	2020 ng*h/mL Geometric Coefficient of Variation 40.3	4520 ng*h/mL Geometric Coefficient of Variation 36.8	9910 ng*h/mL Geometric Coefficient of Variation 39.5	—	—

SECONDARY outcome

Timeframe: Day 1: Pre-dose, up to 240 hours post-dose

Population: PK analysis set included all participants who had sufficient PK data to derive at least one PK parameter. PK parameters for Part B were not analyzed due to change in planned analysis.

Outcome measures

Outcome measures
Measure	Part A: E2006 Matched Placebo n=6 Participants Healthy participants received E2006-matched placebo, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 1.0 mg n=6 Participants Healthy participants received E2006 1 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 2.5 mg n=6 Participants Healthy participants received E2006 2.5 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 5 mg n=6 Participants Healthy participants received E2006 5 mg (2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 10 mg n=6 Participants Healthy participants received E2006 10 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 25 mg n=6 Participants Healthy participants received E2006 25 mg (2 capsules of 10 mg each and 2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 50 mg n=6 Participants Healthy participants received E2006 50 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 100 mg n=6 Participants Healthy participants received E2006 100 mg (2 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 200 mg Healthy participants received E2006 200 mg (4 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 200 mg Healthy participants received E2006 200 mg (4 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.
Part A: Terminal Half-life (t1/2) of E2006 in Plasma	12.700 hours Interval 9.12 to 65.1	30.100 hours Interval 14.5 to 50.7	31.350 hours Interval 26.2 to 42.8	56.150 hours Interval 34.9 to 72.2	65.500 hours Interval 53.6 to 71.6	51.850 hours Interval 36.1 to 72.8	59.750 hours Interval 50.5 to 73.0	65.200 hours Interval 27.0 to 75.8	—	—

SECONDARY outcome

Timeframe: Day 1: Pre-dose, up to 240 hours post-dose

Population: PK analysis set included all participants who had sufficient PK data to derive at least one PK parameter. PK parameters for Part B were not analyzed due to change in planned analysis.

Outcome measures

Outcome measures
Measure	Part A: E2006 Matched Placebo n=6 Participants Healthy participants received E2006-matched placebo, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 1.0 mg n=6 Participants Healthy participants received E2006 1 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 2.5 mg n=6 Participants Healthy participants received E2006 2.5 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 5 mg n=6 Participants Healthy participants received E2006 5 mg (2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 10 mg n=6 Participants Healthy participants received E2006 10 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 25 mg n=6 Participants Healthy participants received E2006 25 mg (2 capsules of 10 mg each and 2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 50 mg n=6 Participants Healthy participants received E2006 50 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 100 mg n=6 Participants Healthy participants received E2006 100 mg (2 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 200 mg Healthy participants received E2006 200 mg (4 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 200 mg Healthy participants received E2006 200 mg (4 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.
Part A: Apparent Total Clearance of E2006 From Plasma (CL/F)	44.8 liter per hour (L/h) Geometric Coefficient of Variation 39.0	28.2 liter per hour (L/h) Geometric Coefficient of Variation 54.2	33.9 liter per hour (L/h) Geometric Coefficient of Variation 18.6	33.4 liter per hour (L/h) Geometric Coefficient of Variation 31.8	17.0 liter per hour (L/h) Geometric Coefficient of Variation 33.4	24.8 liter per hour (L/h) Geometric Coefficient of Variation 40.3	22.1 liter per hour (L/h) Geometric Coefficient of Variation 36.9	20.2 liter per hour (L/h) Geometric Coefficient of Variation 39.4	—	—

SECONDARY outcome

Timeframe: Day 1: Pre-dose, up to 240 hours post-dose

Population: PK analysis set included all participants who had sufficient PK data to derive at least one PK parameter. PK parameters for Part B were not analyzed due to change in planned analysis.

Outcome measures

Outcome measures
Measure	Part A: E2006 Matched Placebo n=6 Participants Healthy participants received E2006-matched placebo, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 1.0 mg n=6 Participants Healthy participants received E2006 1 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 2.5 mg n=6 Participants Healthy participants received E2006 2.5 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 5 mg n=6 Participants Healthy participants received E2006 5 mg (2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 10 mg n=6 Participants Healthy participants received E2006 10 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 25 mg n=6 Participants Healthy participants received E2006 25 mg (2 capsules of 10 mg each and 2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 50 mg n=6 Participants Healthy participants received E2006 50 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 100 mg n=6 Participants Healthy participants received E2006 100 mg (2 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 200 mg Healthy participants received E2006 200 mg (4 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 200 mg Healthy participants received E2006 200 mg (4 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.
Part A: Apparent Volume of Distribution of E2006 in Plasma (Vz/F)	1170 liter (L) Geometric Coefficient of Variation 40.7	1200 liter (L) Geometric Coefficient of Variation 34.4	1610 liter (L) Geometric Coefficient of Variation 25.3	2670 liter (L) Geometric Coefficient of Variation 26.6	1580 liter (L) Geometric Coefficient of Variation 24.5	1810 liter (L) Geometric Coefficient of Variation 28.7	1930 liter (L) Geometric Coefficient of Variation 28.1	1680 liter (L) Geometric Coefficient of Variation 35.4	—	—

SECONDARY outcome

Timeframe: Day 1: Pre-dose, up to 120 hours post-dose

Population: PK analysis set included all participants who had sufficient PK data to derive at least one PK parameter. PK parameters for Part B were not analyzed due to change in planned analysis.

Outcome measures

Outcome measures
Measure	Part A: E2006 Matched Placebo n=6 Participants Healthy participants received E2006-matched placebo, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 1.0 mg n=6 Participants Healthy participants received E2006 1 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 2.5 mg n=6 Participants Healthy participants received E2006 2.5 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 5 mg n=6 Participants Healthy participants received E2006 5 mg (2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 10 mg n=6 Participants Healthy participants received E2006 10 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 25 mg n=6 Participants Healthy participants received E2006 25 mg (2 capsules of 10 mg each and 2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 50 mg n=6 Participants Healthy participants received E2006 50 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 100 mg n=6 Participants Healthy participants received E2006 100 mg (2 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 200 mg Healthy participants received E2006 200 mg (4 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 200 mg Healthy participants received E2006 200 mg (4 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.
Part A: Cumulative Amount of Unchanged Drug E2006 Excreted Into the Urine (Ae)	0.000108 milligram (mg) Geometric Coefficient of Variation 28.6	0.0000777 milligram (mg) Geometric Coefficient of Variation 126	0.000667 milligram (mg) Geometric Coefficient of Variation 153	0.00141 milligram (mg) Geometric Coefficient of Variation 47.4	0.00788 milligram (mg) Geometric Coefficient of Variation 72.1	0.0113 milligram (mg) Geometric Coefficient of Variation 23.1	0.0307 milligram (mg) Geometric Coefficient of Variation 65.5	0.0402 milligram (mg) Geometric Coefficient of Variation 56.8	—	—

SECONDARY outcome

Timeframe: Day 1: Pre-dose, up to 120 hours post-dose

Population: PK analysis set included all participants who had sufficient PK data to derive at least one PK parameter. PK parameters for Part B were not analyzed due to change in planned analysis.

Outcome measures

Outcome measures
Measure	Part A: E2006 Matched Placebo n=6 Participants Healthy participants received E2006-matched placebo, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 1.0 mg n=6 Participants Healthy participants received E2006 1 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 2.5 mg n=6 Participants Healthy participants received E2006 2.5 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 5 mg n=6 Participants Healthy participants received E2006 5 mg (2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 10 mg n=6 Participants Healthy participants received E2006 10 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 25 mg n=6 Participants Healthy participants received E2006 25 mg (2 capsules of 10 mg each and 2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 50 mg n=6 Participants Healthy participants received E2006 50 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 100 mg n=6 Participants Healthy participants received E2006 100 mg (2 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 200 mg Healthy participants received E2006 200 mg (4 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 200 mg Healthy participants received E2006 200 mg (4 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.
Part A: Renal Clearance (CLR) of Drug E2006	0.0877 milliliter per minute (mL/min) Geometric Coefficient of Variation 29.8	0.0157 milliliter per minute (mL/min) Geometric Coefficient of Variation 70.7	0.0881 milliliter per minute (mL/min) Geometric Coefficient of Variation 129	0.0938 milliliter per minute (mL/min) Geometric Coefficient of Variation 68.7	0.111 milliliter per minute (mL/min) Geometric Coefficient of Variation 66.2	0.107 milliliter per minute (mL/min) Geometric Coefficient of Variation 34.5	0.140 milliliter per minute (mL/min) Geometric Coefficient of Variation 44.6	0.0844 milliliter per minute (mL/min) Geometric Coefficient of Variation 41.7	—	—

SECONDARY outcome

Timeframe: Day 1 (Pre-dose), up to Day 6

Population: PD analysis set included all participants who had sufficient PD data to derive at least one PD parameter. Here "number analyzed" signifies participants who were evaluable for this outcome measure at given time points.

DSST is a cognitive test designed to assess psychomotor speed of performance requiring visual perception, spatial decision-making, and motor skills. It consists of 133 digits and requires the participant to substitute each digit with a simple symbol in a 90-second period. Each correct symbol is counted, and the total score ranges from 0 (less than cognitive functioning) to 133 (greater than cognitive functioning) as a description of DSST. An increase in score represents an improvement in an integrated measure of cognitive function. In this outcome measure, data for participants who received placebo matched to "1 mg, 2.5 mg, 5 mg E2006" and matched to "10 mg, 25 mg, 50 mg, 100 mg, and 200 mg E2006", has been presented separately.

Outcome measures

Outcome measures
Measure	Part A: E2006 Matched Placebo n=6 Participants Healthy participants received E2006-matched placebo, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 1.0 mg n=10 Participants Healthy participants received E2006 1 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 2.5 mg n=6 Participants Healthy participants received E2006 2.5 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 5 mg n=6 Participants Healthy participants received E2006 5 mg (2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 10 mg n=6 Participants Healthy participants received E2006 10 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 25 mg n=6 Participants Healthy participants received E2006 25 mg (2 capsules of 10 mg each and 2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 50 mg n=6 Participants Healthy participants received E2006 50 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 100 mg n=6 Participants Healthy participants received E2006 100 mg (2 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 200 mg n=6 Participants Healthy participants received E2006 200 mg (4 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 200 mg n=6 Participants Healthy participants received E2006 200 mg (4 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.
Part A: Maximum Change From Day 1 (Pre-dose) in Digit Symbol Substitution Test (DSST) Score at Day 6 Day 1 (Pre-dose)	53.7 score on a scale Standard Deviation 13.84	59.1 score on a scale Standard Deviation 15.27	52.3 score on a scale Standard Deviation 10.33	63.7 score on a scale Standard Deviation 8.57	61.2 score on a scale Standard Deviation 13.53	60.5 score on a scale Standard Deviation 9.97	59.2 score on a scale Standard Deviation 8.06	59.8 score on a scale Standard Deviation 8.80	56.5 score on a scale Standard Deviation 8.57	62.8 score on a scale Standard Deviation 18.93
Part A: Maximum Change From Day 1 (Pre-dose) in Digit Symbol Substitution Test (DSST) Score at Day 6 Maximum Change From Day 1 (Pre-dose) at Day 6	14.3 score on a scale Standard Deviation 14.01	7.8 score on a scale Standard Deviation 18.23	16.0 score on a scale Standard Deviation 11.42	9.0 score on a scale Standard Deviation 18.57	8.8 score on a scale Standard Deviation 18.81	-9.0 score on a scale Standard Deviation 34.71	5.8 score on a scale Standard Deviation 30.01	2.6 score on a scale Standard Deviation 27.57	-13.0 score on a scale Standard Deviation 18.97	-16.3 score on a scale Standard Deviation 34.62

SECONDARY outcome

Timeframe: Day 1 (Pre-dose), Day 6

Population: PD analysis set included all participants who had sufficient PD data to derive at least one PD parameter. Here "number analyzed" signifies participants who were evaluable for this outcome measure at given time points.

PVT, a computer-based test, is a chronometric measure of an individual's reaction to specified small changes in a labile environment. Participants were instructed to respond to a digital signal on a computer terminal by pressing a key. Errors of omission and commission are recorded. When a participant did not respond to the PVT signal within 500 msec, it was termed a lapse. The higher the number of lapses the greater the impairment. In this outcome measure, data for participants who received placebo matched to "1 mg, 2.5 mg, 5 mg E2006" and matched to "10 mg, 25 mg, 50 mg, 100 mg, and 200 mg E2006", has been presented separately.

Outcome measures

Outcome measures
Measure	Part A: E2006 Matched Placebo n=6 Participants Healthy participants received E2006-matched placebo, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 1.0 mg n=10 Participants Healthy participants received E2006 1 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 2.5 mg n=6 Participants Healthy participants received E2006 2.5 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 5 mg n=6 Participants Healthy participants received E2006 5 mg (2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 10 mg n=6 Participants Healthy participants received E2006 10 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 25 mg n=6 Participants Healthy participants received E2006 25 mg (2 capsules of 10 mg each and 2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 50 mg n=6 Participants Healthy participants received E2006 50 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 100 mg n=6 Participants Healthy participants received E2006 100 mg (2 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 200 mg n=6 Participants Healthy participants received E2006 200 mg (4 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 200 mg n=6 Participants Healthy participants received E2006 200 mg (4 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.
Part A: Maximum Change From Day 1 (Pre-dose) in Number of Lapses of > 500 Msec Assessed by Psychomotor Vigilance Test (PVT) at Day 6 Maximum Change From Day 1 (Pre-dose) at Day 6	6.0 lapses Standard Deviation 10.70	4.7 lapses Standard Deviation 3.37	3.4 lapses Standard Deviation 2.07	1.4 lapses Standard Deviation 4.45	2.5 lapses Standard Deviation 9.33	22.6 lapses Standard Deviation 10.45	19.7 lapses Standard Deviation 19.50	26.6 lapses Standard Deviation 12.42	29.2 lapses Standard Deviation 14.13	32.0 lapses Standard Deviation 16.63
Part A: Maximum Change From Day 1 (Pre-dose) in Number of Lapses of > 500 Msec Assessed by Psychomotor Vigilance Test (PVT) at Day 6 Day 1 (Pre-dose)	1.0 lapses Standard Deviation 0.89	1.8 lapses Standard Deviation 2.39	1.3 lapses Standard Deviation 2.42	2.5 lapses Standard Deviation 2.43	1.3 lapses Standard Deviation 1.97	1.5 lapses Standard Deviation 1.38	0.3 lapses Standard Deviation 0.52	2.5 lapses Standard Deviation 2.07	2.0 lapses Standard Deviation 1.90	6.5 lapses Standard Deviation 4.18

SECONDARY outcome

Timeframe: Day 1 (Pre-dose), Day 6

Population: PD analysis set included all participants who had sufficient PD data to derive at least one PD parameter. Here "number analyzed" signifies participants who were evaluable for this outcome measure at given time points.

KSS is a 9-point scale, on which the participant has to mark his or her sleepiness during the previous 10 minutes. The scale ranges from 1, which indicates "extremely alert", to 9, which indicates "extremely sleepy, can't stay awake". Higher numbers indicating sleepier and lower numbers more alert. In this outcome measure, data for participants who received placebo matched to "1 mg, 2.5 mg, 5 mg E2006" and matched to "10 mg, 25 mg, 50 mg, 100 mg, and 200 mg E2006", has been presented separately.

Outcome measures

Outcome measures
Measure	Part A: E2006 Matched Placebo n=6 Participants Healthy participants received E2006-matched placebo, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 1.0 mg n=10 Participants Healthy participants received E2006 1 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 2.5 mg n=6 Participants Healthy participants received E2006 2.5 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 5 mg n=6 Participants Healthy participants received E2006 5 mg (2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 10 mg n=6 Participants Healthy participants received E2006 10 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 25 mg n=6 Participants Healthy participants received E2006 25 mg (2 capsules of 10 mg each and 2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 50 mg n=6 Participants Healthy participants received E2006 50 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 100 mg n=6 Participants Healthy participants received E2006 100 mg (2 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 200 mg n=6 Participants Healthy participants received E2006 200 mg (4 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 200 mg n=6 Participants Healthy participants received E2006 200 mg (4 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.
Part A: Maximum Change From Day 1 (Pre-dose) in Karolinska Sleepiness Scale (KSS) Score at Day 6 Day 1 (Pre-dose)	5.2 score on a scale Standard Deviation 1.83	2.8 score on a scale Standard Deviation 1.48	3.2 score on a scale Standard Deviation 0.98	3.8 score on a scale Standard Deviation 2.04	3.5 score on a scale Standard Deviation 2.88	3.0 score on a scale Standard Deviation 1.10	2.0 score on a scale Standard Deviation 1.10	2.3 score on a scale Standard Deviation 2.07	2.2 score on a scale Standard Deviation 0.98	2.5 score on a scale Standard Deviation 1.52
Part A: Maximum Change From Day 1 (Pre-dose) in Karolinska Sleepiness Scale (KSS) Score at Day 6 Maximum Change From Day 1 (Pre-dose) at Day 6	-0.8 score on a scale Standard Deviation 4.02	0.5 score on a scale Standard Deviation 2.95	0.0 score on a scale Standard Deviation 2.55	-0.2 score on a scale Standard Deviation 3.13	0.8 score on a scale Standard Deviation 4.60	5.3 score on a scale Standard Deviation 1.21	4.8 score on a scale Standard Deviation 2.99	5.4 score on a scale Standard Deviation 3.44	6.0 score on a scale Standard Deviation 1.26	6.3 score on a scale Standard Deviation 1.86

SECONDARY outcome

Timeframe: Day 1, Day 6

Population: PD analysis set included all participants who had sufficient PD data to derive at least one PD parameter. Here "number analyzed" signifies participants who were evaluable for the outcome measure at given time points.

Participants were asked to answer the following question using Waketime Questionnaire: How long did you sleep last night, number of awakening after falling asleep, time to fall asleep last night, time spent awake after falling asleep, rate quality of your sleep (using Likert scale, ranged from 0 = very sound or restful, to 4 = very restless where lower score indicates better outcome). The primary purpose of the Waketime Questionnaire was to confirm a lack of sleep disturbance. In this outcome measure, data for question "How long did you sleep last night" has been reported.

Outcome measures

Outcome measures
Measure	Part A: E2006 Matched Placebo n=16 Participants Healthy participants received E2006-matched placebo, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 1.0 mg n=6 Participants Healthy participants received E2006 1 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 2.5 mg n=6 Participants Healthy participants received E2006 2.5 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 5 mg n=6 Participants Healthy participants received E2006 5 mg (2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 10 mg n=6 Participants Healthy participants received E2006 10 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 25 mg n=6 Participants Healthy participants received E2006 25 mg (2 capsules of 10 mg each and 2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 50 mg n=6 Participants Healthy participants received E2006 50 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 100 mg n=6 Participants Healthy participants received E2006 100 mg (2 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 200 mg n=6 Participants Healthy participants received E2006 200 mg (4 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 200 mg Healthy participants received E2006 200 mg (4 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.
Part A: Change From Day 1 in Waketime Questionnaire Parameters: How Long Did You Sleep Last Night at Day 6 Day 1	457.7 minutes Standard Deviation 24.81	475.0 minutes Standard Deviation 12.25	443.3 minutes Standard Deviation 42.39	436.7 minutes Standard Deviation 36.29	473.3 minutes Standard Deviation 7.53	469.2 minutes Standard Deviation 26.54	438.3 minutes Standard Deviation 21.37	455.0 minutes Standard Deviation 48.06	434.2 minutes Standard Deviation 45.21	—
Part A: Change From Day 1 in Waketime Questionnaire Parameters: How Long Did You Sleep Last Night at Day 6 Change From Day 1 at Day 6	3.0 minutes Standard Deviation 29.58	—	—	—	-85.8 minutes Standard Deviation 82.12	10.8 minutes Standard Deviation 26.54	22.5 minutes Standard Deviation 32.52	-4.2 minutes Standard Deviation 21.54	-11.0 minutes Standard Deviation 79.23	—

SECONDARY outcome

Timeframe: Day 1, Day 6

Population: PD analysis set included all participants who had sufficient PD data to derive at least one PD parameter. Here "number analyzed" signifies participants who were evaluable for the outcome measure at given time points.

Participants were asked to answer the following question using Waketime Questionnaire: How long did you sleep last night, number of awakening after falling asleep, time to fall asleep last night, time spent awake after falling asleep, rate quality of your sleep (using Likert scale, ranged from 0 = very sound or restful, to 4 = very restless where lower score indicates better outcome). The primary purpose of the Waketime Questionnaire was to confirm a lack of sleep disturbance. In this outcome measure, data for question "Time to fall asleep last night" has been reported.

Outcome measures

Outcome measures
Measure	Part A: E2006 Matched Placebo n=16 Participants Healthy participants received E2006-matched placebo, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 1.0 mg n=6 Participants Healthy participants received E2006 1 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 2.5 mg n=6 Participants Healthy participants received E2006 2.5 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 5 mg n=6 Participants Healthy participants received E2006 5 mg (2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 10 mg n=6 Participants Healthy participants received E2006 10 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 25 mg n=6 Participants Healthy participants received E2006 25 mg (2 capsules of 10 mg each and 2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 50 mg n=6 Participants Healthy participants received E2006 50 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 100 mg n=6 Participants Healthy participants received E2006 100 mg (2 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 200 mg n=6 Participants Healthy participants received E2006 200 mg (4 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 200 mg Healthy participants received E2006 200 mg (4 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.
Part A: Change From Day 1 in Waketime Questionnaire Parameters: Time to Fall Asleep Last Night at Day 6 Day 1	13.2 minutes Standard Deviation 6.99	15.7 minutes Standard Deviation 9.73	17.2 minutes Standard Deviation 9.91	14.5 minutes Standard Deviation 10.17	15.0 minutes Standard Deviation 8.94	16.7 minutes Standard Deviation 7.53	15.8 minutes Standard Deviation 3.76	10.0 minutes Standard Deviation 5.48	15.0 minutes Standard Deviation 7.07	—
Part A: Change From Day 1 in Waketime Questionnaire Parameters: Time to Fall Asleep Last Night at Day 6 Change From Day 1 at Day 6	2.1 minutes Standard Deviation 10.46	—	—	—	20.0 minutes Standard Deviation 39.37	-4.7 minutes Standard Deviation 6.68	-3.8 minutes Standard Deviation 5.49	4.2 minutes Standard Deviation 3.76	7.0 minutes Standard Deviation 27.93	—

SECONDARY outcome

Timeframe: Day 1, Day 6

Population: PD analysis set included all participants who had sufficient PD data to derive at least one PD parameter. Here "number analyzed" signifies participants who were evaluable for the outcome measure at given time points.

Participants were asked to answer the following question using Waketime Questionnaire: How long did you sleep last night, number of awakening after falling asleep, time to fall asleep last night, time spent awake after falling asleep, rate quality of your sleep (using Likert scale, ranged from 0 = very sound or restful, to 4 = very restless where lower score indicates better outcome). The primary purpose of the Waketime Questionnaire was to confirm a lack of sleep disturbance. In this outcome measure, data for question "Number of awakening after falling asleep" has been reported.

Outcome measures

Outcome measures
Measure	Part A: E2006 Matched Placebo n=16 Participants Healthy participants received E2006-matched placebo, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 1.0 mg n=6 Participants Healthy participants received E2006 1 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 2.5 mg n=6 Participants Healthy participants received E2006 2.5 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 5 mg n=6 Participants Healthy participants received E2006 5 mg (2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 10 mg n=6 Participants Healthy participants received E2006 10 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 25 mg n=6 Participants Healthy participants received E2006 25 mg (2 capsules of 10 mg each and 2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 50 mg n=6 Participants Healthy participants received E2006 50 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 100 mg n=6 Participants Healthy participants received E2006 100 mg (2 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 200 mg n=6 Participants Healthy participants received E2006 200 mg (4 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 200 mg Healthy participants received E2006 200 mg (4 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.
Part A: Change From Day 1 in Waketime Questionnaire Parameters: Number of Awakening After Falling Asleep at Day 6 Day 1	1.1 number of awakenings Standard Deviation 0.77	1.8 number of awakenings Standard Deviation 0.75	1.3 number of awakenings Standard Deviation 1.03	0.8 number of awakenings Standard Deviation 0.75	0.5 number of awakenings Standard Deviation 0.84	1.2 number of awakenings Standard Deviation 0.98	0.8 number of awakenings Standard Deviation 0.98	1.8 number of awakenings Standard Deviation 0.41	1.8 number of awakenings Standard Deviation 1.72	—
Part A: Change From Day 1 in Waketime Questionnaire Parameters: Number of Awakening After Falling Asleep at Day 6 Change From Day 1 at Day 6	-0.6 number of awakenings Standard Deviation 1.24	—	—	—	1.7 number of awakenings Standard Deviation 1.97	0.3 number of awakenings Standard Deviation 1.51	0.2 number of awakenings Standard Deviation 0.41	-0.7 number of awakenings Standard Deviation 1.03	-1.0 number of awakenings Standard Deviation 1.79	—

SECONDARY outcome

Timeframe: Day 1, Day 6

Population: PD analysis set included all participants who had sufficient PD data to derive at least one PD parameter. Here "number analyzed" signifies participants who were evaluable for the outcome measure at given time points.

Participants were asked to answer the following question using Waketime Questionnaire: How long did you sleep last night, number of awakening after falling asleep, time to fall asleep last night, time spent awake after falling asleep, rate quality of your sleep (using Likert scale, ranged from 0 = very sound or restful, to 4 = very restless where lower score indicates better outcome). The primary purpose of the Waketime Questionnaire was to confirm a lack of sleep disturbance. In this outcome measure, data for question "Time spent awake after falling asleep" has been reported.

Outcome measures

Outcome measures
Measure	Part A: E2006 Matched Placebo n=16 Participants Healthy participants received E2006-matched placebo, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 1.0 mg n=6 Participants Healthy participants received E2006 1 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 2.5 mg n=6 Participants Healthy participants received E2006 2.5 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 5 mg n=6 Participants Healthy participants received E2006 5 mg (2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 10 mg n=6 Participants Healthy participants received E2006 10 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 25 mg n=6 Participants Healthy participants received E2006 25 mg (2 capsules of 10 mg each and 2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 50 mg n=6 Participants Healthy participants received E2006 50 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 100 mg n=6 Participants Healthy participants received E2006 100 mg (2 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 200 mg n=6 Participants Healthy participants received E2006 200 mg (4 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 200 mg Healthy participants received E2006 200 mg (4 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.
Part A: Change From Day 1 in Waketime Questionnaire Parameters: Time Spent Awake After Falling Asleep at Day 6 Day 1	4.6 minutes Standard Deviation 4.86	6.2 minutes Standard Deviation 3.76	16.8 minutes Standard Deviation 22.14	5.3 minutes Standard Deviation 7.53	1.7 minutes Standard Deviation 2.58	5.0 minutes Standard Deviation 4.47	5.0 minutes Standard Deviation 6.32	11.2 minutes Standard Deviation 5.60	6.7 minutes Standard Deviation 4.08	—
Part A: Change From Day 1 in Waketime Questionnaire Parameters: Time Spent Awake After Falling Asleep at Day 6 Change From Day 1 at Day 6	-1.9 minutes Standard Deviation 8.18	—	—	—	53.3 minutes Standard Deviation 53.82	5.0 minutes Standard Deviation 8.37	5.0 minutes Standard Deviation 4.65	-3.0 minutes Standard Deviation 7.75	-2.5 minutes Standard Deviation 4.37	—

SECONDARY outcome

Timeframe: Day 1, Day 6

Population: PD analysis set included all participants who had sufficient PD data to derive at least one PD parameter. Here "number analyzed" signifies participants who were evaluable for the outcome measure at given time points.

Participants were asked to answer the following question using Waketime Questionnaire: How long did you sleep last night, number of awakening after falling asleep, time to fall asleep last night, time spent awake after falling asleep, rate quality of your sleep (using Likert scale, ranged from 0 = very sound or restful, to 4 = very restless where lower score indicates better outcome). The primary purpose of the Waketime Questionnaire was to confirm a lack of sleep disturbance. In this outcome measure, data for question "Rate quality of your sleep" has been reported.

Outcome measures

Outcome measures
Measure	Part A: E2006 Matched Placebo n=16 Participants Healthy participants received E2006-matched placebo, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 1.0 mg n=6 Participants Healthy participants received E2006 1 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 2.5 mg n=6 Participants Healthy participants received E2006 2.5 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 5 mg n=6 Participants Healthy participants received E2006 5 mg (2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 10 mg n=6 Participants Healthy participants received E2006 10 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 25 mg n=6 Participants Healthy participants received E2006 25 mg (2 capsules of 10 mg each and 2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 50 mg n=6 Participants Healthy participants received E2006 50 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 100 mg n=6 Participants Healthy participants received E2006 100 mg (2 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 200 mg n=6 Participants Healthy participants received E2006 200 mg (4 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 200 mg Healthy participants received E2006 200 mg (4 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.
Part A: Change From Day 1 in Waketime Questionnaire Parameters: Rate Quality of Your Sleep at Day 6 Day 1	1.1 score on a scale Standard Deviation 0.77	0.3 score on a scale Standard Deviation 0.52	1.5 score on a scale Standard Deviation 1.22	0.7 score on a scale Standard Deviation 0.82	1.0 score on a scale Standard Deviation 0.00	0.5 score on a scale Standard Deviation 0.84	1.0 score on a scale Standard Deviation 0.89	0.8 score on a scale Standard Deviation 0.98	1.5 score on a scale Standard Deviation 0.84	—
Part A: Change From Day 1 in Waketime Questionnaire Parameters: Rate Quality of Your Sleep at Day 6 Change From Day 1 at Day 6	0.2 score on a scale Standard Deviation 0.67	—	—	—	1.3 score on a scale Standard Deviation 1.03	0.0 score on a scale Standard Deviation 0.00	0.0 score on a scale Standard Deviation 0.00	0.2 score on a scale Standard Deviation 0.75	-0.2 score on a scale Standard Deviation 1.17	—

SECONDARY outcome

Timeframe: Baseline up to Day 11

Population: Safety analysis set included all participants who received study drug and had at least one postdose safety assessment.

Outcome measures

Outcome measures
Measure	Part A: E2006 Matched Placebo n=12 Participants Healthy participants received E2006-matched placebo, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 1.0 mg n=11 Participants Healthy participants received E2006 1 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 2.5 mg n=13 Participants Healthy participants received E2006 2.5 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 5 mg n=10 Participants Healthy participants received E2006 5 mg (2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 10 mg n=12 Participants Healthy participants received E2006 10 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 25 mg Healthy participants received E2006 25 mg (2 capsules of 10 mg each and 2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 50 mg Healthy participants received E2006 50 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 100 mg Healthy participants received E2006 100 mg (2 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 200 mg Healthy participants received E2006 200 mg (4 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 200 mg Healthy participants received E2006 200 mg (4 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.
Part B: Number of Participants With Treatment Emergent Adverse Events (AEs) and Treatment Emergent Serious Adverse Events (SAEs) AEs	1 Participants	6 Participants	2 Participants	6 Participants	6 Participants	—	—	—	—	—
Part B: Number of Participants With Treatment Emergent Adverse Events (AEs) and Treatment Emergent Serious Adverse Events (SAEs) SAEs	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline up to Day 6

Population: Safety analysis set included all participants who received study drug and had at least one postdose safety assessment.

Outcome measures

Outcome measures
Measure	Part A: E2006 Matched Placebo n=12 Participants Healthy participants received E2006-matched placebo, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 1.0 mg n=11 Participants Healthy participants received E2006 1 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 2.5 mg n=13 Participants Healthy participants received E2006 2.5 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 5 mg n=10 Participants Healthy participants received E2006 5 mg (2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 10 mg n=12 Participants Healthy participants received E2006 10 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 25 mg Healthy participants received E2006 25 mg (2 capsules of 10 mg each and 2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 50 mg Healthy participants received E2006 50 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 100 mg Healthy participants received E2006 100 mg (2 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 200 mg Healthy participants received E2006 200 mg (4 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 200 mg Healthy participants received E2006 200 mg (4 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.
Part B: Number of Participants With Markedly Abnormal Laboratory Parameter Values	3 Participants	6 Participants	4 Participants	3 Participants	7 Participants	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline up to Day 11

Population: Safety analysis set included all participants who received study drug and had at least one postdose safety assessment.

Outcome measures

Outcome measures
Measure	Part A: E2006 Matched Placebo n=12 Participants Healthy participants received E2006-matched placebo, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 1.0 mg n=11 Participants Healthy participants received E2006 1 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 2.5 mg n=13 Participants Healthy participants received E2006 2.5 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 5 mg n=10 Participants Healthy participants received E2006 5 mg (2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 10 mg n=12 Participants Healthy participants received E2006 10 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 25 mg Healthy participants received E2006 25 mg (2 capsules of 10 mg each and 2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 50 mg Healthy participants received E2006 50 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 100 mg Healthy participants received E2006 100 mg (2 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 200 mg Healthy participants received E2006 200 mg (4 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 200 mg Healthy participants received E2006 200 mg (4 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.
Part B: Number of Participants With Significant Change From Baseline in Vital Sign Values	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline up to Day 11

Population: Safety analysis set included all participants who received study drug and had at least one postdose safety assessment.

Outcome measures

Outcome measures
Measure	Part A: E2006 Matched Placebo n=12 Participants Healthy participants received E2006-matched placebo, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 1.0 mg n=11 Participants Healthy participants received E2006 1 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 2.5 mg n=13 Participants Healthy participants received E2006 2.5 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 5 mg n=10 Participants Healthy participants received E2006 5 mg (2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 10 mg n=12 Participants Healthy participants received E2006 10 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 25 mg Healthy participants received E2006 25 mg (2 capsules of 10 mg each and 2 capsules of 2.5 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 50 mg Healthy participants received E2006 50 mg, capsule, orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 100 mg Healthy participants received E2006 100 mg (2 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 200 mg Healthy participants received E2006 200 mg (4 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.	Part A: E2006 200 mg Healthy participants received E2006 200 mg (4 capsules of 50 mg each), orally in the morning, one hour after lights-on, on Day 1.
Part B: Number of Participants With Clinically Significant Change From Baseline in ECG Parameter Values	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, Day 11

Population: Safety analysis set included all participants who received study drug and had at least one postdose safety assessment.

The C-SSRS (mapped to Columbia Classification Algorithm of Suicide Assessment \[C-CASA\]) is an interview-based rating scale to systematically assess any suicidality, any suicidal Behavior, any suicidal ideation. Any suicidality: emergence of any suicidal ideation or suicidal behavior. Any suicidal behavior: when response is "yes" for any these questions- actual attempt to suicide, engaged in non-suicidal self-injurious, behavior, interrupted attempt, aborted attempt, preparatory acts. Any suicidal ideation: when response is "yes" for any of these questions-wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent to suicide. Number of participants with any suicidality has been reported for this outcome measure.