| Primary | Part A: Number of Participants With Treatment Emergent Adverse Events (AEs) and Treatment Emergent Serious Adverse Events (SAEs) | | Safety analysis set included all participants who received study drug and had at least one postdose safety assessment. | Posted | | Count of Participants | | Participants | | Baseline up to Day 11 | | | | ID | Title | Description |
|---|
| OG000 | Part A: E2006 Matched Placebo | Healthy participants received E2006-matched placebo, capsule, orally in the morning, one hour after lights-on, on Day 1. | | OG001 | Part A: E2006 1.0 mg | Healthy participants received E2006 1 mg, capsule, orally in the morning, one hour after lights-on, on Day 1. | | OG002 | 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. | | OG003 | 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. | | OG004 | Part A: E2006 10 mg | Healthy participants received E2006 10 mg, capsule, orally in the morning, one hour after lights-on, on Day 1. | | OG005 | 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. | | OG006 | Part A: E2006 50 mg | Healthy participants received E2006 50 mg, capsule, orally in the morning, one hour after lights-on, on Day 1. | | OG007 | 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. | | OG008 | 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. |
| | | Title | Denominators | Categories |
|---|
| AEs | | |
| |
| Primary | Part A: Number of Participants With Markedly Abnormal Laboratory Parameter Values | | Safety analysis set included all participants who received study drug and had at least one postdose safety assessment. | Posted | | Count of Participants | | Participants | | Baseline up to Day 6 | | | | ID | Title | Description |
|---|
| OG000 | Part A: E2006 Matched Placebo | Healthy participants received E2006-matched placebo, capsule, orally in the morning, one hour after lights-on, on Day 1. | | OG001 | Part A: E2006 1.0 mg | Healthy participants received E2006 1 mg, capsule, orally in the morning, one hour after lights-on, on Day 1. | | OG002 | 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. | | OG003 | 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. | | OG004 |
|
| Primary | Part A: Number of Participants With Significant Change From Baseline in Vital Sign Values | | Safety analysis set included all participants who received study drug and had at least one postdose safety assessment. | Posted | | Count of Participants | | Participants | | Baseline up to Day 11 | | | | ID | Title | Description |
|---|
| OG000 | Part A: E2006 Matched Placebo | Healthy participants received E2006-matched placebo, capsule, orally in the morning, one hour after lights-on, on Day 1. | | OG001 | Part A: E2006 1.0 mg | Healthy participants received E2006 1 mg, capsule, orally in the morning, one hour after lights-on, on Day 1. | | OG002 | 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. | | OG003 | 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. | | OG004 |
|
| Primary | Part A: Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Parameter Values | | Safety analysis set included all participants who received study drug and had at least one postdose safety assessment. | Posted | | Count of Participants | | Participants | | Baseline up to Day 11 | | | | ID | Title | Description |
|---|
| OG000 | Part A: E2006 Matched Placebo | Healthy participants received E2006-matched placebo, capsule, orally in the morning, one hour after lights-on, on Day 1. | | OG001 | Part A: E2006 1.0 mg | Healthy participants received E2006 1 mg, capsule, orally in the morning, one hour after lights-on, on Day 1. | | OG002 | 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. | | OG003 | 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. | |
|
| Primary | Part A: Number of Participants With Any Suicidality Assessed Using Columbia-Suicide Severity Rating Scale (C-SSRS) | 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. | Safety analysis set included all participants who received study drug and had at least one postdose safety assessment. | Posted | | Count of Participants | | Participants | | Baseline, Day 11 | | | | ID | Title | Description |
|---|
| OG000 | Part A: E2006 Matched Placebo | Healthy participants received E2006-matched placebo, capsule, orally in the morning, one hour after lights-on, on Day 1. | | OG001 | Part A: E2006 1.0 mg | Healthy participants received E2006 1 mg, capsule, orally in the morning, one hour after lights-on, on Day 1. |
|
| Primary | Part B: Change From Baseline in Latency to Persistent Sleep (LPS) Assessed Using Polysomnography (PSG) Measurement at Day 1 | 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. | Pharmacodynamic (PD) analysis set included all participants who had sufficient PD data to derive at least one PD parameter. | Posted | | Mean | Standard Deviation | minutes | | Baseline, Day 1 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
|
| Primary | Part B: Change From Baseline in Total Sleep Time (TST) Assessed Using PSG at Day 1 | 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. | PD analysis set included all participants who had sufficient PD data to derive at least one PD parameter. | Posted | | Mean | Standard Deviation | minutes | | Baseline, Day 1 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. | |
|
| Primary | Part B: Change From Baseline in Sleep Efficiency Assessed Using PSG at Day 1 | 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. | PD analysis set included all participants who had sufficient PD data to derive at least one PD parameter. | Posted | | Mean | Standard Deviation | percentage of time asleep | | Baseline, Day 1 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
|
| Primary | Part B: Change From Baseline in Wake After Sleep Onset (WASO) Assessed Using PSG at Day 1 | WASO was defined as the duration (in minutes) of wakefulness from onset of persistent sleep to lights-on. | PD analysis set included all participants who had sufficient PD data to derive at least one PD parameter. | Posted | | Mean | Standard Deviation | minutes | | Baseline, Day 1 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. | | OG003 |
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| Primary | Part B: Change From Baseline in Number of Awakenings After Persistent Sleep (NAW) Assessed Using PSG at Day 1 | 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. | PD analysis set included all participants who had sufficient PD data to derive at least one PD parameter. | Posted | | Mean | Standard Deviation | awakenings | | Baseline, Day 1 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
|
| Primary | Part B: Change From Baseline in Percentage of Each Sleep Stage Duration Assessed Using PSG at Day 1 | 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. | PD analysis set included all participants who had sufficient PD data to derive at least one PD parameter. | Posted | | Mean | Standard Deviation | percentage of sleep stage duration | | Baseline, Day 1 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
|
| Primary | Part B: Change From Baseline in Duration (in Minutes) of Each Sleep Stage Assessed Using PSG at Day 1 | 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. | PD analysis set included all participants who had sufficient PD data to derive at least one PD parameter. | Posted | | Mean | Standard Deviation | minutes | | Baseline, Day 1 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
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| Primary | Part B: Change From Baseline in Mean Total Number of Shift in Sleep Stages Assessed Using PSG at Day 1 | 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. | PD analysis set included all participants who had sufficient PD data to derive at least one PD parameter. | Posted | | Mean | Standard Deviation | stage shift | | Baseline, Day 1 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
|
| Primary | Part B: Change From Day 1 in Waketime Questionnaire Parameters: How Long Did You Sleep Last Night at Day 6 | 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. | PD analysis set included all participants who had sufficient PD data to derive at least one PD parameter. | Posted | | Mean | Standard Deviation | minutes | | Day 1, Day 6 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | |
|
| Primary | Part B: Change From Day 1 in Waketime Questionnaire Parameters: Time to Fall Asleep Last Night at Day 6 | 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. | PD analysis set included all participants who had sufficient PD data to derive at least one PD parameter. | Posted | | Mean | Standard Deviation | minutes | | Day 1, Day 6 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | |
|
| Primary | Part B: Change From Day 1 in Waketime Questionnaire Parameters: Number of Awakening After Falling Asleep at Day 6 | 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. | PD analysis set included all participants who had sufficient PD data to derive at least one PD parameter. | Posted | | Mean | Standard Deviation | number of awakenings | | Day 1, Day 6 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
|
| Primary | Part B: Change From Day 1 in Waketime Questionnaire Parameters: Time Spent Awake After Falling Asleep at Day 6 | 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. | PD analysis set included all participants who had sufficient PD data to derive at least one PD parameter. | Posted | | Mean | Standard Deviation | minutes | | Day 1, Day 6 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | |
|
| Primary | Part B: Change From Day 1 in Waketime Questionnaire Parameters: Rate Quality of Your Sleep at Day 6 | 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. | PD analysis set included all participants who had sufficient PD data to derive at least one PD parameter. | Posted | | Mean | Standard Deviation | score on a scale | | Day 1, Day 6 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | |
|
| Primary | Part B: Change From Day 1 (Pre-dose) in Digit Symbol Substitution Test (DSST) Score at Day 6 | 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. | PD analysis set included all participants who had sufficient PD data to derive at least one PD parameter. | Posted | | Mean | Standard Deviation | score on a scale | | Day 1 (Pre-dose), Day 6 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 |
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| Primary | 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 | 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. | 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. | Posted | | Mean | Standard Deviation | lapses | | Day 1 (Pre-dose), Day 6 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
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| Primary | Part B: Change From Day 1 (Pre-dose) in Score on Karolinska Sleepiness Scale (KSS) at Day 6 | 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. | PD analysis set included all participants who had sufficient PD data to derive at least one PD parameter. | Posted | | Mean | Standard Deviation | score on a scale | | Day 1 (Pre-dose), Day 6 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
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| Secondary | Part A: Maximum Plasma Concentration (Cmax) of E2006 | | 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. | Posted | | Geometric Mean | Geometric Coefficient of Variation | nanogram per milliliter (ng/mL) | | Day 1: Pre-dose, up to 240 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Part A: E2006 1.0 mg | Healthy participants received E2006 1 mg, capsule, orally in the morning, one hour after lights-on, on Day 1. | | OG001 | 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. | | OG002 | 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. | | OG003 | Part A: E2006 10 mg | Healthy participants received E2006 10 mg, capsule, orally in the morning, one hour after lights-on, on Day 1. |
|
| Secondary | Part A: Time to Reach Maximum Plasma Concentration (Tmax) of E2006 | | 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. | Posted | | Median | Full Range | hours | | Day 1: Pre-dose, up to 240 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Part A: E2006 1.0 mg | Healthy participants received E2006 1 mg, capsule, orally in the morning, one hour after lights-on, on Day 1. | | OG001 | 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. | | OG002 | 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. | | OG003 | Part A: E2006 10 mg | Healthy participants received E2006 10 mg, capsule, orally in the morning, one hour after lights-on, on Day 1. | |
|
| Secondary | Part A: Area Under the Plasma Concentration-time Curve From Time Zero to 24 Hours (AUC0-24) of E2006 | | 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. | Posted | | Geometric Mean | Geometric Coefficient of Variation | nanogram hour per milliliter (ng*h/mL) | | Day 1: Pre-dose, up to 240 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Part A: E2006 1.0 mg | Healthy participants received E2006 1 mg, capsule, orally in the morning, one hour after lights-on, on Day 1. | | OG001 | 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. | | OG002 | 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. | | OG003 | Part A: E2006 10 mg | Healthy participants received E2006 10 mg, capsule, orally in the morning, one hour after lights-on, on Day 1. |
|
| Secondary | Part A: Area Under the Plasma Concentration-time Curve From Time Zero to t Hours (AUC0-t) of E2006 | | 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. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | | Day 1: Pre-dose, up to 240 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Part A: E2006 1.0 mg | Healthy participants received E2006 1 mg, capsule, orally in the morning, one hour after lights-on, on Day 1. | | OG001 | 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. | | OG002 | 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. | | OG003 | Part A: E2006 10 mg | Healthy participants received E2006 10 mg, capsule, orally in the morning, one hour after lights-on, on Day 1. |
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| Secondary | Part A: Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of E2006 | | 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. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | | Day 1: Pre-dose, up to 240 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Part A: E2006 1.0 mg | Healthy participants received E2006 1 mg, capsule, orally in the morning, one hour after lights-on, on Day 1. | | OG001 | 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. | | OG002 | 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. | | OG003 | Part A: E2006 10 mg | |
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| Secondary | Part A: Terminal Half-life (t1/2) of E2006 in Plasma | | 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. | Posted | | Median | Full Range | hours | | Day 1: Pre-dose, up to 240 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Part A: E2006 1.0 mg | Healthy participants received E2006 1 mg, capsule, orally in the morning, one hour after lights-on, on Day 1. | | OG001 | 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. | | OG002 | 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. | | OG003 | Part A: E2006 10 mg | Healthy participants received E2006 10 mg, capsule, orally in the morning, one hour after lights-on, on Day 1. | |
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| Secondary | Part A: Apparent Total Clearance of E2006 From Plasma (CL/F) | | 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. | Posted | | Geometric Mean | Geometric Coefficient of Variation | liter per hour (L/h) | | Day 1: Pre-dose, up to 240 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Part A: E2006 1.0 mg | Healthy participants received E2006 1 mg, capsule, orally in the morning, one hour after lights-on, on Day 1. | | OG001 | 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. | | OG002 | 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. | | OG003 | Part A: E2006 10 mg | Healthy participants received E2006 10 mg, capsule, orally in the morning, one hour after lights-on, on Day 1. |
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| Secondary | Part A: Apparent Volume of Distribution of E2006 in Plasma (Vz/F) | | 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. | Posted | | Geometric Mean | Geometric Coefficient of Variation | liter (L) | | Day 1: Pre-dose, up to 240 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Part A: E2006 1.0 mg | Healthy participants received E2006 1 mg, capsule, orally in the morning, one hour after lights-on, on Day 1. | | OG001 | 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. | | OG002 | 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. | | OG003 | Part A: E2006 10 mg | Healthy participants received E2006 10 mg, capsule, orally in the morning, one hour after lights-on, on Day 1. |
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| Secondary | Part A: Cumulative Amount of Unchanged Drug E2006 Excreted Into the Urine (Ae) | | 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. | Posted | | Geometric Mean | Geometric Coefficient of Variation | milligram (mg) | | Day 1: Pre-dose, up to 120 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Part A: E2006 1.0 mg | Healthy participants received E2006 1 mg, capsule, orally in the morning, one hour after lights-on, on Day 1. | | OG001 | 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. | | OG002 | 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. | | OG003 | Part A: E2006 10 mg | Healthy participants received E2006 10 mg, capsule, orally in the morning, one hour after lights-on, on Day 1. |
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| Secondary | Part A: Renal Clearance (CLR) of Drug E2006 | | 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. | Posted | | Geometric Mean | Geometric Coefficient of Variation | milliliter per minute (mL/min) | | Day 1: Pre-dose, up to 120 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | Part A: E2006 1.0 mg | Healthy participants received E2006 1 mg, capsule, orally in the morning, one hour after lights-on, on Day 1. | | OG001 | 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. | | OG002 | 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. | | OG003 | Part A: E2006 10 mg | Healthy participants received E2006 10 mg, capsule, orally in the morning, one hour after lights-on, on Day 1. |
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| Secondary | Part A: Maximum Change From Day 1 (Pre-dose) in Digit Symbol Substitution Test (DSST) Score at Day 6 | 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. | 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. | Posted | | Mean | Standard Deviation | score on a scale | | Day 1 (Pre-dose), up to Day 6 | | | | ID | Title | Description |
|---|
| OG000 | Part A: Placebo: Matched to 1, 2.5, 5 mg E2006 | Healthy participants received E2006-matched placebo (matched to 1 mg, 2.5 mg and 5 mg E2006), capsule, orally in the morning, one hour after lights-on, on Day 1. | | OG001 | Part A: Placebo: Matched to 10, 25, 50, 100, 200 mg E2006 | Healthy participants received E2006-matched placebo (matched to 10 mg, 25 mg, 50 mg, 100 mg, and 200 mg E2006), capsule, orally in the morning, one hour after lights-on, on Day 1. |
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| Secondary | 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 | 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. | 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. | Posted | | Mean | Standard Deviation | lapses | | Day 1 (Pre-dose), Day 6 | | | | ID | Title | Description |
|---|
| OG000 | Part A: Placebo: Matched to 1, 2.5, 5 mg E2006 | Healthy participants received E2006-matched placebo (matched to 1 mg, 2,5 mg and 5 mg E2006), capsule, orally in the morning, one hour after lights-on, on Day 1. | | OG001 | Part A: Placebo: Matched to 10, 25, 50, 100, 200 mg E2006 | Healthy participants received E2006-matched placebo (matched to 10 mg, 25 mg, 50 mg, 100 mg, and 200 mg E2006), capsule, orally in the morning, one hour after lights-on, on Day 1. |
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| Secondary | Part A: Maximum Change From Day 1 (Pre-dose) in Karolinska Sleepiness Scale (KSS) Score at Day 6 | 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. | 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. | Posted | | Mean | Standard Deviation | score on a scale | | Day 1 (Pre-dose), Day 6 | | | | ID | Title | Description |
|---|
| OG000 | Part A: Placebo: Matched to 1, 2.5, 5 mg E2006 | Healthy participants received E2006-matched placebo (matched to 1 mg, 2,5 mg and 5 mg E2006), capsule, orally in the morning, one hour after lights-on, on Day 1. | | OG001 | Part A: Placebo: Matched to 10, 25, 50, 100, 200 mg E2006 | Healthy participants received E2006-matched placebo (matched to 10 mg, 25 mg, 50 mg, 100 mg, and 200 mg E2006), capsule, orally in the morning, one hour after lights-on, on Day 1. | |
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| Secondary | Part A: Change From Day 1 in Waketime Questionnaire Parameters: How Long Did You Sleep Last Night at Day 6 | 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. | 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. | Posted | | Mean | Standard Deviation | minutes | | Day 1, Day 6 | | | | ID | Title | Description |
|---|
| OG000 | Part A: E2006 Matched Placebo | Healthy participants received E2006-matched placebo, capsule, orally in the morning, one hour after lights-on, on Day 1. | | OG001 | Part A: E2006 1.0 mg | Healthy participants received E2006 1 mg, capsule, orally in the morning, one hour after lights-on, on Day 1. | | OG002 | Part A: E2006 2.5 mg |
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| Secondary | Part A: Change From Day 1 in Waketime Questionnaire Parameters: Time to Fall Asleep Last Night at Day 6 | 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. | 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. | Posted | | Mean | Standard Deviation | minutes | | Day 1, Day 6 | | | | ID | Title | Description |
|---|
| OG000 | Part A: E2006 Matched Placebo | Healthy participants received E2006-matched placebo, capsule, orally in the morning, one hour after lights-on, on Day 1. | | OG001 | Part A: E2006 1.0 mg | Healthy participants received E2006 1 mg, capsule, orally in the morning, one hour after lights-on, on Day 1. | | OG002 | Part A: E2006 2.5 mg |
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| Secondary | Part A: Change From Day 1 in Waketime Questionnaire Parameters: Number of Awakening After Falling Asleep at Day 6 | 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. | 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. | Posted | | Mean | Standard Deviation | number of awakenings | | Day 1, Day 6 | | | | ID | Title | Description |
|---|
| OG000 | Part A: E2006 Matched Placebo | Healthy participants received E2006-matched placebo, capsule, orally in the morning, one hour after lights-on, on Day 1. | | OG001 | Part A: E2006 1.0 mg | Healthy participants received E2006 1 mg, capsule, orally in the morning, one hour after lights-on, on Day 1. | | OG002 |
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| Secondary | Part A: Change From Day 1 in Waketime Questionnaire Parameters: Time Spent Awake After Falling Asleep at Day 6 | 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. | 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. | Posted | | Mean | Standard Deviation | minutes | | Day 1, Day 6 | | | | ID | Title | Description |
|---|
| OG000 | Part A: E2006 Matched Placebo | Healthy participants received E2006-matched placebo, capsule, orally in the morning, one hour after lights-on, on Day 1. | | OG001 | Part A: E2006 1.0 mg | Healthy participants received E2006 1 mg, capsule, orally in the morning, one hour after lights-on, on Day 1. | | OG002 | Part A: E2006 2.5 mg |
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| Secondary | Part A: Change From Day 1 in Waketime Questionnaire Parameters: Rate Quality of Your Sleep at Day 6 | 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. | 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. | Posted | | Mean | Standard Deviation | score on a scale | | Day 1, Day 6 | | | | ID | Title | Description |
|---|
| OG000 | Part A: E2006 Matched Placebo | Healthy participants received E2006-matched placebo, capsule, orally in the morning, one hour after lights-on, on Day 1. | | OG001 | Part A: E2006 1.0 mg | Healthy participants received E2006 1 mg, capsule, orally in the morning, one hour after lights-on, on Day 1. | | OG002 | Part A: E2006 2.5 mg |
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| Secondary | Part B: Number of Participants With Treatment Emergent Adverse Events (AEs) and Treatment Emergent Serious Adverse Events (SAEs) | | Safety analysis set included all participants who received study drug and had at least one postdose safety assessment. | Posted | | Count of Participants | | Participants | | Baseline up to Day 11 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. | | OG003 | Part B: E2006 10 mg |
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| Secondary | Part B: Number of Participants With Markedly Abnormal Laboratory Parameter Values | | Safety analysis set included all participants who received study drug and had at least one postdose safety assessment. | Posted | | Count of Participants | | Participants | | Baseline up to Day 6 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. | | OG003 | Part B: E2006 10 mg | |
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| Secondary | Part B: Number of Participants With Significant Change From Baseline in Vital Sign Values | | Safety analysis set included all participants who received study drug and had at least one postdose safety assessment. | Posted | | Count of Participants | | Participants | | Baseline up to Day 11 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. | | OG003 | Part B: E2006 10 mg | |
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| Secondary | Part B: Number of Participants With Clinically Significant Change From Baseline in ECG Parameter Values | | Safety analysis set included all participants who received study drug and had at least one postdose safety assessment. | Posted | | Count of Participants | | Participants | | Baseline up to Day 11 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. | | OG003 | Part B: E2006 10 mg | |
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| Secondary | Part B: Number of Participants With Any Suicidality Assessed Using Columbia-Suicide Severity Rating Scale (C-SSRS) | 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. | Safety analysis set included all participants who received study drug and had at least one postdose safety assessment. | Posted | | Count of Participants | | Participants | | Baseline, Day 11 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | Part B: Zolpidem 10 mg | |
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