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The main aim is to evaluate the relative abuse potential of soticlestat in healthy adults who has used central nervous system (CNS) depressants for recreational nontherapeutic reasons.
The drug being tested in this study is called soticlestat. Soticlestat is being tested in healthy participants. This study will assess the relative abuse potential of soticlestat compared to alprazolam and placebo in healthy adult, nondependent recreational drug users with CNS depressant experience. The study will enroll approximately 110 participants. Participants will be randomly (by chance, like flipping a coin) assigned to treatments of the study.
Treatment order will remain undisclosed to the participants and study doctor (unless there is an urgent medical need). This single center trial will be conducted in the United States. Participants will be followed up for up to 7 days after the last dose of study drug for a follow-up assessment. The overall time to participate in this study is approximately 11 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Soticlestat 300 mg | Experimental | Participants will receive a single oral dose of soticlestat 300 milligrams (mg). |
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| Soticlestat 600 mg | Experimental | Participants will receive a single oral dose of soticlestat 600 mg. |
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| Soticlestat 900 mg | Experimental | Participants will receive a single oral dose of soticlestat 900 mg. |
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| Alprazolam 2 mg | Active Comparator | Participants will receive a single oral dose of over encapsulated alprazolam 2 mg. |
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| Placebo | Placebo Comparator | Participants will receive a single oral dose of matching placebo. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Soticlestat 300 mg | Drug | Administered orally. |
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| Soticlestat 600 mg |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Phase: Drug Liking (Maximum Effect [Emax]) "At This Moment" as Assessed Using Bipolar Visual Analogue Scale (VAS) | Drug liking ("at this moment") assessed how much a participant likes or dislikes a drug effect at the time the question was being asked. It was scored using a 0 to 100-point bipolar VAS, where 0: Strong disliking, 50: Neither like nor dislike (neutral point), 100: Strong liking. A higher score indicates stronger liking. | Day 1 of each Treatment Period: 15, 30, and 45 minutes, and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, and 24 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Phase: Overall Drug Liking (Emax) Assessed Using Bipolar VAS | Overall drug liking assesses participant's overall experience with the drug by assessing the participant's overall liking for the drug. It was scored using a 100-point bipolar VAS, where 0: Strong disliking, 50: Neither like nor dislike (neutral point), 100: Strong liking. A higher score indicates better liking. The "overall drug liking" was an independent measure and not an "at this moment" assessment. |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Altasciences | Overland Park | Kansas | 66212 | United States |
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| Label | URL |
|---|---|
| To obtain more information on the study, click here/on this link. | View source |
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Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
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IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/ For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Participants entered a Qualification Phase to determine if they were able to discriminate the drug effects of the positive control, alprazolam, when compared with placebo. Only participants who could discriminate the drug effects of the positive control were randomized into one of the 10 sequences of Treatment Phase (ABECD, BCADE, CDBEA, DECAB, EADBC, DCEBA, EDACB, AEBDC, BACED or CBDAE) to receive soticlestat, alprazolam or placebo.
Participants took part in the study at 1 investigative site in the United States from 15 November 2022 to 07 July 2023. A total of 100 participants participated in the Qualification Phase, of which 69 met the qualification criteria, out of which 68 enrolled in the treatment phase and were randomized to 1 of the 10 sequences of the Treatment Phase.
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| ID | Title | Description |
|---|---|---|
| FG000 | Qualification Phase: Sequence 1 | All participants received: Day 1: Alprazolam 2 milligrams (mg), Day 2: Alprazolam matching placebo. Orally with a 4-day washout between Qualification Phase and Treatment Phase. |
| FG001 | Qualification Phase: Sequence 2 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Qualification Phase (3 Days) |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 15, 2023 | Jun 28, 2024 |
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| Drug |
Administered orally. |
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| Soticlestat 900 mg | Drug | Administered orally. |
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| Alprazolam | Drug | Administered orally. |
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| Placebo | Drug | Administered orally. |
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| Day 1 of each Treatment Period: 12 and 24 hours post-dose |
| Treatment Phase: Take Drug Again (Emax) Assessed "Overall" by Using Bipolar VAS | Take drug again was a subjective assessment of the degree to which a participant would desire to take the drug again if given the opportunity. It was scored using a 0 to 100-point bipolar VAS, where 0: Definitely not, 50: Neutral, 100: Definitely so. A higher score indicates stronger desire. | Day 1 of each Treatment Period: 12 and 24 hours post-dose |
| Treatment Phase: Bad Drug Effects (Emax) Assessed "At This Moment" by Using Unipolar VAS | Bad drug effects assessed the bad effect of drug experienced by the participant at the time the question is being asked. It was scored using a 100-point unipolar VAS, where responses were unidirectional and ranged from 0 (Not at all) to 100 (Extremely). A higher score indicated a stronger bad drug effect. | Day 1 of each Treatment Period: 15, 30, and 45 minutes, and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, and 24 hours post-dose |
| Treatment Phase: Good Drug Effects (Emax) Assessed "At This Moment" by Using Unipolar VAS | Good drug effects assessed the good effect of drug experienced by the participant at the time the question was being asked. It was scored using a 100-point unipolar VAS, where responses were unidirectional and range from 0 (Not at all) to 100 (extremely). A higher score indicated a stronger good drug effect. | Day 1 of each Treatment Period: 15, 30, and 45 minutes, and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, and 24 hours post-dose |
| Treatment Phase: High (Emax) Assessed "At This Moment" by Using Unipolar VAS | High assessed the degree that a participant feels a good effect (that is, euphoria) at the time the question was being asked. It was scored using a 100-point unipolar VAS, where responses were unidirectional and ranged from 0 (Not at all) to 100 (Extremely). A higher score indicated a stronger high effect. | Day 1 of each Treatment Period: 15, 30, and 45 minutes, and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, and 24 hours post-dose |
| Treatment Phase: Number of Participants With One or More Treatment-emergent Adverse Events (TEAEs) | An AE was defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A TEAE was defined as an adverse event that started or worsened during or after the first dose of study drug. | From start of study drug administration (Day 1) up to Day 37 |
All participants received: Day 1: Alprazolam matching placebo, Day 2: Alprazolam 2 mg. Orally with a 4-day washout between Qualification Phase and Treatment Phase. |
| FG002 | Treatment Phase, Sequence 1: ABECD | All participants received: Period 1: Soticlestat 300 milligrams (mg) (Treatment A), Period 2: Soticlestat 600 mg (Treatment B), Period 3: Placebo (Treatment E), Period 4: Soticlestat 900 mg (Treatment C), Period 5: Alprazolam 2 mg (Treatment D). Orally with a 7-day washout between doses. |
| FG003 | Treatment Phase, Sequence 2: BCADE | All participants received: Period 1: Soticlestat 600 mg (Treatment B), Period 2: Soticlestat 900 mg (Treatment C), Period 3: Soticlestat 300 mg (Treatment A), Period 4: Alprazolam 2 mg (Treatment D), Period 5: Placebo (Treatment E). Orally with a 7-day washout between doses. |
| FG004 | Treatment Phase, Sequence 3: CDBEA | All participants received: Period 1: Soticlestat 900 mg (Treatment C), Period 2: Alprazolam 2 mg (Treatment D), Period 3: Soticlestat 600 mg (Treatment B), Period 4: Placebo (Treatment E), Period 5: Soticlestat 300 mg (Treatment A). Orally with a 7-day washout between doses. |
| FG005 | Treatment Phase, Sequence 4: DECAB | Period 1: Alprazolam 2 mg (Treatment D), Period 2: Placebo (Treatment E), Period 3: Soticlestat 900 mg (Treatment C), Period 4: Soticlestat 300 mg (Treatment A), Period 5: Soticlestat 600 mg (Treatment B). Orally with a 7-day washout between doses. |
| FG006 | Treatment Phase, Sequence 5: EADBC | All participants received: Period 1: Placebo (Treatment E), Period 2: Soticlestat 300 mg (Treatment A), Period 3: Alprazolam 2 mg (Treatment D), Period 4: Soticlestat 600 mg (Treatment B), Period 5: Soticlestat 900 mg (Treatment C). Orally with a 7-day washout between doses. |
| FG007 | Treatment Phase, Sequence 6: DCEBA | All participants received: Period 1: Alprazolam 2 mg (Treatment D), Period 2: Soticlestat 900 mg (Treatment C), Period 3: Placebo, (Treatment E), Period 4: Soticlestat 600 mg, (Treatment B), Period 5: Soticlestat 300 mg (Treatment A). Orally with a 7-day washout between doses. |
| FG008 | Treatment Phase, Sequence 7: EDACB | All participants received: Period 1: Placebo (Treatment E), Period 2: Alprazolam 2 mg (Treatment D), Period 3: Soticlestat 300 mg (Treatment A), Period 4: Soticlestat 900 mg (Treatment C), Period 5: Soticlestat 600 mg (Treatment B). Orally with a 7-day washout between doses. |
| FG009 | Treatment Phase, Sequence 8: AEBDC | All participants received: Period 1: Soticlestat 300 mg (Treatment A), Period 2: Placebo (Treatment E), Period 3: Soticlestat 600 mg (Treatment B), Period 4: Alprazolam 2 mg (Treatment D), Period 5: Soticlestat 900 mg (Treatment C). Orally with a 7-day washout between doses. |
| FG010 | Treatment Phase, Sequence 9: BACED | All participants received: Period 1: Soticlestat 600 mg (Treatment B), Period 2: Soticlestat 300 mg (Treatment A), Period 3: Soticlestat 900 mg (Treatment C), Period 4: Placebo (Treatment E), Period 5: Alprazolam 2 mg (Treatment D). Orally with a 7-day washout between doses. |
| FG011 | Treatment Phase, Sequence 10: CBDAE | All participants received: Period 1: Soticlestat 900 mg (Treatment C), Period 2: Soticlestat 600 mg (Treatment B), Period 3: Alprazolam 2 mg (Treatment D), Period 4: Soticlestat 300 mg (Treatment A), Period 5: Placebo (Treatment E). Orally with a 7-day washout between doses. |
| Qualification Safety Analysis Set (Treated) |
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| COMPLETED |
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| NOT COMPLETED |
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| Treatment Phase (29 Days) |
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Qualification safety analysis set consists of all participants who received at least 1 dose of study drug in the qualification phase. As pre-specified in statistical analysis plan (SAP), the combined overall data for baseline measures were planned to be collected and reported for qualification phase.
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| ID | Title | Description |
|---|---|---|
| BG000 | Qualification Phase: All Participants | All participants who received at least 1 dose of study drug in the Qualification phase.: Sequence 1, Day 1: Alprazolam 2 mg, Day 2: Alprazolam matching placebo. Sequence 2, Day 1: Alprazolam matching placebo, Day 2: Alprazolam 2 mg. Orally with a 4-day washout between Qualification Phase and Treatment Phase. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Treatment Phase: Drug Liking (Maximum Effect [Emax]) "At This Moment" as Assessed Using Bipolar Visual Analogue Scale (VAS) | Drug liking ("at this moment") assessed how much a participant likes or dislikes a drug effect at the time the question was being asked. It was scored using a 0 to 100-point bipolar VAS, where 0: Strong disliking, 50: Neither like nor dislike (neutral point), 100: Strong liking. A higher score indicates stronger liking. | The Modified Completer Analysis Set consisted of all participants in the Completer Analysis Set, excluding those whose Drug Liking "at this moment" VAS Emax scores met the elimination criteria defined in the SAP. As pre-specified in SAP, the pharmacodynamic data was planned to be collected and reported as per the treatment dose. | Posted | Mean | Standard Error | score on a scale | Day 1 of each Treatment Period: 15, 30, and 45 minutes, and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, and 24 hours post-dose |
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| Secondary | Treatment Phase: Overall Drug Liking (Emax) Assessed Using Bipolar VAS | Overall drug liking assesses participant's overall experience with the drug by assessing the participant's overall liking for the drug. It was scored using a 100-point bipolar VAS, where 0: Strong disliking, 50: Neither like nor dislike (neutral point), 100: Strong liking. A higher score indicates better liking. The "overall drug liking" was an independent measure and not an "at this moment" assessment. | The Modified Completer Analysis Set consisted of all participants in the Completer Analysis Set, excluding those whose Drug Liking "at this moment" VAS Emax scores met the elimination criteria defined in the SAP. As pre-specified in SAP, the pharmacodynamic data was planned to be collected and reported as per the treatment dose. | Posted | Mean | Standard Error | score on a scale | Day 1 of each Treatment Period: 12 and 24 hours post-dose |
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| Secondary | Treatment Phase: Take Drug Again (Emax) Assessed "Overall" by Using Bipolar VAS | Take drug again was a subjective assessment of the degree to which a participant would desire to take the drug again if given the opportunity. It was scored using a 0 to 100-point bipolar VAS, where 0: Definitely not, 50: Neutral, 100: Definitely so. A higher score indicates stronger desire. | The Modified Completer Analysis Set consisted of all participants in the Completer Analysis Set, excluding those whose Drug Liking "at this moment" VAS Emax scores met the elimination criteria defined in the SAP. As pre-specified in SAP, the pharmacodynamic data was planned to be collected and reported as per the treatment dose. | Posted | Mean | Standard Error | score on a scale | Day 1 of each Treatment Period: 12 and 24 hours post-dose |
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| Secondary | Treatment Phase: Bad Drug Effects (Emax) Assessed "At This Moment" by Using Unipolar VAS | Bad drug effects assessed the bad effect of drug experienced by the participant at the time the question is being asked. It was scored using a 100-point unipolar VAS, where responses were unidirectional and ranged from 0 (Not at all) to 100 (Extremely). A higher score indicated a stronger bad drug effect. | The Modified Completer Analysis Set consisted of all participants in the Completer Analysis Set, excluding those whose Drug Liking "at this moment" VAS Emax scores met the elimination criteria defined in the SAP. As pre-specified in SAP, the pharmacodynamic data was planned to be collected and reported as per the treatment dose. | Posted | Mean | Standard Error | score on a scale | Day 1 of each Treatment Period: 15, 30, and 45 minutes, and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, and 24 hours post-dose |
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| Secondary | Treatment Phase: Good Drug Effects (Emax) Assessed "At This Moment" by Using Unipolar VAS | Good drug effects assessed the good effect of drug experienced by the participant at the time the question was being asked. It was scored using a 100-point unipolar VAS, where responses were unidirectional and range from 0 (Not at all) to 100 (extremely). A higher score indicated a stronger good drug effect. | The Modified Completer Analysis Set consisted of all participants in the Completer Analysis Set, excluding those whose Drug Liking "at this moment" VAS Emax scores met the elimination criteria defined in the SAP. As pre-specified in SAP, the pharmacodynamic data was planned to be collected and reported as per the treatment dose. | Posted | Mean | Standard Error | score on a scale | Day 1 of each Treatment Period: 15, 30, and 45 minutes, and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, and 24 hours post-dose |
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| Secondary | Treatment Phase: High (Emax) Assessed "At This Moment" by Using Unipolar VAS | High assessed the degree that a participant feels a good effect (that is, euphoria) at the time the question was being asked. It was scored using a 100-point unipolar VAS, where responses were unidirectional and ranged from 0 (Not at all) to 100 (Extremely). A higher score indicated a stronger high effect. | The Modified Completer Analysis Set consisted of all participants in the Completer Analysis Set, excluding those whose Drug Liking "at this moment" VAS Emax scores met the elimination criteria defined in the SAP. As pre-specified in SAP, the pharmacodynamic data was planned to be collected and reported as per the treatment dose. | Posted | Mean | Standard Error | score on a scale | Day 1 of each Treatment Period: 15, 30, and 45 minutes, and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, and 24 hours post-dose |
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| Secondary | Treatment Phase: Number of Participants With One or More Treatment-emergent Adverse Events (TEAEs) | An AE was defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A TEAE was defined as an adverse event that started or worsened during or after the first dose of study drug. | The Safety Analysis Set consisted of all participants who received at least 1 dose of study drug in the Treatment phase. As pre-specified in SAP, the safety data was planned to be collected and reported as per treatment dose. Here, "overall number of participants analyzed" signified participants who received the specified treatment. | Posted | Count of Participants | Participants | From start of study drug administration (Day 1) up to Day 37 |
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TEAEs are AEs that started after the first dose of study drug administration (Day 1) up to Day 3 for Qualification Phase and up to Day 37 for Treatment Phase
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. As pre-specified in SAP, the safety data was planned to be collected and reported as per treatment dose. Here, participants "at Risk" signified participants who received the specified treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Qualification Phase: Placebo | Alprazolam matching placebo orally, once on Day 1 or once on Day 2 in Qualification Phase. | 0 | 96 | 0 | 96 | 2 | 96 |
| EG001 | Qualification Phase: Alprazolam 2 mg | Alprazolam 2 mg, orally, once on Day 1 or once on Day 2 in Qualification Phase. | 0 | 98 | 0 | 98 | 83 | 98 |
| EG002 | Treatment Phase: Soticlestat 300 mg | Soticlestat 300 mg as a single oral dose in one of five treatment periods. | 0 | 63 | 0 | 63 | 14 | 63 |
| EG003 | Treatment Phase: Soticlestat 600 mg | Soticlestat 600 mg as a single oral dose in one of five treatment periods. | 0 | 63 | 0 | 63 | 10 | 63 |
| EG004 | Treatment Phase: Soticlestat 900 mg | Soticlestat 900 mg as a single oral dose in one of five treatment periods. | 0 | 61 | 0 | 61 | 9 | 61 |
| EG005 | Treatment Phase: Alprazolam 2 mg | Alprazolam 2 mg as a single oral dose in one of five treatment periods. | 0 | 59 | 0 | 59 | 50 | 59 |
| EG006 | Treatment Phase: Placebo | Placebo as a single oral dose in one of five treatment periods. | 0 | 62 | 0 | 62 | 8 | 62 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
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| Euphoric mood | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Takeda | +1-877-825-3327 | TrialDisclosures@takeda.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 10, 2023 | Jun 28, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| C000712808 | soticlestat |
| D000525 | Alprazolam |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Withdrawal by Subject |
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| Physician Decision |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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Soticlestat 900 mg as a single oral dose in one of five treatment periods.
| OG003 | Treatment Phase: Alprazolam 2 mg | Alprazolam 2 mg as a single oral dose in one of five treatment periods. |
| OG004 | Treatment Phase: Placebo | Placebo as a single oral dose in one of five treatment periods. |
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| OG003 | Treatment Phase: Alprazolam 2 mg | Alprazolam 2 mg as a single oral dose in one of five treatment periods. |
| OG004 | Treatment Phase: Placebo | Placebo as a single oral dose in one of five treatment periods. |
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Soticlestat 900 mg as a single oral dose in one of five treatment periods.
| OG003 | Treatment Phase: Alprazolam 2 mg | Alprazolam 2 mg as a single oral dose in one of five treatment periods. |
| OG004 | Treatment Phase: Placebo | Placebo as a single oral dose in one of five treatment periods. |
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Soticlestat 900 mg as a single oral dose in one of five treatment periods.
| OG003 | Treatment Phase: Alprazolam 2 mg | Alprazolam 2 mg as a single oral dose in one of five treatment periods. |
| OG004 | Treatment Phase: Placebo | Placebo as a single oral dose in one of five treatment periods. |
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| OG003 | Treatment Phase: Alprazolam 2 mg | Alprazolam 2 mg as a single oral dose in one of five treatment periods. |
| OG004 | Treatment Phase: Placebo | Placebo as a single oral dose in one of five treatment periods. |
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| OG003 | Treatment Phase: Alprazolam 2 mg | Alprazolam 2 mg as a single oral dose in one of five treatment periods. |
| OG004 | Treatment Phase: Placebo | Placebo as a single oral dose in one of five treatment periods. |
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