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The main aim of this study is to check how itraconazole and mefenamic acid affect the way soticlestat is processed by the body.
The study will have 2 parts. Participants can only participate in one study part.
Part 1: Participants will check into the study clinic to receive soticlestat, four days later they will begin receiving itraconazole and will stay in the clinic for 11 more days, receiving soticlestat in combination with itraconazole on one of those days. Participants will be contacted about 8 days after leaving the clinic for follow-up.
Part 2: Participants will check into the study clinic to receive soticlestat, four days later they will begin receiving mefenamic acid and will stay in the clinic for 7 more days, receiving soticlestat in combination with mefenamic acid on one of those days.. Participants will be contacted about 9 days after leaving the clinic for follow-up.
The drug being tested in this study is called soticlestat (TAK-935). The study will evaluate the safety and tolerability of soticlestat when co-administered with either itraconazole or mefenamic acid in healthy participants.
The study will be conducted in 2 parts: Part 1 (drug-drug interaction [DDI] with itraconazole), Part 2 (DDI with mefenamic acid). The study will enroll approximately 28 participants. Participants will be enrolled into two parts (Part 1 and Part 2) to receive soticlestat along with adjunctive therapy itraconazole and mefenamic acid as:
Both Parts 1 and 2 will have two period (Periods 1 and 2). In Period 1, participants will receive only soticlestat (study drug) and in Period 2, participants will receive study drug along with either itraconazole or mefenamic acid depending upon in which part they are in. The data will be collected and stored in electronic case report form (eCRF).
This single-center trial will be conducted in the United States. The overall duration of the study is approximately 52 days for participants in Part 1 (includes screening and follow-up), but 48 days for participants in Part 2 (including screening and follow-up). There will be follow up for all participants approximately 15 days after the last dose of soticlestat in each study part.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: Soticlestat 300 mg + Itraconazole 200 mg | Experimental | Soticlestat 300 milligram (mg), tablets, orally, once on Day 1 in Period 1, followed by 4 days washout period, followed by itraconazole 200 mg solution, orally, once daily from Day 1 up to Day 11, further followed by soticlestat 300 mg tablet, orally along with itraconazole 200 mg solution, orally on the morning of Day in Period 2. |
|
| Part 2: Soticlestat 300 mg + Mefenamic Acid 500 mg | Experimental | Soticlestat 300 mg, tablets, orally, once on Day 1 in Period 1, followed by 4 days washout period, followed by single dose of mefenamic acid 500 mg capsule (first dose only), orally on the morning of Day 1 and 250 mg subsequent doses at every six hours up to Day 7 in Period 2, further followed by soticlestat 300 mg tablet, orally, followed by mefenamic acid 250 mg capsule, orally in morning of Day 2 in Period 2. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Soticlestat | Drug | Soticlestat tablets. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part 1, Cmax: Maximum Observed Plasma Concentration for Soticlestat When Administered Alone and With Itraconazole | Soticlestat alone: Period 1, Day 1 pre-dose and at multiple timepoints (up to 96 hours) post-dose; Soticlestat with itraconazole: Period 2, Day 5 pre-dose and at multiple timepoints (up to 168 hours) post-dose | |
| Part 2, Cmax: Maximum Observed Plasma Concentration for Soticlestat When Administered Alone and With Mefenamic Acid | Soticlestat alone: Period 1, Day 1 pre-dose and at multiple timepoints (up to 96 hours) post-dose; Soticlestat with mefenamic acid: Period 2, Day 2 pre-dose and at multiple timepoints (up to 144 hours) post-dose | |
| Part 1, AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Soticlestat When Administered Alone and With Itraconazole | Soticlestat alone: Period 1, Day 1 pre-dose and at multiple timepoints (up to 96 hours) post-dose; Soticlestat with itraconazole: Period 2, Day 5 pre-dose and at multiple timepoints (up to 168 hours) post-dose | |
| Part 2, AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Soticlestat When Administered Alone and With Mefenamic Acid | Soticlestat alone: Period 1, Day 1 pre-dose and at multiple timepoints (up to 96 hours) post-dose; Soticlestat with mefenamic acid: Period 2, Day 2 pre-dose and at multiple timepoints (up to 144 hours) post-dose | |
| Part 1, AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Soticlestat When Administered Alone and With Itraconazole | Soticlestat alone: Period 1, Day 1 pre-dose and at multiple timepoints (up to 96 hours) post-dose; Soticlestat with itraconazole: Period 2, Day 5 pre-dose and at multiple timepoints (up to 168 hours) post-dose | |
| Part 2, AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Soticlestat When Administered Alone and With Mefenamic Acid |
| Measure | Description | Time Frame |
|---|---|---|
| Parts 1 and 2: Number of Participants Reported One or More Treatment-emergent Adverse Event (TEAE) | Part 1: from Day 1 of Period 1 up to 15 days after the last dose of soticlestat in Period 2 (up to Day 20 in Period 2); Part 2: from Day 1 of Period 1 up to 15 days after the last dose of soticlestat in Period 2 (up to Day 17 in Period 2) | |
| Parts 1 and 2: Number of Participants With Clinically Significant Abnormal Values for Laboratory Evaluations |
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Inclusion Criteria:
Has body mass index (BMI) greater than or equal to (>=) 18.0 and less than or equal to (<=) 32.0 kilogram per meter square (kg/m^2) at screening.
Continuous non-smoker who has not used nicotine-containing products for at least 90 days prior to the first dosing.
Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs or electrocardiograms (ECGs), as deemed by the Investigator or designee.
Able to swallow multiple tablets.
Exclusion Criteria:
Has history of any illness that, in the opinion of the Investigator or designee, might confound the results of the study or poses an additional risk to the participants by their participation in the study.
Has history or presence of alcoholism or drug abuse within the past 2 years prior to the first dosing.
Has history or presence of hypersensitivity or idiosyncratic reaction to the study drugs or related compounds.
Unable to refrain from or anticipates the use of:
• Any drug, including prescription and non-prescription medications, herbal remedies, or vitamin supplements within 14 days prior to the first dosing. Thyroid hormone replacement medication may be permitted if the participant has been on the same stable dose for the immediate 3 months prior to first dosing.
Has history of alcohol consumption exceeding 2 standard drinks per day on average (1 glass is approximately equivalent to the following: beer 354 milliliter (mL)/12 Ounce [oz], wine [118 mL/4 oz], or distilled spirits [29.5 mL/1 oz] per day).
Consumes excessive amounts, defined as greater than 4 servings (1 serving is approximately equivalent to 120 mg of caffeine), of coffee, tea, cola, energy drinks, or other caffeinated beverages per day.
Has been on a diet incompatible with the on-study diet, in the opinion of the Investigator or designee, within the 30 days prior to the first dosing and throughout the study.
Donation of blood or significant blood loss within 56 days prior to the first dosing.
Plasma donation within 7 days prior to the first dosing.
Has participation in another clinical study within 30 days or 5 half-lives prior to the first dosing. The 30-day window or 5 half-lives will be derived from the date of the last blood collection or dosing, whichever is later, in the previous study to Day 1 of Period 1 of the current study.
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Celerion | Lincoln | Nebraska | 68502 | 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.
Healthy participants were enrolled in this 2-part study to receive soticlestat tablets alone in Period 1 and soticlestat tablets and itraconazole solution in Period 2 of Part 1; and soticlestat tablets alone in Period 1 and soticlestat tablets and mefenamic acid capsules in Period 2 of Part 2. Both study parts (Parts 1 and 2) were conducted independently from one another, no crossover happened between both parts.
Participants took part in the study at 1 investigative site in the United States from 14 October 2021 to 30 November 2021.
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| ID | Title | Description |
|---|---|---|
| FG000 | Part 1: Soticlestat 300 mg + Itraconazole 200 mg | Soticlestat 300 milligram (mg) administered as 3*100 mg tablets, orally, once on Day 1 of Period 1, followed by 4 days washout period, further followed by itraconazole 200 mg administered as 20 milliliter (mL) of 10 milligram per milliliter (mg/ml) solution, orally, once daily from Day 1 up to Day 11 of Period 2 and soticlestat 300 mg administered as 3*100 mg tablets, orally, once on Day 5 of Period 2. |
| FG001 | Part 2: Soticlestat 300 mg + Mefenamic Acid 500 mg and 250 mg | Soticlestat 300 mg administered as 3*100 mg tablets, orally, once on Day 1 of Period 1, followed by 4 days washout period, further followed by initial single dose of mefenamic acid 500 mg administered as 2*250 mg capsules, orally on the morning of Day 1 and 250 mg subsequent doses at every six hours from Day 1 up to Day 7 of Period 2, and soticlestat 300 mg administered as 3*100 mg tablets, orally, once on Day 2 of Period 2. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 (1 Day) |
| |||||||||||||
| Washout Period (4 Days) |
| |||||||||||||
| Period 2(Part 1:Day 1-12;Part 2:Day 1-8) |
|
All participants who received at least one dose of the study drug(s) were included in the safety analysis set.
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| ID | Title | Description |
|---|---|---|
| BG000 | Part 1: Soticlestat 300 mg + Itraconazole 200 mg | Soticlestat 300 mg administered as 3*100 mg tablets, orally, once on Day 1 of Period 1, followed by 4 days washout period, further followed by itraconazole 200 mg administered as 20 mL of 10 mg/ml solution, orally, once daily from Day 1 up to Day 11 of Period 2 and soticlestat 300 mg administered as 3*100 mg tablets, orally, once on Day 5 of Period 2. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Part 1, Cmax: Maximum Observed Plasma Concentration for Soticlestat When Administered Alone and With Itraconazole | All participants who complied sufficiently with the protocol and display an evaluable pharmacokinetic (PK) profile (example, exposure to treatment, availability of measurements and absence of major protocol violations) were included in the PK analysis set. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram per milliliter (ng/mL) | Soticlestat alone: Period 1, Day 1 pre-dose and at multiple timepoints (up to 96 hours) post-dose; Soticlestat with itraconazole: Period 2, Day 5 pre-dose and at multiple timepoints (up to 168 hours) post-dose |
|
TEAEs were adverse events (AE) that started from Day 1 of Period 1 up to 15 days after the last dose of soticlestat in Period 2 (up to Day 20 of Period 2) in Part 1; and from Day 1 of Period 1 up to 15 days after the last dose of soticlestat in Period 2 (up to Day 17 of Period 2) in Part 2
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.
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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 | Part 1: Soticlestat 300 mg Alone | Soticlestat 300 mg administered as 3*100 mg tablets, orally, once on Day 1 of Period 1. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Takeda | +1-877-825-3327 | TrialDisclosures@takeda.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 23, 2021 | Nov 24, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 15, 2021 | Nov 24, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C000712808 | soticlestat |
| D017964 | Itraconazole |
| D008528 | Mefenamic Acid |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Itraconazole | Drug | Itraconazole oral solution. |
|
| Mefenamic acid | Drug | Mefenamic acid capsule. |
|
| Soticlestat alone: Period 1, Day 1 pre-dose and at multiple timepoints (up to 96 hours) post-dose; Soticlestat with mefenamic acid: Period 2, Day 2 pre-dose and at multiple timepoints (up to 144 hours) post-dose |
| Part 1, Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Soticlestat When Administered Alone and With Itraconazole | Soticlestat alone: Period 1, Day 1 pre-dose and at multiple timepoints (up to 96 hours) post-dose; Soticlestat with itraconazole: Period 2, Day 5 pre-dose and at multiple timepoints (up to 168 hours) post-dose |
| Part 2, Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Soticlestat When Administered Alone and With Mefenamic Acid | Soticlestat alone: Period 1, Day 1 pre-dose and at multiple timepoints (up to 96 hours) post-dose; Soticlestat with mefenamic acid: Period 2, Day 2 pre-dose and at multiple timepoints (up to 144 hours) post-dose |
| Part 1: Day 1 of Period 1 up to Day 12 of Period 2; Part 2: Day 1 of Period 1 up to Day 8 of Period 2 |
| Parts 1 and 2: Number of Participants With Clinically Significant Abnormal Values for Vital Signs | Part 1: Day 1 of Period 1 up to Day 12 of Period 2; Part 2: Day 1 of Period 1 up to Day 8 of Period 2 |
| Parts 1 and 2: Number of Participants With Clinically Significant Abnormal Values for Electrocardiogram (ECG) | Part 1: Day 1 of Period 1 up to Day 12 of Period 2; Part 2: Day 1 of Period 1 up to Day 8 of Period 2 |
| Parts 1 and 2: Number of Participants With Suicidal Ideation or Suicidal Behavior as Measured Using Columbia-Suicide Severity Rating Scale (C-SSRS) | The C-SSRS is an interview-based rating scale to systematically assess any suicidality, suicidal behavior, or suicidal ideation. Any suicidality is emergence of any suicidal ideation or suicidal behavior. Any suicidal behavior was indicated when response was "yes" for any these questions- actual attempted to suicide, engaged in non-suicidal self-injurious behavior, interrupted attempt, aborted attempt, preparatory acts. Any suicidal ideation was indicated when response was "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 intended to act, without specific plan or with specific plan and intended to suicide. | Part 1: Day 1 of Period 1 up to Day 12 of Period 2; Part 2: Day 1 of Period 1 up to Day 8 of Period 2 |
| NOT COMPLETED |
|
| NOT COMPLETED |
|
| BG001 | Part 2: Soticlestat 300 mg + Mefenamic Acid 500 mg and 250 mg | Soticlestat 300 mg administered as 3*100 mg tablets, orally, once on Day 1 of Period 1, followed by 4 days washout period, further followed by initial single dose of mefenamic acid 500 mg administered as 2*250 mg capsules, orally on the morning of Day 1 and 250 mg subsequent doses at every six hours from Day 1 up to Day 7 of Period 2, and soticlestat 300 mg administered as 3*100 mg tablets, orally, once on Day 2 of Period 2. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Part 1: Soticlestat 300 mg + Itraconazole 200 mg |
Itraconazole 200 mg administered as 20 mL of 10 mg/ml solution, orally, once daily from Day 1 up to Day 11 of Period 2, and soticlestat 300 mg administered as 3*100 mg tablets, orally, once on Day 5 of Period 2. |
|
|
|
| Primary | Part 2, Cmax: Maximum Observed Plasma Concentration for Soticlestat When Administered Alone and With Mefenamic Acid | All participants who complied sufficiently with the protocol and display an evaluable PK profile (example, exposure to treatment, availability of measurements and absence of major protocol violations) were included in the PK analysis set. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Soticlestat alone: Period 1, Day 1 pre-dose and at multiple timepoints (up to 96 hours) post-dose; Soticlestat with mefenamic acid: Period 2, Day 2 pre-dose and at multiple timepoints (up to 144 hours) post-dose |
|
|
|
|
| Primary | Part 1, AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Soticlestat When Administered Alone and With Itraconazole | All participants who complied sufficiently with the protocol and display an evaluable PK profile (example, exposure to treatment, availability of measurements and absence of major protocol violations) were included in the PK analysis set. Here, "overall number of participants analyzed" signified those who were evaluable for this outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram*hours per milliliter(ng*hr/mL) | Soticlestat alone: Period 1, Day 1 pre-dose and at multiple timepoints (up to 96 hours) post-dose; Soticlestat with itraconazole: Period 2, Day 5 pre-dose and at multiple timepoints (up to 168 hours) post-dose |
|
|
|
|
| Primary | Part 2, AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Soticlestat When Administered Alone and With Mefenamic Acid | All participants who complied sufficiently with the protocol and display an evaluable PK profile (example, exposure to treatment, availability of measurements and absence of major protocol violations) were included in the PK analysis set. Here, "overall number of participants analyzed" signified those who were evaluable for this outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | Soticlestat alone: Period 1, Day 1 pre-dose and at multiple timepoints (up to 96 hours) post-dose; Soticlestat with mefenamic acid: Period 2, Day 2 pre-dose and at multiple timepoints (up to 144 hours) post-dose |
|
|
|
|
| Primary | Part 1, AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Soticlestat When Administered Alone and With Itraconazole | All participants who complied sufficiently with the protocol and display an evaluable PK profile (example, exposure to treatment, availability of measurements and absence of major protocol violations) were included in the PK analysis set. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | Soticlestat alone: Period 1, Day 1 pre-dose and at multiple timepoints (up to 96 hours) post-dose; Soticlestat with itraconazole: Period 2, Day 5 pre-dose and at multiple timepoints (up to 168 hours) post-dose |
|
|
|
|
| Primary | Part 2, AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Soticlestat When Administered Alone and With Mefenamic Acid | All participants who complied sufficiently with the protocol and display an evaluable PK profile (example, exposure to treatment, availability of measurements and absence of major protocol violations) were included in the PK analysis set. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | Soticlestat alone: Period 1, Day 1 pre-dose and at multiple timepoints (up to 96 hours) post-dose; Soticlestat with mefenamic acid: Period 2, Day 2 pre-dose and at multiple timepoints (up to 144 hours) post-dose |
|
|
|
|
| Primary | Part 1, Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Soticlestat When Administered Alone and With Itraconazole | All participants who complied sufficiently with the protocol and display an evaluable PK profile (example, exposure to treatment, availability of measurements and absence of major protocol violations) were included in the PK analysis set. | Posted | Median | Full Range | hour | Soticlestat alone: Period 1, Day 1 pre-dose and at multiple timepoints (up to 96 hours) post-dose; Soticlestat with itraconazole: Period 2, Day 5 pre-dose and at multiple timepoints (up to 168 hours) post-dose |
|
|
|
|
| Primary | Part 2, Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Soticlestat When Administered Alone and With Mefenamic Acid | All participants who complied sufficiently with the protocol and display an evaluable PK profile (example, exposure to treatment, availability of measurements and absence of major protocol violations) were included in the PK analysis set. | Posted | Median | Full Range | hour | Soticlestat alone: Period 1, Day 1 pre-dose and at multiple timepoints (up to 96 hours) post-dose; Soticlestat with mefenamic acid: Period 2, Day 2 pre-dose and at multiple timepoints (up to 144 hours) post-dose |
|
|
|
|
| Secondary | Parts 1 and 2: Number of Participants Reported One or More Treatment-emergent Adverse Event (TEAE) | All participants who received at least one dose of the study drug(s) were included in the safety analysis set. | Posted | Count of Participants | Participants | Part 1: from Day 1 of Period 1 up to 15 days after the last dose of soticlestat in Period 2 (up to Day 20 in Period 2); Part 2: from Day 1 of Period 1 up to 15 days after the last dose of soticlestat in Period 2 (up to Day 17 in Period 2) |
|
|
|
| Secondary | Parts 1 and 2: Number of Participants With Clinically Significant Abnormal Values for Laboratory Evaluations | All participants who received at least one dose of the study drug(s) were included in the safety analysis set. | Posted | Count of Participants | Participants | Part 1: Day 1 of Period 1 up to Day 12 of Period 2; Part 2: Day 1 of Period 1 up to Day 8 of Period 2 |
|
|
|
| Secondary | Parts 1 and 2: Number of Participants With Clinically Significant Abnormal Values for Vital Signs | All participants who received at least one dose of the study drug(s) were included in the safety analysis set. | Posted | Count of Participants | Participants | Part 1: Day 1 of Period 1 up to Day 12 of Period 2; Part 2: Day 1 of Period 1 up to Day 8 of Period 2 |
|
|
|
| Secondary | Parts 1 and 2: Number of Participants With Clinically Significant Abnormal Values for Electrocardiogram (ECG) | All participants who received at least one dose of the study drug(s) were included in the safety analysis set. | Posted | Count of Participants | Participants | Part 1: Day 1 of Period 1 up to Day 12 of Period 2; Part 2: Day 1 of Period 1 up to Day 8 of Period 2 |
|
|
|
| Secondary | Parts 1 and 2: Number of Participants With Suicidal Ideation or Suicidal Behavior as Measured Using Columbia-Suicide Severity Rating Scale (C-SSRS) | The C-SSRS is an interview-based rating scale to systematically assess any suicidality, suicidal behavior, or suicidal ideation. Any suicidality is emergence of any suicidal ideation or suicidal behavior. Any suicidal behavior was indicated when response was "yes" for any these questions- actual attempted to suicide, engaged in non-suicidal self-injurious behavior, interrupted attempt, aborted attempt, preparatory acts. Any suicidal ideation was indicated when response was "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 intended to act, without specific plan or with specific plan and intended to suicide. | All participants who received at least one dose of the study drug(s) were included in the safety analysis set. | Posted | Count of Participants | Participants | Part 1: Day 1 of Period 1 up to Day 12 of Period 2; Part 2: Day 1 of Period 1 up to Day 8 of Period 2 |
|
|
|
| 0 |
| 14 |
| 0 |
| 14 |
| 1 |
| 14 |
| EG001 | Part 1: Itraconazole 200 mg Alone | Itraconazole 200 mg administered as 20 mL of 10 mg/ml solution, orally, once daily from Day 1 up to Day 11 of Period 2. | 0 | 14 | 0 | 14 | 2 | 14 |
| EG002 | Part 1: Soticlestat 300 mg + Itraconazole 200 mg | Soticlestat 300 mg administered as 3*100 mg tablets, orally, once on Day 1 of Period 1, followed by 4 days washout period, further followed by itraconazole 200 mg administered as 20 mL of 10 mg/ml solution, orally, once daily from Day 1 up to Day 11 of Period 2 and soticlestat 300 mg administered as 3*100 mg tablets, orally, once on Day 5 of Period 2. | 0 | 14 | 0 | 14 | 3 | 14 |
| EG003 | Part 2: Soticlestat 300 mg Alone | Soticlestat 300 mg administered as 3*100 mg tablets, orally, once on Day 1 of Period 1. | 0 | 14 | 0 | 14 | 1 | 14 |
| EG004 | Part 2: Mefenamic Acid 500 mg and 250 mg | Initial single dose of mefenamic acid 500 mg administered as 2*250 mg capsules, orally on the morning of Day 1 and 250 mg subsequent doses at every six hours from Day 1 up to Day 7 of Period 2. | 0 | 14 | 0 | 14 | 0 | 14 |
| EG005 | Part 2: Soticlestat 300 mg + Mefenamic Acid 500 mg and 250 mg | Soticlestat 300 mg administered as 3*100 mg tablets, orally, once on Day 1 of Period 1, followed by 4 days washout period, further followed by initial single dose of mefenamic acid 500 mg administered as 2*250 mg capsules, orally on the morning of Day 1 and 250 mg subsequent doses at every six hours from Day 1 up to Day 7 of Period 2, and soticlestat 300 mg administered as 3*100 mg tablets, orally, once on Day 2 of Period 2. | 0 | 14 | 0 | 14 | 3 | 14 |
| Chest discomfort | General disorders | MedDRA 24.1 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 24.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 24.1 | Systematic Assessment |
|
| Feeling hot | General disorders | MedDRA 24.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
|
| Limb injury | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
|
| Nasal dryness | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA 24.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
Research Organization shall not publish any articles or papers nor make any presentations, nor assist any other person in publishing any articles or papers or in making any presentations relating or referring to the Study or any results, data or insights from or any data, information or materials obtained or generated in the performance of its obligations without the prior written consent of Takeda, which consent may be granted or withheld in Takeda's sole discretion.
| D010879 |
| Piperazines |
| D054361 | Fenamates |
| D062367 | ortho-Aminobenzoates |
| D062365 | Aminobenzoates |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |