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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1221-3144 | Other Identifier | WHO | |
| JapicCTI-184207 | Registry Identifier | JapicCTI |
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The purpose of this study is to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of TAK-925 when administered to healthy participants and narcolepsy participants.
The drug being tested in this study is called TAK-925. TAK-925 is being tested in healthy participants and participants with narcolepsy. This study will look at the safety, tolerability, pharmacokinetics, and efficacy of TAK-925.
This study will consist of three parts. Part A will be a randomized, double-blind, placebo-controlled, multiple rising dose (MRD) study in healthy participants. Part B is a randomized, double-blind, placebo-controlled MRD study in participants with narcolepsy. Part C is a randomized, double-blind, placebo-controlled, parallel group, multiple repeat dose study in participants with narcolepsy. Part A' is a single dose study in healthy participants.
The study will enroll approximately 96 participants planned as total. All participants except Part A' will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups-which will remain undisclosed to the participants and study doctor during the study (unless there is an urgent medical need):
Part A:
Part B:
Part C:
Part A':
• TAK-925 (Dose Levels A'1-A'2)
All participants will be asked to take TAK-925 or Placebo at the same time each day from Day 1 to Day 7 in Parts A, B and C, and take TAK-925 on Day 1 in Part A'.
This multi-center trial will be conducted in Japan. The overall study period is approximately 15 days in Parts A, B and C, and approximately 7 days for Part A'. Participants will be partly admitted to a hospital during the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A1; TAK-925 (Dose Level A1) | Experimental | TAK-925, Dose Level A, once daily for up to 7 days in healthy participants. |
|
| Cohort A2; TAK-925 (Dose Level A2) | Experimental | TAK-925, Dose Level A2, once daily for up to 7 days in healthy participants. Dose level will be determined based on the data of safety, tolerability and PK data from previous cohorts. |
|
| Cohort A3; TAK-925 (Dose Level A3) | Experimental | TAK-925, Dose Level A3, once daily for up to 7 days in healthy participants. This group is an additional optional cohort and dose level will be determined based on the data of safety, tolerability and PK data from previous cohorts. |
|
| Cohort A4; TAK-925 (Dose Level A4) | Experimental | TAK-925, Dose Level A4, once daily for up to 7 days in healthy participants. This group is an additional optional cohort and dose level will be determined based on the data of safety, tolerability and PK data from previous cohorts. |
|
| Cohort A5; TAK-925 (Dose Level A5) | Experimental | TAK-925, Dose Level A5, once daily for up to 7 days in healthy participants. This group is an additional optional cohort and dose level will be determined based on the data of safety, tolerability and PK data from previous cohorts. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAK-925 | Drug | TAK-925 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) | An Adverse Event (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. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE was defined as an AE with an onset that occurs after receiving study drug. | From the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) |
| Measure | Description | Time Frame |
|---|---|---|
| Parts A, B and C; Ceoi: Observed Plasma Concentration at the End of Infusion for TAK-925 | This assessment was pre-specified to be conducted for participants in "Part A', Cohort A'1: TAK-925 112 mg" as exploratory measures. | Part A,Days 1,7:pre-infusion(inf),0.5,1, 1.5, 2, 4, 6, 8, 9 hours(h)post start of inf;0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 6, 10, 15 h post end of inf;Part B,C:Days 1,7:Pre-inf, 1, 2, 4, 6, 9 h post start of inf; 0.17, 0.5, 2, 6, 10, 15 h post end of inf |
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Inclusion Criteria:
Healthy adult participants and Healthy elderly participants:
• Participant weighs at least 50 kg (Healthy adults participants) / 40 kilogram (kg) (Healthy elderly participants) and has a body mass index (BMI) from 18.5 to 30 kilogram per square meter (kg/m^2), inclusive at Screening.
Narcolepsy participants:
Exclusion Criteria:
All Participants:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sumida Hospital | Sumida-ku | Tokyo | Japan | |||
| Hakata Clinic |
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 Part A and A' (exploratory), NT1 in Part B and NT2 in Part C, to receive TAK-925 multiple rising dose of 44 mg (milligram), 112 mg,180 mg or placebo in Part A, 11 mg, 44 mg or placebo in Part B, multiple dose of TAK-925 44 mg, 112 mg or placebo in Part C.
Participants took part in the study at 3 investigative sites in Japan from 21 November 2018 to 24 October 2019.
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| ID | Title | Description |
|---|---|---|
| FG000 | Part A, Cohorts A1-A3: Pooled Placebo | TAK-925 placebo-matching, infusion, intravenously, once daily from Day 1 through Day 7 in healthy participants. |
| FG001 | Part A, Cohort A1: TAK-925 44 mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 28, 2019 | Oct 23, 2020 |
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|
| Cohort A6; TAK-925 (Dose Level A6) | Experimental | TAK-925, Dose Level A6, once daily for up to 7 days in healthy elderly participants. This group is an additional optional cohort and dose level will be determined based on the data of safety, tolerability and PK data from previous cohorts. |
|
| Part A (Cohorts A1-A6); TAK-925 Placebo | Placebo Comparator | TAK-925 Placebo, once daily for up to 7 days in healthy participants. |
|
| Cohort B1; TAK-925 (Dose Level B1) | Experimental | TAK-925, Dose Level B1, once daily for up to 7 days in participants with narcolepsy. |
|
| Cohort B2; TAK-925 (Dose Level B2) | Experimental | TAK-925, Dose Level B2, once daily for up to 7 days in participants with narcolepsy. Dose level will be determined based on the data of safety, tolerability and PK data from previous cohorts. |
|
| Cohort B3; TAK-925 (Dose Level B3) | Experimental | TAK-925, Dose Level B3, once daily for up to 7 days in participants with narcolepsy. This group is an additional optional cohort and dose level will be determined based on the data of safety, tolerability and PK data from previous cohorts. |
|
| Cohort B4; TAK-925 (Dose Level B4) | Experimental | TAK-925, Dose Level B4, once daily for up to 7 days in participants with narcolepsy. This group is an additional optional cohort and dose level will be determined based on the data of safety, tolerability and PK data from previous cohorts. |
|
| Part B (Cohorts B1-B4); TAK-925 Placebo | Placebo Comparator | TAK-925 Placebo, once daily for up to 7 days in participants with narcolepsy. |
|
| Cohort C1; TAK-925 (Dose Level C1) | Experimental | TAK-925, Dose Level C1, once daily for up to 7 days in participants with narcolepsy. Dose level will be determined based on the data of safety, tolerability and PK data from previous cohorts. |
|
| Cohort C2; TAK-925 (Dose Level C2) | Experimental | TAK-925, Dose Level C2, once daily for up to 7 days in participants with narcolepsy. This group is an additional optional cohort and dose level will be determined based on the data of safety, tolerability and PK data from previous cohorts. |
|
| Part C (Cohorts C1-C2); TAK-925 Placebo | Placebo Comparator | TAK-925 Placebo, once daily for up to 7 days in participants with narcolepsy. |
|
| Cohort A'1; TAK-925 (Dose Level A'1) | Experimental | TAK-925, Dose Level A'1, single dose in healthy participants. |
|
| Cohort A'2; TAK-925 (Dose Level A'2) | Experimental | TAK-925, Dose Level A'2, single dose in healthy participants. Dose level will be determined based on the data of safety, tolerability and PK data from previous cohorts. |
|
| Placebo | Drug | TAK-925 Placebo |
|
| Parts A, B and C; AUCtau: Area Under the Plasma Concentration-Time Curve During a Dosing Interval for TAK-925 | This assessment was pre-specified to be conducted for participants in "Part A', Cohort A'1: TAK-925 112 mg" as exploratory measures. | Part A,Days 1,7:pre-infusion(inf),0.5,1, 1.5, 2, 4, 6, 8, 9 hours(h)post start of inf;0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 6, 10, 15 h post end of inf;Part B,C:Days 1,7:Pre-inf, 1, 2, 4, 6, 9 h post start of inf; 0.17, 0.5, 2, 6, 10, 15 h post end of inf |
| Parts A, B and C; Rac (AUC): Accumulation Ratio Based on AUCtau for TAK-925 | Accumulation Ratio of AUC was calculated as AUCtau on Day 7 divided by AUCtau on Day 1. This assessment was pre-specified to be conducted for participants in "Part A', Cohort A'1: TAK-925 112 mg" as exploratory measures. | Part A,Days 1,7:pre-infusion(inf),0.5,1, 1.5, 2, 4, 6, 8, 9 hours(h)post start of inf;0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 6, 10, 15 h post end of inf;Part B,C:Days 1,7:Pre-inf, 1, 2, 4, 6, 9 h post start of inf; 0.17, 0.5, 2, 6, 10, 15 h post end of inf |
| Parts B and C: Change From Baseline in Sleep Latency in the Maintenance of Wakefulness Test (MWT) at Days 1 and 7 | The MWT is a validated objective measure that is used to measure excessive daytime sleepiness in clinical studies. It has been used as a secondary outcome measure for excessive daytime sleepiness. The MWT evaluates a person's ability to remain awake under soporific conditions for a defined period of time. Wakefulness in this study was measured indirectly by time to fall asleep using MWT. In this study, four 40-minute (1 session) MWT assessments per day was administered on Baseline, Day 1 and Day 7. MWT sleep latency ranges from 0 to 40 minutes, with longer sleep latency indicating greater ability to stay awake. | Baseline, Day 1 and Day 7 |
| Fukuoka |
| Japan |
| PS Clinic | Fukuoka | Japan |
TAK-925 44 mg, infusion, intravenously, once daily from Day 1 through Day 7 in healthy participants.
| FG002 | Part A, Cohort A2: TAK-925 112 mg | TAK-925 112 mg, infusion, intravenously, once daily from Day 1 through Day 7 in healthy participants. |
| FG003 | Part A, Cohort A3: TAK-925 180 mg | TAK-925 180 mg, infusion, intravenously, once daily from Day 1 through Day 7 in healthy participants. |
| FG004 | Part B, Cohorts B1-B2: Pooled Placebo | TAK-925 placebo-matching, infusion, intravenously, once daily from Day 1 through Day 7 in narcolepsy type 1 (NT1) participants. |
| FG005 | Part B, Cohort B1: TAK-925 11 mg | TAK-925 11 mg, infusion, intravenously, once daily from Day 1 through Day 7 in NT1 participants. |
| FG006 | Part B, Cohort B2: TAK-925 44 mg | TAK-925 44 mg, infusion, intravenously, once daily from Day 1 through Day 7 in NT1 participants. |
| FG007 | Part C, Cohorts C1-C2: Pooled Placebo | TAK-925 placebo-matching, infusion, intravenously, once daily from Day 1 through Day 7 in narcolepsy type 2 (NT2) participants. |
| FG008 | Part C, Cohort C1: TAK-925 44 mg | TAK-925 44 mg, infusion, intravenously, once daily from Day 1 through Day 7 in NT2 participants. |
| FG009 | Part C, Cohort C2: TAK-925 112 mg | TAK-925 112 mg, infusion, intravenously, once daily from Day 1 through Day 7 in NT2 participants. |
| FG010 | Part A', Cohort A'1: TAK-925 112 mg | TAK-925 112 mg, solution, orally, once on Day 1 in healthy participants. |
| COMPLETED |
|
| NOT COMPLETED |
|
The safety set was defined as all participants who received at least one dose of study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Part A, Cohorts A1-A3: Pooled Placebo | TAK-925 placebo-matching, infusion, intravenously, once daily from Day 1 through Day 7 in healthy participants. |
| BG001 | Part A, Cohort A1: TAK-925 44 mg | TAK-925 44 mg, infusion, intravenously, once daily from Day 1 through Day 7 in healthy participants. |
| BG002 | Part A, Cohort A2: TAK-925 112 mg | TAK-925 112 mg, infusion, intravenously, once daily from Day 1 through Day 7 in healthy participants. |
| BG003 | Part A, Cohort A3: TAK-925 180 mg | TAK-925 180 mg, infusion, intravenously, once daily from Day 1 through Day 7 in healthy participants. |
| BG004 | Part B, Cohorts B1-B2: Pooled Placebo | TAK-925 placebo-matching, infusion, intravenously, once daily from Day 1 through Day 7 in NT1 participants. |
| BG005 | Part B, Cohort B1: TAK-925 11 mg | TAK-925 11 mg, infusion, intravenously, once daily from Day 1 through Day 7 in NT1 participants. |
| BG006 | Part B, Cohort B2: TAK-925 44 mg | TAK-925 44 mg, infusion, intravenously, once daily from Day 1 through Day 7 in NT1 participants. |
| BG007 | Part C, Cohorts C1-C2: Pooled Placebo | TAK-925 placebo-matching, infusion, intravenously, once daily from Day 1 through Day 7 in NT2 participants. |
| BG008 | Part C, Cohort C1: TAK-925 44 mg | TAK-925 44 mg, infusion, intravenously, once daily from Day 1 through Day 7 in NT2 participants. |
| BG009 | Part C, Cohort C2: TAK-925 112 mg | TAK-925 112 mg, infusion, intravenously, once daily from Day 1 through Day 7 in NT2 participants. |
| BG010 | Part A', Cohort A'1: TAK-925 112 mg | TAK-925 112 mg, solution, orally, once on Day 1 in healthy participants. |
| BG011 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
| ||||||||||
| Region of Enrollment | Count of Participants | Participants |
| |||||||||||
| Body Mass Index (BMI) | Mean | Standard Deviation | kilogram per square meter (kg/m˄2) |
| ||||||||||
| Height | Mean | Standard Deviation | centimeter (cm) |
| ||||||||||
| Weight | Mean | Standard Deviation | kilogram (kg) |
|
| 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 | Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) | An Adverse Event (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. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE was defined as an AE with an onset that occurs after receiving study drug. | The safety set was defined as all participants who received at least one dose of study drug. | Posted | Count of Participants | Participants | From the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15) |
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Parts A, B and C; Ceoi: Observed Plasma Concentration at the End of Infusion for TAK-925 | This assessment was pre-specified to be conducted for participants in "Part A', Cohort A'1: TAK-925 112 mg" as exploratory measures. | The pharmacokinetic (PK) set was defined as all participants who received at least one dose of study drug and provided sufficient PK measurements available to estimate PK parameters, at least 1 estimable PK parameter. | Posted | Geometric Mean | Standard Deviation | nanogram per milliliter (ng/mL) | Part A,Days 1,7:pre-infusion(inf),0.5,1, 1.5, 2, 4, 6, 8, 9 hours(h)post start of inf;0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 6, 10, 15 h post end of inf;Part B,C:Days 1,7:Pre-inf, 1, 2, 4, 6, 9 h post start of inf; 0.17, 0.5, 2, 6, 10, 15 h post end of inf |
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| Secondary | Parts A, B and C; AUCtau: Area Under the Plasma Concentration-Time Curve During a Dosing Interval for TAK-925 | This assessment was pre-specified to be conducted for participants in "Part A', Cohort A'1: TAK-925 112 mg" as exploratory measures. | The PK set was defined as all participants who received at least one dose of study drug and provided sufficient PK measurements available to estimate PK parameters, at least 1 estimable PK parameter. | Posted | Geometric Mean | Standard Deviation | hour*nanogram per milliliter (h*ng/mL) | Part A,Days 1,7:pre-infusion(inf),0.5,1, 1.5, 2, 4, 6, 8, 9 hours(h)post start of inf;0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 6, 10, 15 h post end of inf;Part B,C:Days 1,7:Pre-inf, 1, 2, 4, 6, 9 h post start of inf; 0.17, 0.5, 2, 6, 10, 15 h post end of inf |
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| Secondary | Parts A, B and C; Rac (AUC): Accumulation Ratio Based on AUCtau for TAK-925 | Accumulation Ratio of AUC was calculated as AUCtau on Day 7 divided by AUCtau on Day 1. This assessment was pre-specified to be conducted for participants in "Part A', Cohort A'1: TAK-925 112 mg" as exploratory measures. | The PK set was defined as all participants who received at least one dose of study drug and provided sufficient PK measurements available to estimate PK parameters, at least 1 estimable PK parameter. | Posted | Mean | Standard Deviation | ratio | Part A,Days 1,7:pre-infusion(inf),0.5,1, 1.5, 2, 4, 6, 8, 9 hours(h)post start of inf;0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 6, 10, 15 h post end of inf;Part B,C:Days 1,7:Pre-inf, 1, 2, 4, 6, 9 h post start of inf; 0.17, 0.5, 2, 6, 10, 15 h post end of inf |
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| Secondary | Parts B and C: Change From Baseline in Sleep Latency in the Maintenance of Wakefulness Test (MWT) at Days 1 and 7 | The MWT is a validated objective measure that is used to measure excessive daytime sleepiness in clinical studies. It has been used as a secondary outcome measure for excessive daytime sleepiness. The MWT evaluates a person's ability to remain awake under soporific conditions for a defined period of time. Wakefulness in this study was measured indirectly by time to fall asleep using MWT. In this study, four 40-minute (1 session) MWT assessments per day was administered on Baseline, Day 1 and Day 7. MWT sleep latency ranges from 0 to 40 minutes, with longer sleep latency indicating greater ability to stay awake. | The pharmacodynamic (PD) set was defined as all participants who received at least one dose of study drug. Here number analyzed "n" are the participants who were evaluable for the outcome measure at given time points. | Posted | Mean | Standard Deviation | minutes | Baseline, Day 1 and Day 7 |
|
TEAEs are adverse events (AEs) that started after the first dose of study drug up to 7 days after the last dose of study drug (up to Day 15)
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Part A, Cohorts A1-A3: Pooled Placebo | TAK-925 placebo-matching, infusion, intravenously, once daily from Day 1 through Day 7 in healthy participants. | 0 | 6 | 0 | 6 | 1 | 6 |
| EG001 | Part A, Cohort A1: TAK-925 44 mg | TAK-925 44 mg, infusion, intravenously, once daily from Day 1 through Day 7 in healthy participants. | 0 | 6 | 0 | 6 | 0 | 6 |
| EG002 | Part A, Cohort A2: TAK-925 112 mg | TAK-925 112 mg, infusion, intravenously, once daily from Day 1 through Day 7 in healthy participants. | 0 | 6 | 0 | 6 | 2 | 6 |
| EG003 | Part A, Cohort A3: TAK-925 180 mg | TAK-925 180 mg, infusion, intravenously, once daily from Day 1 through Day 7 in healthy participants. | 0 | 6 | 0 | 6 | 4 | 6 |
| EG004 | Part B, Cohorts B1-B2: Pooled Placebo | TAK-925 placebo-matching, infusion, intravenously, once daily from Day 1 through Day 7 in NT1 participants. | 0 | 4 | 0 | 4 | 1 | 4 |
| EG005 | Part B, Cohort B1: TAK-925 11 mg | TAK-925 11 mg, infusion, intravenously, once daily from Day 1 through Day 7 in NT1 participants. | 0 | 4 | 0 | 4 | 1 | 4 |
| EG006 | Part B, Cohort B2: TAK-925 44 mg | TAK-925 44 mg, infusion, intravenously, once daily from Day 1 through Day 7 in NT1 participants. | 0 | 5 | 0 | 5 | 5 | 5 |
| EG007 | Part C, Cohorts C1-C2: Pooled Placebo | TAK-925 placebo-matching, infusion, intravenously, once daily from Day 1 through Day 7 in NT2 participants. | 0 | 5 | 0 | 5 | 0 | 5 |
| EG008 | Part C, Cohort C1: TAK-925 44 mg | TAK-925 44 mg, infusion, intravenously, once daily from Day 1 through Day 7 in NT2 participants. | 0 | 4 | 0 | 4 | 1 | 4 |
| EG009 | Part C, Cohort C2: TAK-925 112 mg | TAK-925 112 mg, infusion, intravenously, once daily from Day 1 through Day 7 in NT2 participants. | 0 | 5 | 0 | 5 | 3 | 5 |
| EG010 | Part A', Cohort A'1: TAK-925 112 mg | TAK-925 112 mg, solution, orally, once on Day 1 in healthy participants. | 0 | 6 | 0 | 6 | 0 | 6 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Salivary hypersecretion | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Feeling abnormal | General disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA (22.0) | 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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical director | Takeda | +1-877-825-3327 | trialdisclosures@takeda.com |
| SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Jun 12, 2019 | Dec 2, 2020 | Prot_001.pdf |
| ID | Term |
|---|---|
| D009290 | Narcolepsy |
| ID | Term |
|---|---|
| D006970 | Disorders of Excessive Somnolence |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| C000729607 | TAK-925 |
Not provided
Not provided
Not provided
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| OG003 | Part B, Cohort B1: TAK-925 11 mg | TAK-925 11 mg, infusion, intravenously, once daily from Day 1 through Day 7 in NT1 participants. |
| OG004 | Part B, Cohort B2: TAK-925 44 mg | TAK-925 44 mg, infusion, intravenously, once daily from Day 1 through Day 7 in NT1 participants. |
| OG005 | Part C, Cohort C1: TAK-925 44 mg | TAK-925 44 mg, infusion, intravenously, once daily from Day 1 through Day 7 in NT2 participants. |
| OG006 | Part C, Cohort C2: TAK-925 112 mg | TAK-925 112 mg, infusion, intravenously, once daily from Day 1 through Day 7 in NT2 participants. |
|
|
| OG003 | Part B, Cohort B1: TAK-925 11 mg | TAK-925 11 mg, infusion, intravenously, once daily from Day 1 through Day 7 in NT1 participants. |
| OG004 | Part B, Cohort B2: TAK-925 44 mg | TAK-925 44 mg, infusion, intravenously, once daily from Day 1 through Day 7 in NT1 participants. |
| OG005 | Part C, Cohort C1: TAK-925 44 mg | TAK-925 44 mg, infusion, intravenously, once daily from Day 1 through Day 7 in NT2 participants. |
| OG006 | Part C, Cohort C2: TAK-925 112 mg | TAK-925 112 mg, infusion, intravenously, once daily from Day 1 through Day 7 in NT2 participants. |
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| OG003 | Part B, Cohort B1: TAK-925 11 mg | TAK-925 11 mg, infusion, intravenously, once daily from Day 1 through Day 7 in NT1 participants. |
| OG004 | Part B, Cohort B2: TAK-925 44 mg | TAK-925 44 mg, infusion, intravenously, once daily from Day 1 through Day 7 in NT1 participants. |
| OG005 | Part C, Cohort C1: TAK-925 44 mg | TAK-925 44 mg, infusion, intravenously, once daily from Day 1 through Day 7 in NT2 participants. |
| OG006 | Part C, Cohort C2: TAK-925 112 mg | TAK-925 112 mg, infusion, intravenously, once daily from Day 1 through Day 7 in NT2 participants. |
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| Part B, Cohort B2: TAK-925 44 mg |
TAK-925 44 mg, infusion, intravenously, once daily from Day 1 through Day 7 in NT1 participants. |
| OG003 | Part C, Cohorts C1-C2: Pooled Placebo | TAK-925 placebo-matching, infusion, intravenously, once daily from Day 1 through Day 7 in NT2 participants. |
| OG004 | Part C, Cohort C1: TAK-925 44 mg | TAK-925 44 mg, infusion, intravenously, once daily from Day 1 through Day 7 in NT2 participants. |
| OG005 | Part C, Cohort C2: TAK-925 112 mg | TAK-925 112 mg, infusion, intravenously, once daily from Day 1 through Day 7 in NT2 participants. |
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