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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1256-7132 | Registry Identifier | WHO |
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The purpose of this study is to assess the safety and tolerability of TAK-994 and to determine the effect of TAK-994 (compared to placebo) on sleepiness, as measured by mean sleep latency on the maintenance of wakefulness Test (MWT), in an acute sleep phase delay paradigm in healthy participants.
The drug being tested in this study is called TAK-994. The study will evaluate the safety/tolerability, PD, and PK of TAK-994 in an acute sleep phase delay paradigm in healthy participants.
The study will enroll up to approximately 18 healthy participants. Participants will be randomly assigned to 1 of the 3 treatment sequences which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need):
This single center trial will be conducted in the United States. The overall time to participate in this study is approximately 10 weeks. Participants will be followed up remotely on Day 7 after the last dose of study drug for a follow-up assessment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TAK-994 Dose A+ Placebo + TAK-994 Dose B | Experimental | TAK-994 Dose A tablets, orally, on Days 1 and 2 of Treatment Period 1, followed by TAK-994 placebo-matching tablets, orally, on Days 1 and 2 of Treatment Period 2, further followed by TAK-994 Dose B tablets, orally, on Days 1 and 2 of Treatment Period 3. A Washout Period of at least 7 days will be maintained between each treatment period. |
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| TAK-994 Dose B + TAK-994 Dose A + Placebo | Experimental | TAK-994 Dose B tablets, orally, on Days 1 and 2 of Treatment Period 1, followed by TAK-994 Dose A tablets, orally, on Days 1 and 2 of Treatment Period 2, further followed by TAK-994 placebo-matching tablets, orally, on Days 1 and 2 of Treatment Period 3. A Washout Period of at least 7 days will be maintained between each treatment period. |
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| Placebo + TAK-994 Dose B+ TAK-994 Dose A | Experimental | TAK-994 placebo-matching tablets, orally, on Days 1 and 2 of Treatment Period 1, followed by TAK-994 Dose B tablets orally, on Days 1 and 2 of Treatment Period 2, further followed by TAK-994 Dose A tablets, orally, on Days 1 and 2 of Treatment Period 3. A Washout Period of at least 7 days will be maintained between each treatment period. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAK-994 | Drug | TAK-994 tablets. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants who Experience at Least 1 Treatment Emergent Adverse Event (TEAE) During the Study | From first dose of the study drug up to Day 7 after the last dose of study drug on Day 2 in Treatment Period 3 (up to Day 27) | |
| Number of Participants who Meet the Markedly Abnormal Value for Safety Laboratory Tests at Least Once Postdose During the Study | From first dose of the study drug up to Day 7 after the last dose of study drug on Day 2 in Treatment Period 3 (up to Day 27) | |
| Number of Participants who Meet the Markedly Abnormal Value for Vital Sign Measurements at Least Once Postdose During the Study | From first dose of the study drug up to Day 7 after the last dose of study drug on Day 2 in Treatment Period 3 (up to Day 27) | |
| Number of Participants who Meet the Markedly Abnormal Value for Safety Electrocardiogram (ECG) Parameters at Least Once Postdose During the Study | From first dose of the study drug up to Day 7 after the last dose of study drug on Day 2 in Treatment Period 3 (up to Day 27) | |
| Mean Sleep Latency Over Four Maintenance of Wakefulness Test (MWT) Sessions After Initial Dosing | MWT is a validated objective measure that evaluates a person's ability to remain awake under soporific conditions for a defined period of time. Tendency to fall asleep is measured via electroencephalography-derived sleep latency. Mean sleep latency: mean time to sleep onset, over 4 MWT sessions (at approximately 2, 4, 6, and 8 hours after initial dosing). | Up to 8 hours after initial dosing in each treatment period |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax: Maximum Observed Plasma Concentration for TAK-994 | Days 1 and 2: Pre-dose and at multiple time points (up to 10 hours) post-dose | |
| Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-994 | Days 1 and 2: Pre-dose and at multiple time points (up to 10 hours) post-dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinilabs Drug Development Corporation | New York | New York | 10019 | United States |
Takeda makes patient-level, de-identified data sets and associated documents available after applicable marketing approvals and commercial availability have been received, an opportunity for the primary publication of the research has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com/Approach for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.
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| Placebo | Drug | TAK-994 placebo-matching tablets. |
|
| AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-994 | Days 1 and 2: Pre-dose and at multiple time points (up to 10 hours) post-dose |
| Change From Baseline in Mean Karolinska Sleepiness Scale (KSS) Score | The KSS is a 10-item, Likert-type rating scale for assessing subjective sleepiness. This participant self-rating scale measures the subjective level of sleepiness at the time of administration. | Baseline up to 8.75 hours after initial dosing in each treatment period |