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): * TAK-994 Dose A + Placebo + TAK-994 Dose B * TAK-994 Dose B + TAK-994 Dose A + Placebo * Placebo + TAK-994 Dose B + TAK-994 Dose A 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
19
Clinilabs Drug Development Corporation
New York, New York, United States
Number of Participants who Experience at Least 1 Treatment Emergent Adverse Event (TEAE) During the Study
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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).
Time frame: Up to 8 hours after initial dosing in each treatment period
Cmax: Maximum Observed Plasma Concentration for TAK-994
Time frame: Days 1 and 2: Pre-dose and at multiple time points (up to 10 hours) post-dose
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Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-994
Time frame: Days 1 and 2: Pre-dose and at multiple time points (up to 10 hours) post-dose
AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-994
Time frame: 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.
Time frame: Baseline up to 8.75 hours after initial dosing in each treatment period