At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 20 enrolled
Drug / intervention
TAK-925 +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 1b, 4-Period Crossover, Placebo-Controlled, Randomized, Single Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of TAK-925 in Sleep-Deprived Healthy Adults Utilizing Modafinil as an Active Comparator
In Brief
A Phase 1 clinical trial evaluating TAK-925, TAK-925 Placebo, and 2 other interventions for Healthy Volunteers. Completed, enrolled 20 participants across 1 site.
Detailed Summary
The purpose of this study is to determine the effect of TAK-925 after a single intravenous dose (compared to placebo) on promoting wakefulness as measured by sleep latency on the maintenance of wakefulness (MWT) in sleep-deprived healthy participants.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Volunteers
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
20192020202120222023202420252026
Enrollment StartMay 2018
First PostedMay 2018
Primary CompletionNov 2018
TodayJul 2026
First PostedMay 11, 2018
Enrollment StartMay 9, 2018
Primary CompletionNov 7, 2018
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 8.1 years ago
Interventions
TAK-925drug
TAK-925 intravenous infusion.
TAK-925 Placebodrug
TAK-925 placebo-matching given as saline intravenous infusion.
Modafinildrug
Modafinil tablets.
Modafinil Placebodrug
Modafinil placebo-matching tablet.