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NCT03522506 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of TAK-925 Study in Sleep-Deprived Healthy Adults
A Phase 1 study, sponsored by Takeda.
- Completed
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
NCT03522506: Completed Phase 1 study, sponsored by Takeda.
NCT03522506 is a Phase 1 study that has completed, run by Takeda. The registered enrollment target is 20 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03522506, a Phase 1 study, has completed, sponsored by Takeda.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
Study 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.
Primary Outcome
The MWT is a validated objective measure that evaluates a person's ability to remain awake under soporific conditions for a defined period of time. This tendency to fall asleep is measured via electroencephalography-derived sleep latency. Sleep onset is defined as the first epoch of greater than 15 seconds of cumulative sleep in a 30-second epoch. Trials were ended after 40 minutes if no sleep occurs, or after unequivocal sleep, defined as 3 consecutive epochs of stage 1 sleep, or 1 epoch of any
Interventions
- DRUG Modafinil
- DRUG Modafinil Placebo
- DRUG TAK-925
- DRUG TAK-925 Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2018-05-09 |
| Est. Completion | 2018-11-07 |
| Phase | Phase 1 |
What the finished NCT03522506 record still lists
NCT03522506 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower).
The record links to 0 conditions, and to 4 interventions - of which Modafinil is the first listed.
NCT03522506 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03522506 about?
NCT03522506 is a clinical study titled "A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of TAK-925 Study in Sleep-Deprived Healthy Adults". 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.
What is the current status of trial NCT03522506?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2018-05-09. Estimated completion is 2018-11-07.
What interventions are being tested in trial NCT03522506?
The interventions under investigation include: Modafinil (DRUG), Modafinil Placebo (DRUG), TAK-925 (DRUG), TAK-925 Placebo (DRUG).
Who is sponsoring clinical trial NCT03522506?
This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03522506's enrollment target sits among peer trials
20 1629th of 2000 higher than 285 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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