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NCT04551079 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics (PK) of Oral TAK-994 in an Acute Sleep Phase Delay Paradigm in Healthy Male Participants
A Phase 1 study of Healthy Volunteers, sponsored by Takeda.
- Completed
- Registry status
- Phase 1
- Development phase
- 19
- Enrollment target
- 1
- Study location
NCT04551079: Completed Phase 1 study of Healthy Volunteers, sponsored by Takeda.
NCT04551079 is a Phase 1 study of Healthy Volunteers that has completed, run by Takeda. The registered enrollment target is 19 participants, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04551079, a Phase 1 study of Healthy Volunteers, has completed, sponsored by Takeda.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 19 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG TAK-994
Study Locations (1)
New York
- Clinilabs Drug Development Corporation - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2020-09-23 |
| Est. Completion | 2020-12-31 |
| Phase | Phase 1 |
What the finished NCT04551079 record still lists
NCT04551079 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Healthy Volunteers appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04551079 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT04551079 about?
NCT04551079 is a clinical study titled "A Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics (PK) of Oral TAK-994 in an Acute Sleep Phase Delay Paradigm in Healthy Male Participants". 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.
What is the current status of trial NCT04551079?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 19 participants. The study started on 2020-09-23. Estimated completion is 2020-12-31.
What conditions does trial NCT04551079 study?
This clinical trial studies the following conditions: Healthy Volunteers.
What interventions are being tested in trial NCT04551079?
The interventions under investigation include: Placebo (DRUG), TAK-994 (DRUG).
Who is sponsoring clinical trial NCT04551079?
This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04551079 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Healthy Volunteers
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04551079's enrollment target sits among peer trials
19 226th of 283 higher than 56 of 283 other Healthy Volunteers trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy Volunteers 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.
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