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NCT01879722 · ClinicalTrials.gov registry record · Phase 1
Safety, Tolerability and Pharmacokinetic Study of Multiple Rising Doses of TAK- 063 in Participants With Stable Schizophrenia and Healthy Participants
A Phase 1 study, sponsored by Takeda.
- Completed
- Registry status
- Phase 1
- Development phase
- 77
- Enrollment target
NCT01879722: Completed Phase 1 study, sponsored by Takeda.
NCT01879722 is a Phase 1 study that has completed, run by Takeda. The registered enrollment target is 77 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (28% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01879722, a Phase 1 study, has completed, sponsored by Takeda.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 77 participants
- Enrollment target
Study Summary
The purpose of this study is to characterize the safety and tolerability of TAK-063 when administered as multiple oral doses at escalating dose levels in participants with stable schizophrenia and in healthy Japanese participants.
Primary Outcome
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined
Interventions
- DRUG TAK-063
- DRUG TAK-063 Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 77 participants |
| Start Date | 2013-06 |
| Est. Completion | 2014-06 |
| Phase | Phase 1 |
What the finished NCT01879722 record still lists
NCT01879722 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 77 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (28% higher).
The record links to 0 conditions, and to 2 interventions - of which TAK-063 is the first listed.
NCT01879722 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01879722 about?
NCT01879722 is a clinical study titled "Safety, Tolerability and Pharmacokinetic Study of Multiple Rising Doses of TAK- 063 in Participants With Stable Schizophrenia and Healthy Participants". The purpose of this study is to characterize the safety and tolerability of TAK-063 when administered as multiple oral doses at escalating dose levels in participants with stable schizophrenia and in healthy Japanese participants.
What is the current status of trial NCT01879722?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 77 participants. The study started on 2013-06. Estimated completion is 2014-06.
What interventions are being tested in trial NCT01879722?
The interventions under investigation include: TAK-063 (DRUG), TAK-063 Placebo (DRUG).
Who is sponsoring clinical trial NCT01879722?
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 NCT01879722's enrollment target sits among peer trials
77 703rd of 2000 higher than 1,296 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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