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NCT02748694 · ClinicalTrials.gov registry record · Phase 1
Phase 1 TAK-041 First-in-Human Safety, Tolerability, and Pharmacokinetics Study
A Phase 1 study of Schizophrenia and Healthy Volunteers, sponsored by Neurocrine Biosciences.
- Completed
- Registry status
- Phase 1
- Development phase
- 114
- Enrollment target
- 1
- Study location
NCT02748694: Completed Phase 1 study of Schizophrenia and Healthy Volunteers, sponsored by Neurocrine Biosciences.
NCT02748694 is a Phase 1 study of Schizophrenia and Healthy Volunteers that has completed, run by Neurocrine Biosciences. The registered enrollment target is 114 participants, below the 219-participant average among 315 other Schizophrenia trials with a reported enrollment target (48% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02748694, a Phase 1 study of Schizophrenia and Healthy Volunteers, has completed, sponsored by Neurocrine Biosciences.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 114 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of TAK-041: 1. Following oral single and multiple doses in healthy participants. 2. As add-on therapy to antipsychotics in stable schizophrenia participants. 3. To determine the oral bioavailability of the TAK-041 tablet formulation compared to the oral suspension formulation in the fasted state. 4. To assess the effect of food on the PK of TAK-041 in healthy participants.
Primary Outcome
An AE was defined as any untoward medical occurrence in a clinical investigation participant administered a drug or due to a study procedure; it did not necessarily have to have a causal relationship with this treatment. A TEAE was defined as an AE that occurred or worsened after receiving the first dose of study drug and within 6 weeks after the last dose of study drug. A TEAE may also have been a pre-treatment AE or a concurrent medical condition diagnosed before the date of first dose of stud
Conditions Studied
Interventions
- DRUG TAK-041
- DRUG TAK-041 Placebo
Study Locations (1)
California
- Parexel Early Phase Clinic Unit- Los Angeles - Glendale
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 114 participants |
| Start Date | 2016-05-09 |
| Est. Completion | 2019-09-22 |
| Phase | Phase 1 |
What the finished NCT02748694 record still lists
NCT02748694 is an interventional study that assigns participants to a tested intervention. The registered 114 participants enrollment target is mid-sized for trials with a published cap, below the 219-participant average among 315 other Schizophrenia trials with a reported enrollment target (48% lower).
The record links to 2 conditions, with Schizophrenia appearing as the primary indexed condition, and to 2 interventions - of which TAK-041 is the first listed.
NCT02748694 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT02748694 about?
NCT02748694 is a clinical study titled "Phase 1 TAK-041 First-in-Human Safety, Tolerability, and Pharmacokinetics Study". The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of TAK-041: 1. Following oral single and multiple doses in healthy participants. 2. As add-on therapy to antipsychotics in stable schizophrenia participants. 3. To determine the oral bioavailability of the ...
What is the current status of trial NCT02748694?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 114 participants. The study started on 2016-05-09. Estimated completion is 2019-09-22.
What conditions does trial NCT02748694 study?
This clinical trial studies the following conditions: Schizophrenia, Healthy Volunteers.
What interventions are being tested in trial NCT02748694?
The interventions under investigation include: TAK-041 (DRUG), TAK-041 Placebo (DRUG).
Who is sponsoring clinical trial NCT02748694?
This trial is sponsored by Neurocrine Biosciences, which has 65 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02748694 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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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 NCT02748694's enrollment target sits among peer trials
114 128th of 315 higher than 188 of 315 other Schizophrenia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Schizophrenia 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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