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Phase 1 TAK-041 First-in-Human Safety, Tolerability, and Pharmacokinetics Study
NCT02748694 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02748694
The ClinicalTrials.gov registry entry for NCT02748694 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 114 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Neurocrine Biosciences, which has 47 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02748694 reports 1 study location spanning 1 distinct geographic area — top geographies include California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02748694?
The interventions under investigation include: TAK-041 (DRUG), TAK-041 Placebo (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02748694?
This trial is sponsored by Neurocrine Biosciences, which has 47 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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