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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 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.

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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.

Interventions

  • DRUG TAK-041
  • DRUG TAK-041 Placebo

Study Locations (1)

California

  • Parexel Early Phase Clinic Unit- Los Angeles - Glendale

Trial Details

FieldValue
Enrollment Target 114 participants
Start Date 2016-05-09
Est. Completion 2019-09-22
Phase Phase 1

Sponsor

Neurocrine Biosciences

65 total trials

What the Registry Record Tells You About NCT02748694

The ClinicalTrials.gov registry entry for NCT02748694 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 114 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 219-participant average among 315 other Schizophrenia trials with a reported enrollment target (48% lower). The listed sponsor is Neurocrine Biosciences, which has 65 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.