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Phase 1 TAK-041 First-in-Human Safety, Tolerability, and Pharmacokinetics Study

NCT02748694 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 114

Last updated 2021-03-19

Study results available
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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

Interventions

DRUG

TAK-041

TAK-041 tablets or oral suspension.

DRUG

TAK-041 Placebo

TAK-041 placebo-matching suspension or tablet.

Sponsors & Collaborators

  • Takeda

    collaborator INDUSTRY

  • Neurocrine Biosciences

    lead INDUSTRY

Principal Investigators

  • Medical Director Clinical Science · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-05-09
Primary Completion
2019-09-22
Completion
2019-09-22
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02748694 on ClinicalTrials.gov