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TAK-653 Escalating Single and Multiple Dose Study in Healthy Participants

NCT02561156 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2021-03-03

Study results available
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Summary

The purpose of this study is to assess the safety, tolerability and pharmacokinetics (PK) of TAK-653 when administered as single and multiple oral doses at escalating dose levels in healthy participants.

Conditions

  • Depressive Disorder

Interventions

DRUG

TAK-653 Placebo

TAK-653 placebo-matching tablets.

DRUG

TAK-653

TAK-653 tablets.

Sponsors & Collaborators

  • Takeda

    collaborator INDUSTRY

  • Neurocrine Biosciences

    lead INDUSTRY

Principal Investigators

  • Medical Director · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2015-08-26
Primary Completion
2017-09-11
Completion
2017-09-23

Countries

  • United Kingdom

Study Locations

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Entities

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 NCT02561156 on ClinicalTrials.gov