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A Phase 1 Study to Investigate the Safety, Tolerance, Food Effect, Pharmacokinetics and Pharmacodynamics of Single and Multiple Doses of Extended Release Formulations of Centanafadine (CTN) in Young Healthy Subjects

NCT02827513 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2022-02-18

No results posted yet for this study

Summary

The purpose of this study is to investigate the safety, tolerance, food effect, pharmacokinetics (PK) and pharmacodynamics (PD) of single and multiple doses of extended release (XR) formulations of Centanafadine (CTN) in Young Healthy participants.

Conditions

  • Adult Attention-deficit Hyperactivity Disorder (ADHD)

Interventions

DRUG

CTN SR1

DRUG

CTN XR1

DRUG

CTN XR2

DRUG

CTN XR3

Sponsors & Collaborators

  • Otsuka Pharmaceutical Development & Commercialization, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2016-01-31
Completion
2016-01-31

Countries

  • Australia

Study Locations

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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 NCT02827513 on ClinicalTrials.gov