Trials / Terminated

TerminatedNCT02827513

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

Status: Terminated
Phase: Phase 1
Study type: Interventional
Enrollment: 16 (actual)

Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. · Industry
Sex: All
Age: 18 Years – 45 Years
Healthy volunteers: Accepted

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.

Detailed description

The study will be divided into three parts: A, B, C. Part A: Single Dose, extended release (XR) Formulation Selection. This part of the study is a single dose, open label, four-period crossover design in a group of 16 healthy participants. Part B: Multiple Ascending Dose. Part B has been designed to assess the effect of multiple doses of one formulation of XR CTN. This part of the study will be a double-blind, randomized, placebo-controlled design. Part C: Food Effect. Part C has been designed to determine the effect food has on XR CTN. The XR formulation and dose administered will be selected after review of Part B data. This part will be an open-label, two-period crossover design in a group of 16 healthy participants.

Conditions

Adult Attention-deficit Hyperactivity Disorder (ADHD)

Interventions

Type	Name	Description
DRUG	CTN SR1
DRUG	CTN XR1
DRUG	CTN XR2
DRUG	CTN XR3

Timeline

Start date: 2015-12-01
Primary completion: 2016-01-01
Completion: 2016-01-01
First posted: 2016-07-11
Last updated: 2022-02-18

Locations

1 site across 1 country: Australia

Source: ClinicalTrials.gov record NCT02827513. Inclusion in this directory is not an endorsement.