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A Multiple Ascending Oral Dose Evaluation of the Safety, Tolerability, and Pharmacokinetics of DSP-1053 and Its Metabolites in Healthy Subjects and in Subjects With Major Depressive Disorder — MAD  

Healthy Clinical Trial

Official title:
A Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Oral Dose Study to Evaluate Safety, Tolerability, and Pharmacokinetics of DSP-1053 in Healthy Subjects and in Subjects With Major Depressive Disorder

Clinical Trial Summary

Double-blind, placebo-controlled, multiple ascending oral dose evaluation of the safety, tolerability, and pharmacokinetics of DSP 1053 and its metabolites in healthy subjects and in subjects with major depressive disorder

Clinical Trial Description

This study will be conducted at a single site as a double-blind, placebo-controlled, mulitple ascending oral doses evaluation of the safety, tolerability, and pharmacokinetics of DSP-1053 and its metabolites in healthy subjects with Major depressive disorder after the minimumally intolerated dose is reached in healthy subjects ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01774747
Study type Interventional
Source Sunovion
Contact
Status Terminated
Phase Phase 1
Start date December 2012
Completion date April 2014
View Details
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