NCT01774747

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

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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: Sumitomo Pharma America, Inc. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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

Detailed 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

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	DSP-1053	DSP-1053 10, 15, 20, 30, 45, 60, 90 mg once daily for 14 days
DRUG	Placebo	Placebo 10, 15, 20, 30, 45, 60, 90 mg once daily for 14 days

Timeline

• Start date: 2012-12-01
• Primary completion: 2014-04-01
• Completion: 2014-04-01
• First posted: 2013-01-24
• Last updated: 2014-06-18

Locations

1 site across 1 country: United States