MedTrace Logo

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

NCT01774747 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 47

Last updated 2014-06-18

No results posted yet for this study

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

Conditions

  • Healthy

Interventions

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

Sponsors & Collaborators

  • Sumitomo Pharma America, Inc.

    lead INDUSTRY

Principal Investigators

  • Medical Director, DSP-1053 · Sumitomo Pharma America, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2014-04-30
Completion
2014-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT01774747 on ClinicalTrials.gov