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Japanese Phase 1 Multiple Ascending Dose (MAD) Study

NCT01396252 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2013-06-10

No results posted yet for this study

Summary

The purpose of this clinical study is to assess the safety and tolerability of multiple oral doses of BMS-820836 in healthy Japanese subjects and Japanese patients with depression.

Conditions

Interventions

DRUG

BMS-820836

Tablets, Oral, 0.5 mg, Once daily, 14 days

DRUG

BMS-820836

Tablets, Oral, 1 mg, Once daily, 14 days

DRUG

BMS-820836

Tablets, Oral, 2 mg, Once daily, 14 days

DRUG

Placebo matching BMS-820836

Tablets, Oral, 0 mg, Once daily, 14 days

DRUG

BMS-820836

Tablets, Oral, (initiated at 1 mg and dose escalated to the target dose of 2 mg), Once daily, 14 days

Sponsors & Collaborators

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2012-05-31
Completion
2012-05-31

Countries

  • Japan

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Entities

Diseases
Companies

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 NCT01396252 on ClinicalTrials.gov