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Japanese Phase 1 Multiple Ascending Dose Study

NCT01515202 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2012-12-05

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-823778 in healthy Japanese subjects and Japanese patients with Type 2 Diabetes Mellitus.

Conditions

Interventions

DRUG

BMS-823778

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

DRUG

BMS-823778

Capsules, Oral, 12 mg, Once daily, 14 days

DRUG

BMS-823778

Capsules, Oral, 25 mg, Once daily, 14 days

DRUG

BMS-823778

Capsules, Oral, 15 mg, Once daily, 14 days

DRUG

Placebo matching with BMS-823778

Capsules, Oral, 0 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
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2012-09-30
Completion
2012-09-30

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 NCT01515202 on ClinicalTrials.gov