Japanese Phase 1 Multiple Ascending Dose Study

NCT ID: NCT01515202

Last Updated: 2012-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2012-09-30

Brief Summary

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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.

Detailed Description

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MAD study - Multiple Ascending Dose study

Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Panel 1: BMS-823778 or Placebo matching BMS-823778

Healthy Subjects

Group Type EXPERIMENTAL

BMS-823778

Intervention Type DRUG

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

Placebo matching with BMS-823778

Intervention Type DRUG

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

Panel 2: BMS-823778 or Placebo matching BMS-823778

Healthy Subjects

Group Type EXPERIMENTAL

BMS-823778

Intervention Type DRUG

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

Placebo matching with BMS-823778

Intervention Type DRUG

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

Panel 3: BMS-823778 or Placebo matching BMS-823778

Healthy Subjects

Group Type EXPERIMENTAL

BMS-823778

Intervention Type DRUG

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

Placebo matching with BMS-823778

Intervention Type DRUG

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

Panel 4: BMS-823778 or Placebo matching BMS-823778

Subjects with T2DM

Group Type EXPERIMENTAL

BMS-823778

Intervention Type DRUG

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

Placebo matching with BMS-823778

Intervention Type DRUG

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

Panel 5: BMS-823778 or Placebo matching BMS-823778

Subjects with T2DM

Group Type EXPERIMENTAL

BMS-823778

Intervention Type DRUG

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

Placebo matching with BMS-823778

Intervention Type DRUG

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

Interventions

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BMS-823778

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

Intervention Type DRUG

BMS-823778

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

Intervention Type DRUG

BMS-823778

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

Intervention Type DRUG

BMS-823778

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

Intervention Type DRUG

Placebo matching with BMS-823778

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Japanese patients with Type 2 Diabetes Mellitus (T2DM) \[Fasting glucose \< 240 mg/dL, Hemoglobin A1c (HbA1c): 6.5% to 10.0% National Glycohemoglobin Standardization Program (NGSP)\] who are treatment-naive and managed with diet and/or exercises only, ages: 20 to 65 years

Exclusion Criteria

* Patient who is taking any medication for T2DM
* Symptoms of poorly controlled diabetes that would preclude participation in this placebo-controlled trial
* Insulin therapy within one year of screening
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Local Institution

Hachioji-Shi, Tokyo, Japan

Site Status

Countries

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Japan

Related Links

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Other Identifiers

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MB121-009

Identifier Type: -

Identifier Source: org_study_id