NCT01515202

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1 type-2-diabetes-mellitus

Timeline
Completed

Started Mar 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 18, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 24, 2012

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

December 5, 2012

Status Verified

December 1, 2012

Enrollment Period

6 months

First QC Date

January 18, 2012

Last Update Submit

December 4, 2012

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • Safety and tolerability, as measured by the number, frequency and intensity of adverse events, vital sign measurements, ECGs, physical examinations, and clinical laboratory tests

    Up to Day 21

Secondary Outcomes (12)

  • Maximum observed plasma concentration (Cmax) of BMS-823778, as measured by plasma/urine concentration

    Up to Day 21

  • Trough observed plasma concentration (Cmin) of BMS-823778, as measured by plasma/urine concentration

    Up to Day 21

  • Time of maximum observed plasma concentration (Tmax) of BMS-823778, as measured by plasma/urine concentration

    Up to Day 21

  • Area under the plasma concentration-time curve in one dosing interval [AUC(TAU)] of BMS-823778, as measured by plasma/urine concentration

    Up to Day 21

  • Accumulation Index following multiple dosing (AI) of BMS-823778, as measured by plasma/urine concentration

    Up to Day 21

  • +7 more secondary outcomes

Study Arms (5)

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

EXPERIMENTAL

Healthy Subjects

Drug: BMS-823778Drug: Placebo matching with BMS-823778

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

EXPERIMENTAL

Healthy Subjects

Drug: BMS-823778Drug: Placebo matching with BMS-823778

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

EXPERIMENTAL

Healthy Subjects

Drug: BMS-823778Drug: Placebo matching with BMS-823778

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

EXPERIMENTAL

Subjects with T2DM

Drug: BMS-823778Drug: Placebo matching with BMS-823778

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

EXPERIMENTAL

Subjects with T2DM

Drug: BMS-823778Drug: Placebo matching with BMS-823778

Interventions

BMS-823778DRUG

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

Panel 1: BMS-823778 or Placebo matching BMS-823778Panel 4: BMS-823778 or Placebo matching BMS-823778
Placebo matching with BMS-823778DRUG

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

Panel 1: BMS-823778 or Placebo matching BMS-823778Panel 2: BMS-823778 or Placebo matching BMS-823778Panel 3: BMS-823778 or Placebo matching BMS-823778Panel 4: BMS-823778 or Placebo matching BMS-823778Panel 5: BMS-823778 or Placebo matching BMS-823778

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Local Institution

Hachioji-Shi, Tokyo, 1920071, Japan

Location

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

BMS-823778

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 18, 2012

First Posted

January 24, 2012

Study Start

March 1, 2012

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

December 5, 2012

Record last verified: 2012-12

Locations

JP(1)