NCT01240980

Brief Summary

The purpose of this study is to evaluate the safety, tolerability and effect on blood glucose control of BMS-903452 compared to placebo in healthy subjects \& relative bioavailability of the crystalline and amorphous forms of BMS-903452 \[Panels 4,6,11 \& 12(Part A)\] ; and subjects with type 2 Diabetes Mellitus (Part B). The study will also determine the amount of BMS-903452 in the blood.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
104

participants targeted

Target at P75+ for phase_1 diabetes

Timeline
Completed

Started Nov 2010

Longer than P75 for phase_1 diabetes

Geographic Reach
1 country

2 active sites

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

Study Start

First participant enrolled

November 1, 2010

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

November 11, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 15, 2010

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

March 15, 2012

Status Verified

November 1, 2011

Enrollment Period

1.2 years

First QC Date

November 11, 2010

Last Update Submit

March 14, 2012

Conditions

Diabetes

Outcome Measures

Primary Outcomes (1)

  • Safety and Tolerability of the investigational drug, as assessed by adverse event monitoring, physical examinations, clinical laboratory determinations, electrocardiograms (ECG), and vital sign assessments

    Within 10 days of study drug administration

Secondary Outcomes (10)

  • Pharmacodynamic activity of the investigational drug on glucose and hormones regulating glucose metabolism

    Within 2 days of study drug administration

  • Effect on electrocardiographic (ECG) parameters

    Within 10 days of study drug administration

  • Percent urinary recovery (% UR)

    Within 10 days of study drug administration

  • Renal clearance (CLR) from plasma

    Within 10 days of study drug administration

  • The single-dose pharmacokinetics parameter maximum observed concentration in plasma (Cmax) of BMS-903452 will be derived from the plasma concentration versus time data

    Within 10 days after study drug administration

  • +5 more secondary outcomes

Study Arms (12)

BMS-903452 (0.1 mg) or Placebo - A1

EXPERIMENTAL

(Healthy Subjects)

Drug: BMS-903452Drug: Placebo

BMS-903452 (0.6 mg) or Placebo - A2

EXPERIMENTAL

(Healthy Subjects)

Drug: BMS-903452Drug: Placebo

BMS-903452 (3.0 mg) or Placebo - A3

EXPERIMENTAL

(Healthy Subjects)

Drug: BMS-903452Drug: Placebo

BMS-903452 (10 mg) or Placebo - A4

EXPERIMENTAL

(Healthy Subjects)

Drug: BMS-903452Drug: Placebo

BMS-903452 (30 mg) or Placebo - A5

EXPERIMENTAL

(Healthy Subjects)

Drug: BMS-903452Drug: Placebo

BMS-903452 (60 mg) or Placebo - A6

EXPERIMENTAL

(Healthy Subjects)

Drug: BMS-903452Drug: Placebo

BMS-903452 (120 mg) or Placebo - A7

EXPERIMENTAL

(Healthy Subjects)

Drug: BMS-903452Drug: Placebo

BMS-903452 (0.6 mg) or Placebo - B1

EXPERIMENTAL

(Subjects with type 2 Diabetes Mellitus)

Drug: PlaceboDrug: BMS-903452

BMS-903452 (10 mg) or Placebo - B2

EXPERIMENTAL

(Subjects with type 2 Diabetes Mellitus)

Drug: PlaceboDrug: BMS-903452

BMS-903452 (120 mg) or Placebo - B3

EXPERIMENTAL

(Subjects with type 2 Diabetes Mellitus)

Drug: PlaceboDrug: BMS-903452

BMS-903452 (10 mg) or Placebo - A11

EXPERIMENTAL

(Healthy Subjects)

Drug: BMS-903452Drug: Placebo

BMS-903452 (60 mg) or Placebo - A12

EXPERIMENTAL

(Healthy Subjects)

Drug: BMS-903452Drug: Placebo

Interventions

BMS-903452DRUG

Solution, Oral, 0.1 mg, once daily, 1 day

BMS-903452 (0.1 mg) or Placebo - A1
PlaceboDRUG

Solution, Oral, 0 mg, once daily, 1 day

BMS-903452 (0.1 mg) or Placebo - A1BMS-903452 (0.6 mg) or Placebo - A2BMS-903452 (0.6 mg) or Placebo - B1

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinically healthy or Clinical diagnosis of Type 2 diabetes on a stable dose of metformin monotherapy

You may not qualify if:

  • Type 1 Diabetes
  • History of significant heart disease
  • Prior bariatric surgery
  • Women of childbearing potential

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Comprehensive Phase One

Miramar, Florida, 33025, United States

Location

Ppd Development, Lp

Austin, Texas, 78744, United States

Location

Related Links

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

5-chloro-4-((1-(5-chloropyrimidin-2-yl)piperidin-4-yl)oxy)-1-(2-fluoro-4-(methylsulfonyl)phenyl)pyridin-2(1H)-one

Condition Hierarchy (Ancestors)

Glucose 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
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 11, 2010

First Posted

November 15, 2010

Study Start

November 1, 2010

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

March 15, 2012

Record last verified: 2011-11

Locations

US(2)