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Japanese Phase 1 Multiple Ascending Dose Study

Primary Purpose

Type 2 Diabetes Mellitus

Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
BMS-823778
BMS-823778
BMS-823778
BMS-823778
Placebo matching with BMS-823778
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Local Institution

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

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

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

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

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

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

Arm Description

Healthy Subjects

Healthy Subjects

Healthy Subjects

Subjects with T2DM

Subjects with T2DM

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Maximum observed plasma concentration (Cmax) of BMS-823778, as measured by plasma/urine concentration
Trough observed plasma concentration (Cmin) of BMS-823778, as measured by plasma/urine concentration
Time of maximum observed plasma concentration (Tmax) of BMS-823778, as measured by plasma/urine concentration
Area under the plasma concentration-time curve in one dosing interval [AUC(TAU)] of BMS-823778, as measured by plasma/urine concentration
Accumulation Index following multiple dosing (AI) of BMS-823778, as measured by plasma/urine concentration
Plasma half-life (T-HALF) of BMS-823778, as measured by plasma/urine concentration
Percent urinary recovery (% UR) of BMS-823778, as measured by plasma/urine concentration
Apparent total body clearance (CLT/F) of BMS-823778, as measured by plasma/urine concentration
Renal clearance from plasma (CLR) of BMS-823778, as measured by plasma/urine concentration
Peak to trough ratio (Cmax/Cmin) of BMS-823778, as measured by plasma/urine concentration
Effective plasma half-life (T-HALFeff) of BMS-823778, as measured by plasma/urine concentration
Pharmacodynamics, as measured by Serum concentration of cortisol and cortisone after an oral dose of cortisone and biomarkers for HPA axis activity (urinary free cortisol and cortisone, salivary cortisol, ACTH, DHEA-S and 4-androstenedione)
HPA = Hypothalamic-pituitary-adrenal DHEA-S = Dehydroepiandrosterone-sulphate ACTH = adrenocorticotropic hormone

Full Information

First Posted
January 18, 2012
Last Updated
December 4, 2012
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT01515202
Brief Title
Japanese Phase 1 Multiple Ascending Dose Study
Official Title
A Randomized, Placebo-Controlled, Double-Blinded, Multiple Dose Escalation Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of BMS-823778 in Healthy Subjects and Patients With Type 2 Diabetes Mellitus
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
MAD study - Multiple Ascending Dose study

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Panel 1: BMS-823778 or Placebo matching BMS-823778
Arm Type
Experimental
Arm Description
Healthy Subjects
Arm Title
Panel 2: BMS-823778 or Placebo matching BMS-823778
Arm Type
Experimental
Arm Description
Healthy Subjects
Arm Title
Panel 3: BMS-823778 or Placebo matching BMS-823778
Arm Type
Experimental
Arm Description
Healthy Subjects
Arm Title
Panel 4: BMS-823778 or Placebo matching BMS-823778
Arm Type
Experimental
Arm Description
Subjects with T2DM
Arm Title
Panel 5: BMS-823778 or Placebo matching BMS-823778
Arm Type
Experimental
Arm Description
Subjects with T2DM
Intervention Type
Drug
Intervention Name(s)
BMS-823778
Intervention Description
Capsules, Oral, 2 mg, Once daily, 14 days
Intervention Type
Drug
Intervention Name(s)
BMS-823778
Intervention Description
Capsules, Oral, 12 mg, Once daily, 14 days
Intervention Type
Drug
Intervention Name(s)
BMS-823778
Intervention Description
Capsules, Oral, 25 mg, Once daily, 14 days
Intervention Type
Drug
Intervention Name(s)
BMS-823778
Intervention Description
Capsules, Oral, 15 mg, Once daily, 14 days
Intervention Type
Drug
Intervention Name(s)
Placebo matching with BMS-823778
Intervention Description
Capsules, Oral, 0 mg, Once daily, 14 days
Primary Outcome Measure Information:
Title
Safety and tolerability, as measured by the number, frequency and intensity of adverse events, vital sign measurements, ECGs, physical examinations, and clinical laboratory tests
Time Frame
Up to Day 21
Secondary Outcome Measure Information:
Title
Maximum observed plasma concentration (Cmax) of BMS-823778, as measured by plasma/urine concentration
Time Frame
Up to Day 21
Title
Trough observed plasma concentration (Cmin) of BMS-823778, as measured by plasma/urine concentration
Time Frame
Up to Day 21
Title
Time of maximum observed plasma concentration (Tmax) of BMS-823778, as measured by plasma/urine concentration
Time Frame
Up to Day 21
Title
Area under the plasma concentration-time curve in one dosing interval [AUC(TAU)] of BMS-823778, as measured by plasma/urine concentration
Time Frame
Up to Day 21
Title
Accumulation Index following multiple dosing (AI) of BMS-823778, as measured by plasma/urine concentration
Time Frame
Up to Day 21
Title
Plasma half-life (T-HALF) of BMS-823778, as measured by plasma/urine concentration
Time Frame
Up to Day 21
Title
Percent urinary recovery (% UR) of BMS-823778, as measured by plasma/urine concentration
Time Frame
Up to Day 21
Title
Apparent total body clearance (CLT/F) of BMS-823778, as measured by plasma/urine concentration
Time Frame
Up to Day 21
Title
Renal clearance from plasma (CLR) of BMS-823778, as measured by plasma/urine concentration
Time Frame
Up to Day 21
Title
Peak to trough ratio (Cmax/Cmin) of BMS-823778, as measured by plasma/urine concentration
Time Frame
Up to Day 21
Title
Effective plasma half-life (T-HALFeff) of BMS-823778, as measured by plasma/urine concentration
Time Frame
Up to Day 21
Title
Pharmacodynamics, as measured by Serum concentration of cortisol and cortisone after an oral dose of cortisone and biomarkers for HPA axis activity (urinary free cortisol and cortisone, salivary cortisol, ACTH, DHEA-S and 4-androstenedione)
Description
HPA = Hypothalamic-pituitary-adrenal DHEA-S = Dehydroepiandrosterone-sulphate ACTH = adrenocorticotropic hormone
Time Frame
Up to Day 21

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Local Institution
City
Hachioji-Shi
State/Province
Tokyo
ZIP/Postal Code
1920071
Country
Japan

12. IPD Sharing Statement

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Japanese Phase 1 Multiple Ascending Dose Study

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