Japanese Phase 1 Multiple Ascending Dose Study

Phase 1

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: BMS-823778; Drug: Placebo matching with BMS-823778

• Registration Number: NCT01515202
• Lead Sponsor: Bristol-Myers Squibb

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

Study Timeline

• Study First Submitted: 2012-01-18
• Study First Submitted QC: 2012-01-23
• Study First Posted: 2012-01-24
• Study Start: 2012-03
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Status Verified: 2012-12
• Last Update Submitted: 2012-12-04
• Last Update Posted: 2012-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Panel 1: BMS-823778 or Placebo matching BMS-823778	BMS-823778	Healthy Subjects
Panel 5: BMS-823778 or Placebo matching BMS-823778	BMS-823778	Subjects with T2DM
Panel 1: BMS-823778 or Placebo matching BMS-823778	Placebo matching with BMS-823778	Healthy Subjects
Panel 2: BMS-823778 or Placebo matching BMS-823778	BMS-823778	Healthy Subjects
Panel 2: BMS-823778 or Placebo matching BMS-823778	Placebo matching with BMS-823778	Healthy Subjects
Panel 3: BMS-823778 or Placebo matching BMS-823778	BMS-823778	Healthy Subjects
Panel 3: BMS-823778 or Placebo matching BMS-823778	Placebo matching with BMS-823778	Healthy Subjects
Panel 4: BMS-823778 or Placebo matching BMS-823778	BMS-823778	Subjects with T2DM
Panel 4: BMS-823778 or Placebo matching BMS-823778	Placebo matching with BMS-823778	Subjects with T2DM
Panel 5: BMS-823778 or Placebo matching BMS-823778	Placebo matching with BMS-823778	Subjects with T2DM

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Plasma half-life (T-HALF) of BMS-823778, as measured by plasma/urine concentration	Up to Day 21
Percent urinary recovery (% UR) of BMS-823778, as measured by plasma/urine concentration	Up to Day 21
Apparent total body clearance (CLT/F) of BMS-823778, as measured by plasma/urine concentration	Up to Day 21
Renal clearance from plasma (CLR) of BMS-823778, as measured by plasma/urine concentration	Up to Day 21
Peak to trough ratio (Cmax/Cmin) of BMS-823778, as measured by plasma/urine concentration	Up to Day 21
Effective plasma half-life (T-HALFeff) of BMS-823778, as measured by plasma/urine concentration	Up to Day 21
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)	Up to Day 21	* HPA = Hypothalamic-pituitary-adrenal; * DHEA-S = Dehydroepiandrosterone-sulphate; * ACTH = adrenocorticotropic hormone

Trial Locations

Locations (1)

Local Institution; 🇯🇵 Hachioji-Shi, Tokyo, Japan