NCT01515202
Completed
Phase 1
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
ConditionsType 2 Diabetes Mellitus
Overview
- Phase
- Phase 1
- Intervention
- BMS-823778
- Conditions
- Type 2 Diabetes Mellitus
- Sponsor
- Bristol-Myers Squibb
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Safety and tolerability, as measured by the number, frequency and intensity of adverse events, vital sign measurements, ECGs, physical examinations, and clinical laboratory tests
- Status
- Completed
- Last Updated
- 13 years ago
Overview
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
Investigators
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
Arms & Interventions
Panel 4: BMS-823778 or Placebo matching BMS-823778
Subjects with T2DM
Intervention: BMS-823778
Panel 1: BMS-823778 or Placebo matching BMS-823778
Healthy Subjects
Intervention: BMS-823778
Panel 1: BMS-823778 or Placebo matching BMS-823778
Healthy Subjects
Intervention: Placebo matching with BMS-823778
Panel 2: BMS-823778 or Placebo matching BMS-823778
Healthy Subjects
Intervention: BMS-823778
Panel 2: BMS-823778 or Placebo matching BMS-823778
Healthy Subjects
Intervention: Placebo matching with BMS-823778
Panel 3: BMS-823778 or Placebo matching BMS-823778
Healthy Subjects
Intervention: BMS-823778
Panel 3: BMS-823778 or Placebo matching BMS-823778
Healthy Subjects
Intervention: Placebo matching with BMS-823778
Panel 4: BMS-823778 or Placebo matching BMS-823778
Subjects with T2DM
Intervention: Placebo matching with BMS-823778
Panel 5: BMS-823778 or Placebo matching BMS-823778
Subjects with T2DM
Intervention: BMS-823778
Panel 5: BMS-823778 or Placebo matching BMS-823778
Subjects with T2DM
Intervention: Placebo matching with BMS-823778
Outcomes
Primary Outcomes
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 Outcomes
- 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)
Study Sites (1)
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