Japanese Phase 1 Multiple Ascending Dose Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01515202
First received: January 18, 2012
Last updated: December 4, 2012
Last verified: December 2012

January 18, 2012
December 4, 2012
March 2012
September 2012   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01515202 on ClinicalTrials.gov Archive Site
  • Maximum observed plasma concentration (Cmax) of BMS-823778, as measured by plasma/urine concentration [ Time Frame: Up to Day 21 ] [ Designated as safety issue: No ]
  • Trough observed plasma concentration (Cmin) of BMS-823778, as measured by plasma/urine concentration [ Time Frame: Up to Day 21 ] [ Designated as safety issue: No ]
  • Time of maximum observed plasma concentration (Tmax) of BMS-823778, as measured by plasma/urine concentration [ Time Frame: Up to Day 21 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Accumulation Index following multiple dosing (AI) of BMS-823778, as measured by plasma/urine concentration [ Time Frame: Up to Day 21 ] [ Designated as safety issue: No ]
  • Plasma half-life (T-HALF) of BMS-823778, as measured by plasma/urine concentration [ Time Frame: Up to Day 21 ] [ Designated as safety issue: No ]
  • Percent urinary recovery (% UR) of BMS-823778, as measured by plasma/urine concentration [ Time Frame: Up to Day 21 ] [ Designated as safety issue: No ]
  • Apparent total body clearance (CLT/F) of BMS-823778, as measured by plasma/urine concentration [ Time Frame: Up to Day 21 ] [ Designated as safety issue: No ]
  • Renal clearance from plasma (CLR) of BMS-823778, as measured by plasma/urine concentration [ Time Frame: Up to Day 21 ] [ Designated as safety issue: No ]
  • Peak to trough ratio (Cmax/Cmin) of BMS-823778, as measured by plasma/urine concentration [ Time Frame: Up to Day 21 ] [ Designated as safety issue: No ]
  • Effective plasma half-life (T-HALFeff) of BMS-823778, as measured by plasma/urine concentration [ Time Frame: Up to Day 21 ] [ Designated as safety issue: No ]
  • 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) [ Time Frame: Up to Day 21 ] [ Designated as safety issue: Yes ]
    • HPA = Hypothalamic-pituitary-adrenal
    • DHEA-S = Dehydroepiandrosterone-sulphate
    • ACTH = adrenocorticotropic hormone
Same as current
Not Provided
Not Provided
 
Japanese Phase 1 Multiple Ascending Dose Study
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

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.

MAD study - Multiple Ascending Dose study

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
  • Drug: BMS-823778
    Capsules, Oral, 2 mg, Once daily, 14 days
  • Drug: BMS-823778
    Capsules, Oral, 12 mg, Once daily, 14 days
  • Drug: BMS-823778
    Capsules, Oral, 25 mg, Once daily, 14 days
  • Drug: BMS-823778
    Capsules, Oral, 15 mg, Once daily, 14 days
  • Drug: Placebo matching with BMS-823778
    Capsules, Oral, 0 mg, Once daily, 14 days
  • Experimental: Panel 1: BMS-823778 or Placebo matching BMS-823778
    Healthy Subjects
    Interventions:
    • Drug: BMS-823778
    • Drug: Placebo matching with BMS-823778
  • Experimental: Panel 2: BMS-823778 or Placebo matching BMS-823778
    Healthy Subjects
    Interventions:
    • Drug: BMS-823778
    • Drug: Placebo matching with BMS-823778
  • Experimental: Panel 3: BMS-823778 or Placebo matching BMS-823778
    Healthy Subjects
    Interventions:
    • Drug: BMS-823778
    • Drug: Placebo matching with BMS-823778
  • Experimental: Panel 4: BMS-823778 or Placebo matching BMS-823778
    Subjects with T2DM
    Interventions:
    • Drug: BMS-823778
    • Drug: Placebo matching with BMS-823778
  • Experimental: Panel 5: BMS-823778 or Placebo matching BMS-823778
    Subjects with T2DM
    Interventions:
    • Drug: BMS-823778
    • Drug: Placebo matching with BMS-823778
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
September 2012
September 2012   (final data collection date for primary outcome measure)

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
Both
20 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01515202
MB121-009
No
Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP