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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes Mellitus
 Drug: BMS-823778
Drug: Placebo matching with BMS-823778
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

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 [ Time Frame: Up to Day 21 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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


Enrollment: 40
Study Start Date: March 2012
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Panel 1: BMS-823778 or Placebo matching BMS-823778
Healthy Subjects
 Drug: BMS-823778
Capsules, Oral, 2 mg, Once daily, 14 days
Drug: Placebo matching with BMS-823778
Capsules, Oral, 0 mg, Once daily, 14 days
Experimental: Panel 2: BMS-823778 or Placebo matching BMS-823778
Healthy Subjects
 Drug: BMS-823778
Capsules, Oral, 12 mg, Once daily, 14 days
Drug: Placebo matching with BMS-823778
Capsules, Oral, 0 mg, Once daily, 14 days
Experimental: Panel 3: BMS-823778 or Placebo matching BMS-823778
Healthy Subjects
 Drug: BMS-823778
Capsules, Oral, 25 mg, Once daily, 14 days
Drug: Placebo matching with BMS-823778
Capsules, Oral, 0 mg, Once daily, 14 days
Experimental: Panel 4: BMS-823778 or Placebo matching BMS-823778
Subjects with T2DM
 Drug: BMS-823778
Capsules, Oral, 2 mg, Once daily, 14 days
Drug: Placebo matching with BMS-823778
Capsules, Oral, 0 mg, Once daily, 14 days
Experimental: Panel 5: BMS-823778 or Placebo matching BMS-823778
Subjects with T2DM
 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

Detailed Description:

MAD study - Multiple Ascending Dose study

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01515202

Locations
Japan
Local Institution
Hachioji-Shi, Tokyo, Japan, 1920071
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
BMS Clinical Trials Disclosure  This link exits the ClinicalTrials.gov site
Investigator Inquiry form  This link exits the ClinicalTrials.gov site
For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01515202     History of Changes
Other Study ID Numbers: MB121-009
Study First Received: January 18, 2012
Last Updated: December 4, 2012
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 16, 2013