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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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 August 28, 2014