Safety Study to Evaluate BMS-767778 in Healthy Subjects and Subjects With Type 2 Diabetes Mellitus (T2DM) - Full Text View

Sponsored by:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00707590

Purpose

To assess the safety and tolerability and the PK/PD relationship of BMS-767778 administered as single and multiple oral doses in healthy subjects, and in subjects with T2DM

Condition	Intervention	Phase
Type 2 Diabetes Mellitus	Drug: BMS-767778 or Placebo	Phase I

MedlinePlus related topics: Diabetes

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety Study
Official Title:	Randomized, Double-Blind, Placebo-Controlled Ascending Single and Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-767778 in Healthy Subjects and Subjects With Type 2 Diabetes Mellitus

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

AEs, vital signs, ECG and clinical laboratory test results [ Time Frame: throughout the study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Single and multiple dose (14 days) PK [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
DPP-4 inhibition and incretin response [ Time Frame: throughout the study ] [ Designated as safety issue: No ]

Estimated Enrollment:	120
Study Start Date:	August 2008
Estimated Study Completion Date:	April 2009
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Part A: Experimental A: BMS-767778, Oral Solution, Oral, 1 mg, once daily, 1 day OR Placebo Comparator, Oral Solution, Oral, 0 mg, once daily, 1 day B: BMS-767778, Oral Solution, Oral, 3 mg, once daily, 1 day OR Placebo Comparator, Oral Solution, Oral, 0 mg, once daily, 1 day C: BMS-767778, Capsules, Oral, 10 mg, once daily, 1 day OR Placebo Comparator, Capsules, Oral, 0 mg, once daily, 1 day D: BMS-767778, Capsules, Oral, 30 mg, once daily, 1 day OR Placebo Comparator, Capsules, Oral, 0 mg, once daily, 1 day E: BMS-767778, Capsules, Oral, 100 mg, once daily, 1 day OR Placebo Comparator, Capsules, Oral, 0 mg, once daily, 1 day F: BMS-767778, Capsules, Oral, 300 mg, once daily, 2 days OR Placebo Comparator, Capsules, Oral, 0 mg, once daily, 2 days G: BMS-767778, Capsules, Oral, 600 mg, once daily, 1 day OR Placebo Comparator, Capsules, Oral, 0 mg, once daily, 1 day	Drug: BMS-767778 or Placebo
Part B: Experimental A: BMS-767778, Capsules, Oral, 10 mg, once daily, 14 days OR Placebo Comparator, Capsules, Oral, 0 mg, once daily, 14 days B: BMS-767778, Capsules, Oral, 30 mg, once daily, 14 days OR Placebo Comparator, Capsules, Oral, 0 mg, once daily, 14 days C: BMS-767778, Capsules, Oral, 100 mg, once daily, 14 days OR Placebo Comparator, Capsules, Oral, 0 mg, once daily, 14 days D: BMS-767778, Capsules, Oral, 300 mg, once daily, 14 days OR Placebo Comparator, Capsules, Oral, 0 mg, once daily, 14 days E: BMS-767778, Capsules, Oral, 600 mg, once daily, 14 days OR Placebo Comparator, Capsules, Oral, 0 mg, once daily, 14 days	Drug: BMS-767778 or Placebo
Part C: Experimental A: BMS-767778, Capsules, Oral, Adaptive design (between 10 to 600 mg), 14 days OR Placebo Comparator, Capsules, Oral, 0 mg, 14 days B: BMS-767778, Capsules, Oral, Adaptive design (between 10 to 600 mg), 14 days OR Placebo Comparator, Capsules, Oral, 0 mg, 14 days	Drug: BMS-767778 or Placebo

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Parts A and Part B of the study (maximum age 45 years):

Inclusion Criteria:

Healthy male and female subjects as determined by medical history, physical examination, 12-lead electrocardiogram (ECG), and clinical laboratory evaluations will be eligible to participate in the study.
Men and women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile)

Exclusion Criteria:

Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations

Part C of the study (maximum age 65 years):

Inclusion criteria:

Drug naive patients with T2DM or patients who are on metformin-monotherapy (at current dose for ≥ 8 weeks) with inadequately controlled blood glucose levels (HbA1c >7 %and <10 %) Men and women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile)

Exclusion criteria:

Poorly controlled diabetes with either new onset or worsening of symptoms of polyuria and polydipsia, weight loss, fatigue, abdominal pain, or other significant signs and symptoms
Any of the following medical conditions: uncontrolled hypertension, unstable angina pectora, Cushing's syndrome, Addison's disease, uncontrolled hyperthyroidism or hypothyroidism, significant liver disease or renal failure, malignant diseases, or immunodeficiency (e.g., HIV/AIDS or organ-transplant), or history of myocardial infarction, congestive heart failure defined as New York Heart Association (NYHA) stage II and above, significant valvular disease, cardiac arrhythmia, or transient ischemic attack or cerebrovascular accidents (occurred within 6 months prior to entry into the study), or family history of Long QT Syndrome

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00707590

Contacts

Contact: For participation information at a USA site use a phone number below. For site information outside the USA please email:		Clinical.Trials@bms.com
Contact: First line of email MUST contain NCT# & Site#. Only trial sites that are recruiting have contact information at this time.

Locations

Canada
Local Institution	Recruiting
Quebec, Canada, G1P 0A2
Contact: Site 001

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director:

Bristol-Myers Squibb

More Information

BMS Clinical Trials Disclosure 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

Responsible Party:	Bristol-Myers Squibb ( Study Director )
Study ID Numbers:	MB116-001
Study First Received:	June 27, 2008
Last Updated:	January 6, 2009
ClinicalTrials.gov Identifier:	NCT00707590
Health Authority:	Canada: Health Canada

Study placed in the following topic categories:

Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Healthy
Metabolic disorder
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on January 16, 2009