Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Safety Study of BMS-816336 in Healthy Male Subjects

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00979368
First received: September 17, 2009
Last updated: February 22, 2011
Last verified: October 2009
  Purpose

The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics following single oral doses of BMS-816336 in healthy male subjects.


Condition Intervention Phase
Diabetes Mellitus, Non-Insulin-Dependent
Dyslipidemia
Drug: BMS-816336
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Official Title: Randomized, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BMS-816336 in Healthy Male Subjects

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Exposure to the investigational drug will be measured to assess safety and tolerability [ Time Frame: Within 72 hours following dosing ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To assess the single dose Pharmacokinetics of BMS-816336 [ Time Frame: During 72 hours following dosing ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: November 2009
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: BMS-816336 or placebo (Panel 1) Drug: BMS-816336
Suspension, Oral, 15 mg Active, Once on Day 1 only, 4 days
Drug: Placebo
Suspension, Oral, 0 mg, Once on Day 1 only, 4 days
Active Comparator: BMS-816336 or placebo (Panel 2) Drug: BMS-816336
Suspension, Oral, 60 mg Active, Once on Day 1 only, 4 days
Drug: Placebo
Suspension, Oral, 0 mg, Once on Day 1 only, 4 days
Active Comparator: BMS-816336 or placebo (Panel 3) Drug: BMS-816336
Suspension, Oral, 180 mg Active, Once on Day 1 only, 4 days
Drug: Placebo
Suspension, Oral, 0 mg, Once on Day 1 only, 4 days
Active Comparator: BMS-816336 or placebo (Panel 4) Drug: BMS-816336
Suspension, Oral, 450 mg Active, Once on Day 1 only, 4 days
Drug: Placebo
Suspension, Oral, 0 mg, Once on Day 1 only, 4 days
Active Comparator: BMS-816336 or placebo (Panel 5) Drug: BMS-816336
Suspension, Oral, 900 mg Active, Once on Day 1 only, 4 days
Drug: Placebo
Suspension, Oral, 0 mg, Once on Day 1 only, 4 days

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male subjects
  • BMI of 18 to 32 kg/m²
  • Men only, ages 18-55 years

Exclusion Criteria:

  • Sexually active men not using effective birth control if their partners are WOCBP
  • Any significant acute or chronic medical illness
  • Family history of Gilbert's disease
  • History of Pancreatitis
  • Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, EGG or clinical laboratory determinations
  • QTc interval > 450 msec (corrected for heart rate using Fridericia's correction method, QTcF)
  • Second- or third-degree A-V block or clinically relevant ECG abnormalities
  • History of allergy to 11-β-HSD-1 inhibitors or related compounds
  • Prior exposure to BMS-816336
  • Use of St. John's Wort (Hypericum) within 4 weeks prior to the first dose of study drug and throughout the study
  • Use of an oral, injectable, inhalable or suspension of glucocorticoid agents within 12 weeks of study drug administration
  • Use of any glucocorticoid topical creams within 4 weeks of study drug administration
  • Use of oral, injectable, or topical androgen agent within 12 weeks prior to enrollment
  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: NCT00979368

Locations
Australia, Victoria
Local Institution
Melbourne, Victoria, Australia, 3004
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00979368     History of Changes
Other Study ID Numbers: MB124-001
Study First Received: September 17, 2009
Last Updated: February 22, 2011
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

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

ClinicalTrials.gov processed this record on November 27, 2014