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
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
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on April 16, 2014