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Safety Study of BMS-816336 in Healthy Male Subjects

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00979368
First Posted: September 18, 2009
Last Update Posted: February 23, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Bristol-Myers Squibb
  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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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

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 ]

Secondary Outcome Measures:
  • To assess the single dose Pharmacokinetics of BMS-816336 [ Time Frame: During 72 hours following dosing ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00979368     History of Changes
Other Study ID Numbers: MB124-001
First Submitted: September 17, 2009
First Posted: September 18, 2009
Last Update Posted: February 23, 2011
Last Verified: October 2009

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