Safety Study of BMS-816336 in Healthy Male Subjects

Randomized, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BMS-816336 in Healthy Male Subjects

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

Study Overview

• Status: Completed
• Conditions: Dyslipidemia; Diabetes Mellitus, Non-Insulin-Dependent
• Intervention / Treatment: Drug: BMS-816336; Drug: BMS-816336; Drug: BMS-816336; Drug: BMS-816336; Drug: BMS-816336; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 1

Contacts and Locations

Study Locations

• Australia
  • Victoria
    • Melbourne, Victoria, Australia, 3004
      • Local Institution

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: BMS-816336 or placebo (Panel 1)	Drug: BMS-816336; Suspension, Oral, 15 mg Active, Once on Day 1 only, 4 days; Drug: BMS-816336; Suspension, Oral, 60 mg Active, Once on Day 1 only, 4 days; Drug: BMS-816336; Suspension, Oral, 180 mg Active, Once on Day 1 only, 4 days; Drug: BMS-816336; Suspension, Oral, 450 mg Active, Once on Day 1 only, 4 days; 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
Active Comparator: BMS-816336 or placebo (Panel 2)	Drug: BMS-816336; Suspension, Oral, 15 mg Active, Once on Day 1 only, 4 days; Drug: BMS-816336; Suspension, Oral, 60 mg Active, Once on Day 1 only, 4 days; Drug: BMS-816336; Suspension, Oral, 180 mg Active, Once on Day 1 only, 4 days; Drug: BMS-816336; Suspension, Oral, 450 mg Active, Once on Day 1 only, 4 days; 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
Active Comparator: BMS-816336 or placebo (Panel 3)	Drug: BMS-816336; Suspension, Oral, 15 mg Active, Once on Day 1 only, 4 days; Drug: BMS-816336; Suspension, Oral, 60 mg Active, Once on Day 1 only, 4 days; Drug: BMS-816336; Suspension, Oral, 180 mg Active, Once on Day 1 only, 4 days; Drug: BMS-816336; Suspension, Oral, 450 mg Active, Once on Day 1 only, 4 days; 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
Active Comparator: BMS-816336 or placebo (Panel 4)	Drug: BMS-816336; Suspension, Oral, 15 mg Active, Once on Day 1 only, 4 days; Drug: BMS-816336; Suspension, Oral, 60 mg Active, Once on Day 1 only, 4 days; Drug: BMS-816336; Suspension, Oral, 180 mg Active, Once on Day 1 only, 4 days; Drug: BMS-816336; Suspension, Oral, 450 mg Active, Once on Day 1 only, 4 days; 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
Active Comparator: BMS-816336 or placebo (Panel 5)	Drug: BMS-816336; Suspension, Oral, 15 mg Active, Once on Day 1 only, 4 days; Drug: BMS-816336; Suspension, Oral, 60 mg Active, Once on Day 1 only, 4 days; Drug: BMS-816336; Suspension, Oral, 180 mg Active, Once on Day 1 only, 4 days; Drug: BMS-816336; Suspension, Oral, 450 mg Active, Once on Day 1 only, 4 days; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Exposure to the investigational drug will be measured to assess safety and tolerability	Within 72 hours following dosing

Secondary Outcome Measures

Outcome Measure	Time Frame
To assess the single dose Pharmacokinetics of BMS-816336	During 72 hours following dosing

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Study record dates

Study Major Dates

• Study Start: November 1, 2009
• Primary Completion (Actual): February 1, 2010
• Study Completion (Actual): February 1, 2010

Study Registration Dates

• First Submitted: September 17, 2009
• First Submitted That Met QC Criteria: September 17, 2009
• First Posted (Estimate): September 18, 2009

Study Record Updates

• Last Update Posted (Estimate): February 23, 2011
• Last Update Submitted That Met QC Criteria: February 22, 2011
• Last Verified: October 1, 2009

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Lipid Metabolism Disorders; Diabetes Mellitus, Type 2; Dyslipidemias
• Other Study ID Numbers: MB124-001