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
1 other identifier
interventional
40
1 country
1
Brief Summary
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics following single oral doses of BMS-816336 in healthy male subjects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Nov 2009
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 17, 2009
CompletedFirst Posted
Study publicly available on registry
September 18, 2009
CompletedStudy Start
First participant enrolled
November 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2010
CompletedFebruary 23, 2011
October 1, 2009
3 months
September 17, 2009
February 22, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
Exposure to the investigational drug will be measured to assess safety and tolerability
Within 72 hours following dosing
Secondary Outcomes (1)
To assess the single dose Pharmacokinetics of BMS-816336
During 72 hours following dosing
Study Arms (5)
BMS-816336 or placebo (Panel 1)
ACTIVE COMPARATORBMS-816336 or placebo (Panel 2)
ACTIVE COMPARATORBMS-816336 or placebo (Panel 3)
ACTIVE COMPARATORBMS-816336 or placebo (Panel 4)
ACTIVE COMPARATORBMS-816336 or placebo (Panel 5)
ACTIVE COMPARATORInterventions
Suspension, Oral, 15 mg Active, Once on Day 1 only, 4 days
Suspension, Oral, 0 mg, Once on Day 1 only, 4 days
Eligibility Criteria
You may qualify if:
- Healthy male subjects
- BMI of 18 to 32 kg/m²
- Men only, ages 18-55 years
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Local Institution
Melbourne, Victoria, 3004, Australia
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 17, 2009
First Posted
September 18, 2009
Study Start
November 1, 2009
Primary Completion
February 1, 2010
Study Completion
February 1, 2010
Last Updated
February 23, 2011
Record last verified: 2009-10