Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
40 participants
INTERVENTIONAL
2009-11-30
2010-02-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Single Ascending Dose Safety Study of BMS-962476 in Healthy Subjects and Patients With Elevated Cholesterol on Statins
NCT01587365
A Randomized, Double Blind Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986166 in Healthy Subjects
NCT02790125
A Study to Evaluate the Safety, Tolerability and Drug Levels of BMS-986447 in Healthy Participants
NCT05760937
A Single-dose Study to Evaluate the Safety, Tolerability, Drug Levels, and Relative Biological Availability of Alternate Formulations of BMS-986460 in Healthy Adult Male Participants
NCT06877702
A Study of Pharmacokinetics (PK) and Pharmacodynamics (PD) in Relation to Prednisolone in Healthy Males
NCT03198013
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
BMS-816336 or placebo (Panel 1)
BMS-816336
Suspension, Oral, 15 mg Active, Once on Day 1 only, 4 days
Placebo
Suspension, Oral, 0 mg, Once on Day 1 only, 4 days
BMS-816336 or placebo (Panel 2)
BMS-816336
Suspension, Oral, 60 mg Active, Once on Day 1 only, 4 days
Placebo
Suspension, Oral, 0 mg, Once on Day 1 only, 4 days
BMS-816336 or placebo (Panel 3)
BMS-816336
Suspension, Oral, 180 mg Active, Once on Day 1 only, 4 days
Placebo
Suspension, Oral, 0 mg, Once on Day 1 only, 4 days
BMS-816336 or placebo (Panel 4)
BMS-816336
Suspension, Oral, 450 mg Active, Once on Day 1 only, 4 days
Placebo
Suspension, Oral, 0 mg, Once on Day 1 only, 4 days
BMS-816336 or placebo (Panel 5)
BMS-816336
Suspension, Oral, 900 mg Active, Once on Day 1 only, 4 days
Placebo
Suspension, Oral, 0 mg, Once on Day 1 only, 4 days
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
BMS-816336
Suspension, Oral, 15 mg Active, Once on Day 1 only, 4 days
BMS-816336
Suspension, Oral, 60 mg Active, Once on Day 1 only, 4 days
BMS-816336
Suspension, Oral, 180 mg Active, Once on Day 1 only, 4 days
BMS-816336
Suspension, Oral, 450 mg Active, Once on Day 1 only, 4 days
BMS-816336
Suspension, Oral, 900 mg Active, Once on Day 1 only, 4 days
Placebo
Suspension, Oral, 0 mg, Once on Day 1 only, 4 days
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* BMI of 18 to 32 kg/m²
* Men only, ages 18-55 years
Exclusion Criteria
* 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
18 Years
55 Years
MALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Bristol-Myers Squibb
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Bristol-Myers Squibb
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Local Institution
Melbourne, Victoria, Australia
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
Investigator Inquiry form
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
MB124-001
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.