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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00979368

Enrollment

Registered

2009-09-18

Start date

2009-11-30

Completion date

2010-02-28

Last updated

2011-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Non-Insulin-Dependent, Dyslipidemia

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.

Interventions

DRUGBMS-816336

Suspension, Oral, 15 mg Active, Once on Day 1 only, 4 days

DRUGPlacebo

Suspension, Oral, 0 mg, Once on Day 1 only, 4 days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

MALE

Age

18 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

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

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026