Safety Study of BMS-816336 in Healthy Male Subjects

Dyslipidemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00979368
• Other study ID #: MB124-001
• Status: Completed
• Phase: Phase 1
• First received: September 17, 2009
• Last updated: February 22, 2011
• Start date: November 2009
• Est. completion date: February 2010

Study information

• Verified date: October 2009
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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-ß-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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Diabetes Mellitus, Non-Insulin-Dependent
• Diabetes Mellitus, Type 2
• Dyslipidemia
• Dyslipidemias

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Australia	Local Institution	Melbourne	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Exposure to the investigational drug will be measured to assess safety and tolerability		Within 72 hours following dosing	Yes
Secondary	To assess the single dose Pharmacokinetics of BMS-816336		During 72 hours following dosing	No

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm
•   Investigator Inquiry form