Safety Study of BMS-816336 in Healthy Male Subjects

Phase 1

Completed

• Conditions: Dyslipidemia; Diabetes Mellitus, Non-Insulin-Dependent
• Interventions: Drug: BMS-816336; Drug: Placebo

• Registration Number: NCT00979368
• Lead Sponsor: Bristol-Myers Squibb

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2009-09-17
• Study First Submitted QC: 2009-09-17
• Study First Posted: 2009-09-18
• Status Verified: 2009-10
• Study Start: 2009-11
• Primary Completion: 2010-02
• Study Completion: 2010-02
• Last Update Submitted: 2011-02-22
• Last Update Posted: 2011-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 40

Inclusion Criteria

• Healthy male subjects
• BMI of 18 to 32 kg/m²
• Men only, ages 18-55 years

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BMS-816336 or placebo (Panel 1)	Placebo	-
BMS-816336 or placebo (Panel 2)	BMS-816336	-
BMS-816336 or placebo (Panel 1)	BMS-816336	-
BMS-816336 or placebo (Panel 3)	Placebo	-
BMS-816336 or placebo (Panel 4)	Placebo	-
BMS-816336 or placebo (Panel 2)	Placebo	-
BMS-816336 or placebo (Panel 4)	BMS-816336	-
BMS-816336 or placebo (Panel 3)	BMS-816336	-
BMS-816336 or placebo (Panel 5)	Placebo	-
BMS-816336 or placebo (Panel 5)	BMS-816336	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Local Institution; 🇦🇺 Melbourne, Victoria, Australia