Status:
COMPLETED
Single Dose Study of BMS-820836
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Depression
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to determine the safety and tolerability of BMS-820836 after single doses
Eligibility Criteria
Inclusion
- Body Mass Index (BMI) of 18 to 30 kg/m2, inclusive and weight ≥ 50 kg
- Right-handed, non-ambidextrous subjects for Part 2
- Men and women, ages 18 to 55 years, inclusive
Exclusion
- Women of child bearing potential (WOCBP) who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 8 weeks after the last dose of investigational product
- WOCBP using a prohibited contraceptive method
- Women who are pregnant or breastfeeding
- Sexually active fertile men not using effective birth control if their partners are WOCBP
- Any significant acute or chronic medical illness
- Current or recent (within 3 months) gastrointestinal disease
- History of cholecystectomy
- Any major surgery within 4 weeks of study drug administration
- Any gastrointestinal surgery that could impact the absorption of study drug
- Donation of blood or plasma to a blood bank or in a clinical study (except a screening visit) within 4 weeks of study drug administration
- Blood transfusion within 4 weeks of study drug administration
- Inability to tolerate/swallow oral medication
- Difficulty with venipuncture and/or poor venous access
- Self-reported smokers
- Recent (within 1 year) of psychostimulant use (cocaine, methylphenidate, amphetamines, ecstasy)
- Confirmed resting supine systolic blood pressure \> 130 mmHg
- Confirmed resting supine diastolic blood pressure \> 80 mmHg
- Confirmed QT value ≥ 500 msec
- Confirmed QTc (Bazett) value ≥ 450 msec
- History of any significant drug allergy (such as anaphylaxis or hepatotoxicity)
- History of peppermint allergies
- History of brain conditions (e.g. history of stroke, head trauma, etc.)
- History of or current psychiatric conditions
- History of claustrophobia
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT00964912
Start Date
July 1 2008
End Date
April 1 2009
Last Update
January 25 2011
Active Locations (1)
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1
Local Institution
Toronto, Ontario, Canada, M5V 2T3