Single Dose Study of BMS-820836

• Status: Completed
• Trial end date: 2009-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the safety and tolerability of BMS-820836 after single doses

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Bristol-Myers Squibb

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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