Single Dose Study of BMS-820836
- Registration Number
- NCT00964912
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The purpose of this study is to determine the safety and tolerability of BMS-820836 after single doses
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 68
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BMS-820836 (Part 1, Panel 3) BMS-820836 - BMS-820836 (Part 1, Panel 2) BMS-820836 - BMS-820836 (Part 1, Panel 4) BMS-820836 - BMS-820836 (Part 1, Panel 7) BMS-820836 - BMS-820836 (Part 1, Panel 9) BMS-820836 - BMS-820836 (Part 1, Panel 8) Placebo - BMS-820836 (Part 1, Panel 5) BMS-820836 - BMS-820836 (Part 1, Panel 8) BMS-820836 - BMS-820836 (Part 1, Panel 2) Placebo - BMS-820836 (Part 1, Panel 4) Placebo - BMS-820836 (Part 1, Panel 6) Placebo - BMS-820836 (Part 1, Panel 7) Placebo - BMS-820836 (Part 1, Panel 1) BMS-820836 - BMS-820836 (Part 1, Panel 3) Placebo - BMS-820836 (Part 1, Panel 9) Placebo - BMS-820836 (Part 1, Panel 1) Placebo - BMS-820836 (Part 1, Panel 5) Placebo - BMS-820836 (Part 1, Panel 6) BMS-820836 - BMS-820836 (Part 2, Panel A) BMS-820836 - BMS-820836 (Part 2, Panel B) BMS-820836 -
- Primary Outcome Measures
Name Time Method To assess the safety and tolerability of BMS-820836 following single-dose administration Within 14 days of first dose
- Secondary Outcome Measures
Name Time Method To assess the single-dose pharmacokinetics of BMS-820836 and its N-demethylated metabolite BMS-821007 Within 7 days of dosing To assess the pharmacodynamics of BMS-820836 Within 48 hours of dosing
Trial Locations
- Locations (1)
Local Institution
🇨🇦Toronto, Ontario, Canada