Depression
Conditions
Brief summary
The purpose of this study is to determine the safety and tolerability of BMS-820836 after single doses
Interventions
DRUGBMS-820836
Oral Solution, Oral, 0.025 mg, single dose, one dose
DRUGPlacebo
Oral Solution, Oral, 0 mg, single dose, one dose
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the safety and tolerability of BMS-820836 following single-dose administration | Within 14 days of first dose |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Canada
Outcome results
None listed