Single Dose Study of BMS-820836

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Depression

Treatments: Drug: Placebo; Drug: BMS-820836

Study type: Interventional

Funder types: Industry

Identifiers

NCT00964912

CN162-001

Details and patient eligibility

About

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

Enrollment: 68 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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68 participants in 11 patient groups

BMS-820836 (Part 1, Panel 1)

Active Comparator group

Treatment:

Drug: Placebo

Drug: BMS-820836

Drug: BMS-820836

Drug: BMS-820836

Drug: BMS-820836

Drug: BMS-820836

Drug: BMS-820836

Drug: BMS-820836

Drug: BMS-820836

Drug: BMS-820836

Drug: BMS-820836

Drug: BMS-820836

BMS-820836 (Part 1, Panel 2)

Active Comparator group

Treatment:

Drug: Placebo

Drug: BMS-820836

Drug: BMS-820836

Drug: BMS-820836

Drug: BMS-820836

Drug: BMS-820836

Drug: BMS-820836

Drug: BMS-820836

Drug: BMS-820836

Drug: BMS-820836

Drug: BMS-820836

Drug: BMS-820836

BMS-820836 (Part 1, Panel 3)

Active Comparator group

Treatment:

Drug: Placebo

Drug: BMS-820836

Drug: BMS-820836

Drug: BMS-820836

Drug: BMS-820836

Drug: BMS-820836

Drug: BMS-820836

Drug: BMS-820836

Drug: BMS-820836

Drug: BMS-820836

Drug: BMS-820836

Drug: BMS-820836

BMS-820836 (Part 1, Panel 4)

Active Comparator group

Treatment:

Drug: Placebo

Drug: BMS-820836

Drug: BMS-820836

Drug: BMS-820836

Drug: BMS-820836

Drug: BMS-820836

Drug: BMS-820836

Drug: BMS-820836

Drug: BMS-820836

Drug: BMS-820836

Drug: BMS-820836

Drug: BMS-820836

BMS-820836 (Part 1, Panel 5)

Active Comparator group

Treatment:

Drug: Placebo

Drug: BMS-820836

Drug: BMS-820836

Drug: BMS-820836

Drug: BMS-820836

Drug: BMS-820836

Drug: BMS-820836

Drug: BMS-820836

Drug: BMS-820836

Drug: BMS-820836

Drug: BMS-820836

Drug: BMS-820836

BMS-820836 (Part 1, Panel 6)

Active Comparator group

Treatment:

Drug: Placebo

Drug: BMS-820836

Drug: BMS-820836

Drug: BMS-820836

Drug: BMS-820836

Drug: BMS-820836

Drug: BMS-820836

Drug: BMS-820836

Drug: BMS-820836

Drug: BMS-820836

Drug: BMS-820836

Drug: BMS-820836

BMS-820836 (Part 1, Panel 7)

Active Comparator group

Treatment:

Drug: Placebo

Drug: BMS-820836

Drug: BMS-820836

Drug: BMS-820836

Drug: BMS-820836

Drug: BMS-820836

Drug: BMS-820836

Drug: BMS-820836

Drug: BMS-820836

Drug: BMS-820836

Drug: BMS-820836

Drug: BMS-820836

BMS-820836 (Part 1, Panel 8)

Active Comparator group

Treatment:

Drug: Placebo

Drug: BMS-820836

Drug: BMS-820836

Drug: BMS-820836

Drug: BMS-820836

Drug: BMS-820836

Drug: BMS-820836

Drug: BMS-820836

Drug: BMS-820836

Drug: BMS-820836

Drug: BMS-820836

Drug: BMS-820836

BMS-820836 (Part 1, Panel 9)

Active Comparator group

Treatment:

Drug: Placebo

Drug: BMS-820836

Drug: BMS-820836

Drug: BMS-820836

Drug: BMS-820836

Drug: BMS-820836

Drug: BMS-820836

Drug: BMS-820836

Drug: BMS-820836

Drug: BMS-820836

Drug: BMS-820836

Drug: BMS-820836

BMS-820836 (Part 2, Panel A)

Active Comparator group

Treatment:

Drug: BMS-820836

Drug: BMS-820836

Drug: BMS-820836

Drug: BMS-820836

Drug: BMS-820836

Drug: BMS-820836

Drug: BMS-820836

Drug: BMS-820836

Drug: BMS-820836

Drug: BMS-820836

Drug: BMS-820836

BMS-820836 (Part 2, Panel B)

Active Comparator group

Treatment:

Drug: BMS-820836

Drug: BMS-820836

Drug: BMS-820836

Drug: BMS-820836

Drug: BMS-820836

Drug: BMS-820836

Drug: BMS-820836

Drug: BMS-820836

Drug: BMS-820836

Drug: BMS-820836

Drug: BMS-820836