Multiple-Ascending Dose Study

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Depression

Treatments: Drug: BMS-820836; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00892840

2008-008488-86

CN162-002

Details and patient eligibility

About

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

Enrollment: 57 patients

Sex: All

Ages: 21 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Panels 1-6: Healthy Male Subjects
• Panel 7: Females
• Ages 21 to 55, inclusive
• Body Mass Index (BMI) of 18 to 32 kg/m2, inclusive
• Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations

Exclusion criteria

• Any major surgery within 4 weeks of study drug administration
• History of cholecystectomy
• History of glaucoma or a confirmed intraocular pressure indicative of glaucoma at screening. (Normal IOP <21 mmHg)
• Confirmed QTc (Fridericia) value ≥ 450 msec
• Confirmed QT ≥ 500 msec
• Confirmed PR ≥ 210 msec
• Confirmed QRS ≥ 120 msec
• Confirmed resting supine systolic blood pressure > 140 mmHg
• Confirmed resting supine diastolic blood pressure > 90 mmHg
• Confirmed resting heart rate < 45 bpm or > 100 bpm
• Orthostatic vital sign changes (ie., a decrease in systolic blood pressure from supine to standing > 40 mmHg and an increase in heart rate from supine to standing > 20 bpm) or symptoms of orthostasis
• History of peppermint allergies
• Exposure to any investigational drug or placebo within 12 weeks of study drug administration

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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57 participants in 1 patient group

Panels 1 to 7 (BMS-820836 or Placebo)

Experimental group

Treatment:

Drug: Placebo

Drug: BMS-820836