Multiple-Ascending Dose Study

• Status: Completed
• Trial end date: 2010-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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

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

Details

• Lead Sponsor: Bristol-Myers Squibb

Criteria

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