Multiple-Ascending Dose Study

Depression Clinical Trial

Official title:

Placebo-Controlled, Ascending Multiple-Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BMS-820836 in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00892840
• Other study ID #: CN162-002
• Secondary ID: 2008-008488-86
• Status: Completed
• Phase: Phase 1
• First received: May 2, 2009
• Last updated: February 10, 2011
• Start date: May 2009
• Est. completion date: November 2010

Study information

• Verified date: February 2011
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression

Intervention

Drug:
• BMS-820836
Oral Solution, Oral, 0.1 mg to 4 mg, Once daily, 14 days
• Placebo
Oral Solution, Oral, 0 mg, Once daily, 14 days

Locations

Country	Name	City	State
Sweden	Local Institution	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the safety and tolerability of BMS-820836 following multiple-dose administration		Within 27 days (+/- 2 days) of first dose	Yes
Secondary	To assess the pharmacodynamics of BMS-820836		Within 27 days of first dose	No

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm
•   Investigator Inquiry form