Safety and Pharmacology Study of BMS-866949

Major Depression Clinical Trial

Official title:

Placebo-Controlled, Ascending Multiple-Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BMS-866949 in Healthy Subjects

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01124344
• Other study ID #: CN166-002
• Secondary ID: 2010-018461-38
• Status: Terminated
• Phase: Phase 1
• First received: May 13, 2010
• Last updated: March 26, 2012
• Start date: May 2010
• Est. completion date: November 2011

Study information

• Verified date: March 2012
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial Summary

The main purpose of this study is to determine whether multiple doses.of BMS-886949 are safe and tolerable

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 47
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• 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:

• History of glaucoma or a confirmed intraocular pressure indicative of glaucoma at screening. (Normal IOP <21 mmHg)

• History or family history of psychiatric disorder

• Current treatment with prescription medication

• 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, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depressive Disorder, Major
• Major Depression

Intervention

Drug:
• Placebo
Oral Solution, Oral, 0 mg, Once Daily, 14 days
• BMS-866949
Oral Solution, Oral, 3 mg, Once Daily, 14 days
• BMS-866949
Oral Solution, Oral, 10 mg, Once Daily, 14 days
• BMS-866949
Oral Solution, Oral, 30 mg, Once Daily, 14 days
• BMS-866949
Oral Solution, Oral, 45 mg, Once Daily, 14 days
• BMS-866949
Oral Solution, Oral, 60 mg, Once Daily, 14 days
• BMS-866949
Oral Solution, Oral, 90 mg, Once Daily, 14 days
• BMS-866949
Oral Solution, Oral, 3-60 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	Assessment of safety by evaluating incidence of adverse events (AE)		Over a period of 28 days (+/- 2 days) of first dose	Yes
Secondary	Assessment of pharmacokinetics by evaluating plasma concentration versus time data		Over a period 28 days (+/- 2 days) of first dose	No
Secondary	Assessment of pharmacodynamics by evaluating brain transporter occupancy		Over a period 28 days (+/- 2 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