Safety and Pharmacology Study of BMS-866949 - Full Text View

Purpose

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

Condition	Intervention	Phase
Major Depression	Drug: Placebo Drug: BMS-866949	Phase 1


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment
Official Title:	Placebo-Controlled, Ascending Multiple-Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BMS-866949 in Healthy Subjects

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

Assessment of safety by evaluating incidence of adverse events (AE) [ Time Frame: Over a period of 28 days (+/- 2 days) of first dose ]

Secondary Outcome Measures:

Assessment of pharmacokinetics by evaluating plasma concentration versus time data [ Time Frame: Over a period 28 days (+/- 2 days) of first dose ]
Assessment of pharmacodynamics by evaluating brain transporter occupancy [ Time Frame: Over a period 28 days (+/- 2 days) of first dose ]


Enrollment:	47
Study Start Date:	May 2010
Study Completion Date:	November 2011
Primary Completion Date:	November 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Placebo or BMS-866949 (3 mg) Panel 1: Healthy Male Subjects	Drug: Placebo Oral Solution, Oral, 0 mg, Once Daily, 14 days Drug: BMS-866949 Oral Solution, Oral, 3 mg, Once Daily, 14 days
Active Comparator: Placebo or BMS-866949 (10 mg) Panel 2: Healthy Male Subjects	Drug: Placebo Oral Solution, Oral, 0 mg, Once Daily, 14 days Drug: BMS-866949 Oral Solution, Oral, 10 mg, Once Daily, 14 days
Active Comparator: Placebo or BMS-866949 (30 mg) Panel 3: Healthy Male Subjects	Drug: Placebo Oral Solution, Oral, 0 mg, Once Daily, 14 days Drug: BMS-866949 Oral Solution, Oral, 30 mg, Once Daily, 14 days
Active Comparator: Placebo or BMS-866949 (45 mg) Panel 4: Healthy Male Subjects	Drug: Placebo Oral Solution, Oral, 0 mg, Once Daily, 14 days Drug: BMS-866949 Oral Solution, Oral, 45 mg, Once Daily, 14 days
Active Comparator: Placebo or BMS-866949 (60 mg) Panel 5: Healthy Male Subjects	Drug: Placebo Oral Solution, Oral, 0 mg, Once Daily, 14 days Drug: BMS-866949 Oral Solution, Oral, 60 mg, Once Daily, 14 days
Active Comparator: Placebo or BMS-866949 (90 mg) Panel 6: Healthy Male Subjects	Drug: Placebo Oral Solution, Oral, 0 mg, Once Daily, 14 days Drug: BMS-866949 Oral Solution, Oral, 90 mg, Once Daily, 14 days
Active Comparator: Placebo or BMS-866949 (3 - 60 mg) Panel 7: Females	Drug: Placebo Oral Solution, Oral, 0 mg, Once Daily, 14 days Drug: BMS-866949 Oral Solution, Oral, 3-60 mg, Once Daily, 14 days

Eligibility


Ages Eligible for Study:	21 Years to 55 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

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:

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01124344

Locations


Sweden
Local Institution
Uppsala, Sweden, 751 23

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators


Study Director:	Bristol-Myers Squibb	Bristol-Myers Squibb

More Information

Additional Information:

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

Investigator Inquiry form This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site


Responsible Party:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT01124344 History of Changes
Other Study ID Numbers:	CN166-002 2010-018461-38 ( EudraCT Number )
Study First Received:	May 13, 2010
Last Updated:	March 26, 2012

Additional relevant MeSH terms:


Depressive Disorder, Major Depressive Disorder Mood Disorders Mental Disorders

ClinicalTrials.gov processed this record on August 18, 2017