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Safety and Pharmacology Study of BMS-866949

Primary Purpose

Major Depression

Status
Terminated
Phase
Phase 1
Locations
Sweden
Study Type
Interventional
Intervention
Placebo
BMS-866949
BMS-866949
BMS-866949
BMS-866949
BMS-866949
BMS-866949
BMS-866949
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depression

Eligibility Criteria

21 Years - 55 Years (Adult)All SexesAccepts 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:

  • 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

Sites / Locations

  • Local Institution

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Placebo or BMS-866949 (3 mg)

Placebo or BMS-866949 (10 mg)

Placebo or BMS-866949 (30 mg)

Placebo or BMS-866949 (45 mg)

Placebo or BMS-866949 (60 mg)

Placebo or BMS-866949 (90 mg)

Placebo or BMS-866949 (3 - 60 mg)

Arm Description

Panel 1: Healthy Male Subjects

Panel 2: Healthy Male Subjects

Panel 3: Healthy Male Subjects

Panel 4: Healthy Male Subjects

Panel 5: Healthy Male Subjects

Panel 6: Healthy Male Subjects

Panel 7: Females

Outcomes

Primary Outcome Measures

Assessment of safety by evaluating incidence of adverse events (AE)

Secondary Outcome Measures

Assessment of pharmacokinetics by evaluating plasma concentration versus time data
Assessment of pharmacodynamics by evaluating brain transporter occupancy

Full Information

First Posted
May 13, 2010
Last Updated
March 26, 2012
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT01124344
Brief Title
Safety and Pharmacology Study of BMS-866949
Official Title
Placebo-Controlled, Ascending Multiple-Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BMS-866949 in Healthy Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Terminated
Study Start Date
May 2010 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
November 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
47 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo or BMS-866949 (3 mg)
Arm Type
Active Comparator
Arm Description
Panel 1: Healthy Male Subjects
Arm Title
Placebo or BMS-866949 (10 mg)
Arm Type
Active Comparator
Arm Description
Panel 2: Healthy Male Subjects
Arm Title
Placebo or BMS-866949 (30 mg)
Arm Type
Active Comparator
Arm Description
Panel 3: Healthy Male Subjects
Arm Title
Placebo or BMS-866949 (45 mg)
Arm Type
Active Comparator
Arm Description
Panel 4: Healthy Male Subjects
Arm Title
Placebo or BMS-866949 (60 mg)
Arm Type
Active Comparator
Arm Description
Panel 5: Healthy Male Subjects
Arm Title
Placebo or BMS-866949 (90 mg)
Arm Type
Active Comparator
Arm Description
Panel 6: Healthy Male Subjects
Arm Title
Placebo or BMS-866949 (3 - 60 mg)
Arm Type
Active Comparator
Arm Description
Panel 7: Females
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral Solution, Oral, 0 mg, Once Daily, 14 days
Intervention Type
Drug
Intervention Name(s)
BMS-866949
Intervention Description
Oral Solution, Oral, 3 mg, Once Daily, 14 days
Intervention Type
Drug
Intervention Name(s)
BMS-866949
Intervention Description
Oral Solution, Oral, 10 mg, Once Daily, 14 days
Intervention Type
Drug
Intervention Name(s)
BMS-866949
Intervention Description
Oral Solution, Oral, 30 mg, Once Daily, 14 days
Intervention Type
Drug
Intervention Name(s)
BMS-866949
Intervention Description
Oral Solution, Oral, 45 mg, Once Daily, 14 days
Intervention Type
Drug
Intervention Name(s)
BMS-866949
Intervention Description
Oral Solution, Oral, 60 mg, Once Daily, 14 days
Intervention Type
Drug
Intervention Name(s)
BMS-866949
Intervention Description
Oral Solution, Oral, 90 mg, Once Daily, 14 days
Intervention Type
Drug
Intervention Name(s)
BMS-866949
Intervention Description
Oral Solution, Oral, 3-60 mg, Once Daily, 14 days
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Assessment of pharmacokinetics by evaluating plasma concentration versus time data
Time Frame
Over a period 28 days (+/- 2 days) of first dose
Title
Assessment of pharmacodynamics by evaluating brain transporter occupancy
Time Frame
Over a period 28 days (+/- 2 days) of first dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Local Institution
City
Uppsala
ZIP/Postal Code
751 23
Country
Sweden

12. IPD Sharing Statement

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Safety and Pharmacology Study of BMS-866949

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