Major Depression
Conditions
Brief summary
The main purpose of this study is to determine whether multiple doses.of BMS-886949 are safe and tolerable
Interventions
DRUGPlacebo
Oral Solution, Oral, 0 mg, Once Daily, 14 days
DRUGBMS-866949
Oral Solution, Oral, 3 mg, Once Daily, 14 days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
21 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of safety by evaluating incidence of adverse events (AE) | Over a period of 28 days (+/- 2 days) of first dose |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of pharmacokinetics by evaluating plasma concentration versus time data | Over a period 28 days (+/- 2 days) of first dose |
| Assessment of pharmacodynamics by evaluating brain transporter occupancy | Over a period 28 days (+/- 2 days) of first dose |
Countries
Sweden
Outcome results
None listed