Alzheimer's Disease
Conditions
Brief summary
The primary objective is to assess the safety and tolerability of a single oral dose of BMS-708163 in healthy young male subjects and in elderly male and female subjects.
Interventions
DRUGBMS-708163 (Gamma-Secretase Inhibitor)
Oral Solution, Oral, 0.3 mg, Once daily, once
DRUGPlacebo matching BMS-708163
Oral Solution, Oral, 0 mg, Once daily, once
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Panels 1- 8 and Panels 14-15: healthy male subjects between the ages of 18 to 45 * Panels 9 and 10: healthy elderly males and females ages 60 and greater * Panel 11: healthy males between the ages of 46-59 * Panel 12: males and/or females either healthy or with mild cognitive impairment (MCI) between the ages of 60 and 74 * Panel 13: males and/or females, healthy or with Alzheimer's disease (AD) or MCI that were 75 years of age or greater * Acceptable medical history, physical examinations, vital signs, electrocardiograms, hemoccult stool tests, and clinical laboratory evaluations
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and tolerability of Single doses of BMS-708163 in the range of 0.3 to 800 mg in the healthy subjects | Within 28 days of dosing | Based on adverse event reports and the results of vital sign measurements, ECGs, physical examinations, and clinical laboratory tests |
Secondary
| Measure | Time frame |
|---|---|
| Effect of BMS-708163 on thyroid stimulating hormone (TSH), free triiodothyronine (T3), free thyroxine (T4), and lymphocyte subsets | Within 28 days of dosing |
| Bioavailability of BMS-708163 from a capsule formulation relative to a solution formulation | Within 28 days of dosing |
| Effect of food on the PK of BMS-708163 administered as a capsule formulation | Within 28 days of dosing |
| Maximum observed plasma concentration (Cmax) of BMS-708163 | Within 28 days of dosing |
| Effects of BMS-708163 on cortisol and QT interval corrected for heart rate | Within 28 days of dosing |
| Area under the plasma concentration-time curve from zero to the time of the last quantifiable concentration [AUC(0-T)] of BMS-708163 | Within 28 days of dosing |
| Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of BMS-708163 | Within 28 days of dosing |
| Plasma half-life (T-HALF) of BMS-708163 | Within 28 days of dosing |
| Time of maximum observed plasma concentration (Tmax) of BMS-708163 | Within 28 days of dosing |
Outcome results
None listed