Alzheimer Disease
Conditions
Brief summary
The purpose of this study is to assess the safety and tolerability of multiple oral daily doses of BMS-708163 in healthy young male subjects
Interventions
DRUGBMS-708163
Capsules, Oral, 125 mg, once daily, 14 days
DRUGPlacebo
Capsules, Oral, 0 mg, once daily, 14 days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
20 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy Japanese and non-Japanese subjects * Japanese subjects must be first generation Japanese and must demonstrate both maternal and paternal Japanese ancestry * Non-Japanese subjects must not be of Japanese or Asian descent, ie, neither parent nor grandparent was born in Japan or in any Asian country * BMI of 19 to 25 kg/m², for Japanese and non-Japanese subjects * Men ages 20 to 45 years
Exclusion criteria
* Serum creatinine values above the normal range * Urine protein or blood levels above the normal range * Liver function tests above the normal range * TSH, free T3, or free T4 outside the normal range * Amylase or lipase levels above the normal range * Positive Fecal Immunochemical Test (FIT™)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| BMS-708163 or placebo in Japanese and non-Japanese: Safety and tolerability (AE's, ECG, vital signs, safety labs) | Every day for 28 days |
Secondary
| Measure | Time frame |
|---|---|
| BMS-708163 pharmacokinetic parameters (Cmax, Cmin, Ctrough, Tmax, AUC(TAU), AI, and CLT/F and T-HALF (only following Day 14 dose)) | Days 1, 7, and 14 |
Countries
United States
Outcome results
None listed