Study to Evaluate the Safety, Pharmacokinetics and Tolerability of BMS-708163
NCT01454115 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 116
Last updated 2011-11-21
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.
Conditions
Interventions
- DRUG
-
BMS-708163 (Gamma-Secretase Inhibitor)
Oral Solution, Oral, 0.3 mg, Once daily, once
- DRUG
-
BMS-708163 (Gamma-Secretase Inhibitor)
Oral Solution, Oral, 1.5 mg, Once daily, once
- DRUG
-
BMS-708163 (Gamma-Secretase Inhibitor)
Oral Solution, Oral, 5.0 mg, Once daily, once
- DRUG
-
BMS-708163 (Gamma-Secretase Inhibitor)
Oral Solution, Oral, 15.0 mg, Once daily, once
- DRUG
-
BMS-708163 (Gamma-Secretase Inhibitor)
Oral Solution, Oral, 50 mg, Once daily, once
- DRUG
-
BMS-708163 (Gamma-Secretase Inhibitor)
Oral Solution, Oral, 100 mg, Once daily, once
- DRUG
-
BMS-708163 (Gamma-Secretase Inhibitor)
Oral Solution, Oral, 200 mg, Once daily, once
- DRUG
-
BMS-708163 (Gamma-Secretase Inhibitor)
Oral Solution, Oral, 400 mg, Once daily, once
- DRUG
-
BMS-708163 (Gamma-Secretase Inhibitor)
Capsule, Oral, 50 mg, Once daily, once
- DRUG
-
BMS-708163 (Gamma-Secretase Inhibitor)
Oral Solution, Oral, 800 mg, Once daily, once
- DRUG
-
Placebo matching BMS-708163
Oral Solution, Oral, 0 mg, Once daily, once
- DRUG
-
Placebo matching BMS-708163
Capsule, Oral, 0 mg, Once daily, once
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Bristol-Myers Squibb · Bristol-Myers Squibb
Study Design
- Allocation
- RANDOMIZED
- Purpose
- BASIC_SCIENCE
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2007-06-30
- Primary Completion
- 2009-03-31
- Completion
- 2009-03-31
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