Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of BMS-708163

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Alzheimer's Disease

Treatments: Drug: Placebo; Drug: BMS-708163

Study type: Interventional

Funder types: Industry

Identifiers

NCT01079819

CN156-029

Details and patient eligibility

About

The purpose of the study is to evaluate the pharmacokinetics, safety and tolerability of BMS-708163 administered as single and multiple doses in Chinese subjects

Enrollment: 32 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Healthy male subjects 18-45 yrs old and 65 yrs or older inclusive and postmenopausal female 65 yrs or older

Exclusion criteria

• Women of childbearing potential
• Gastrointestinal disorders
• Bleeding disorders
• Peptic ulcer disease
• Abnormal ECG
• Abnormal Clinical laboratory tests
• Abnormal Thyroid
• Congestive heart failure
• Cholecystectomy
• Asthma
• Hypertension
• Inability to tolerate oral medication
• Inability to be venipunctured and/or tolerate venous access

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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32 participants in 4 patient groups, including a placebo group

A1 (BMS-708163)

Active Comparator group

Treatment:

Drug: BMS-708163

Drug: BMS-708163

A2 (Placebo)

Placebo Comparator group

Treatment:

Drug: Placebo

Drug: Placebo

B1 (BMS-708163)

Active Comparator group

Treatment:

Drug: BMS-708163

Drug: BMS-708163

B2 (Placebo)

Placebo Comparator group

Treatment:

Drug: Placebo

Drug: Placebo