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

Alzheimer's Disease Clinical Trial

Official title:

Randomized, Placebo-controlled, Double-blind, Single- and Multiple-Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of BMS-708163 in Healthy Young Male and Elderly Male and Female Chinese Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01079819
• Other study ID #: CN156-029
• Status: Completed
• Phase: Phase 1
• First received: March 2, 2010
• Last updated: February 4, 2011
• Start date: April 2010
• Est. completion date: December 2010

Study information

• Verified date: February 2011
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• BMS-708163
Capsule, Oral, 50 mg, once daily, 1 Day
• BMS-708163
Capsule, Oral, 125 mg, once daily, 14 Days
• Placebo
Capsule, Oral, 0 mg, One daily, 1 Day
• Placebo
Capsule, Oral, 0 mg, One daily, 14 Day

Locations

Country	Name	City	State
United States	West Coast Clinical Trials, Llc	Cypress	California
United States	Iberica Clinical Research Center	Eatontown	New Jersey
United States	California Clinical Trials Medical Group	Glendale	California

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety assessments will be based on adverse event reports and the results of vital sign measurements, ECGs, physical exams and clinical laboratory tests. Adverse events will be tabulated and reviewed for potential significance and clinical importance		Study Day 1 through study completion + 30 days	Yes
Secondary	Single-dose pharmacokinetic parameters (Cmax, Tmax, AUC(0-T), AUC(INF), T-HALF and multiple-dose pk parameters (Cmax, Tmax, Cmin, AUC(TAU), T-HALF, and accumulation index will be derived from plasma concentration versus time data		Study Days 1-8 Period 1 and Days 1, 2, 5, 7, 9, 11, and 13-21 Period 2	No

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm
•   Investigator Inquiry form