Multiple Dose Japanese Bridging Study

Alzheimer Disease Clinical Trial

Official title:

Randomized, Double-Blinded, Placebo-Controlled, Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-708163 125 mg in Healthy Japanese and Non-Japanese Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01057030
• Other study ID #: CN156-038
• Status: Completed
• Phase: Phase 1
• First received: January 26, 2010
• Last updated: January 24, 2011
• Start date: March 2010
• Est. completion date: June 2010

Study information

• Verified date: June 2010
• 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 this study is to assess the safety and tolerability of multiple oral daily doses of BMS-708163 in healthy young male subjects

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 45 Years

Eligibility

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™)

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Drug:
• BMS-708163
Capsules, Oral, 125 mg, once daily, 14 days
• Placebo
Capsules, Oral, 0 mg, once daily, 14 days

Locations

Country	Name	City	State
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	BMS-708163 or placebo in Japanese and non-Japanese: Safety and tolerability (AE's, ECG, vital signs, safety labs)		Every day for 28 days	Yes
Secondary	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	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