Multiple Dose Japanese Bridging Study

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Alzheimer Disease

Treatments: Drug: Placebo; Drug: BMS-708163

Study type: Interventional

Funder types: Industry

Identifiers

NCT01057030

CN156-038

Details and patient eligibility

About

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

Enrollment: 22 patients

Sex: Male

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

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™)

Trial design

22 participants in 4 patient groups, including a placebo group

A1 (BMS-708163)

Active Comparator group

Description:

Healthy Japanese Subjects

Treatment:

Drug: BMS-708163

A2 (Placebo)

Placebo Comparator group

Description:

Healthy Japanese Subjects

Treatment:

Drug: Placebo

B1 (BMS-708163)

Active Comparator group

Description:

Healthy Non-Japanese Subjects

Treatment:

Drug: BMS-708163

B2 (Placebo)

Placebo Comparator group

Description:

Healthy Non-Japanese Subjects

Treatment:

Drug: Placebo