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Multiple Dose Japanese Bridging Study

Bristol-Myers Squibb (BMS) logo

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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