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Completed

NCT Number: NCT01057030

Multiple Dose Japanese Bridging Study

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

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Key information

Conditions

Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

20 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

California Clinical Trials Medical Group

Glendale, California, 91206, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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™)

Treatment and study plan

BMS-708163

Drug

Capsules, Oral, 125 mg, once daily, 14 days

Other names: (GAMMA SECRETASE inhibitor)

Placebo

Drug

Capsules, Oral, 0 mg, once daily, 14 days

Primary outcomes

  1. BMS-708163 or placebo in Japanese and non-Japanese: Safety and tolerability (AE's, ECG, vital signs, safety labs)

    Time frame: Every day for 28 days

Secondary outcomes

  1. BMS-708163 pharmacokinetic parameters (Cmax, Cmin, Ctrough, Tmax, AUC(TAU), AI, and CLT/F and T-HALF (only following Day 14 dose))

    Time frame: Days 1, 7, and 14

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Jan 27, 2010
Registry last updated
Jan 25, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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