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Completed

NCT Number: NCT01454115

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

The primary objective is to assess the safety and tolerability of a single oral dose of BMS-708163 in healthy young male subjects and in elderly male and female subjects.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Panels 1- 8 and Panels 14-15: healthy male subjects between the ages of 18 to 45
  • Panels 9 and 10: healthy elderly males and females ages 60 and greater
  • Panel 11: healthy males between the ages of 46-59
  • Panel 12: males and/or females either healthy or with mild cognitive impairment (MCI) between the ages of 60 and 74
  • Panel 13: males and/or females, healthy or with Alzheimer's disease (AD) or MCI that were 75 years of age or greater
  • Acceptable medical history, physical examinations, vital signs, electrocardiograms, hemoccult stool tests, and clinical laboratory evaluations

Treatment and study plan

BMS-708163 (Gamma-Secretase Inhibitor)

Drug

Oral Solution, Oral, 0.3 mg, Once daily, once

Placebo matching BMS-708163

Drug

Oral Solution, Oral, 0 mg, Once daily, once

Primary outcomes

  1. Safety and tolerability of Single doses of BMS-708163 in the range of 0.3 to 800 mg in the healthy subjects

    Time frame: Within 28 days of dosing

    Based on adverse event reports and the results of vital sign measurements, ECGs, physical examinations, and clinical laboratory tests

Secondary outcomes

  1. Effects of BMS-708163 on cortisol and QT interval corrected for heart rate

    Time frame: Within 28 days of dosing

  2. Effect of BMS-708163 on thyroid stimulating hormone (TSH), free triiodothyronine (T3), free thyroxine (T4), and lymphocyte subsets

    Time frame: Within 28 days of dosing

  3. Bioavailability of BMS-708163 from a capsule formulation relative to a solution formulation

    Time frame: Within 28 days of dosing

  4. Effect of food on the PK of BMS-708163 administered as a capsule formulation

    Time frame: Within 28 days of dosing

  5. Maximum observed plasma concentration (Cmax) of BMS-708163

    Time frame: Within 28 days of dosing

  6. Time of maximum observed plasma concentration (Tmax) of BMS-708163

    Time frame: Within 28 days of dosing

  7. Area under the plasma concentration-time curve from zero to the time of the last quantifiable concentration [AUC(0-T)] of BMS-708163

    Time frame: Within 28 days of dosing

  8. Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of BMS-708163

    Time frame: Within 28 days of dosing

  9. Plasma half-life (T-HALF) of BMS-708163

    Time frame: Within 28 days of dosing

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

Placebo-Controlled, Ascending Single-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-708163 in Healthy Male Subjects and a Comparison to Elderly Male and Female Subjects

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Oct 18, 2011
Registry last updated
Nov 21, 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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