Study to Evaluate the Safety, Pharmacokinetics and Tolerability of BMS-708163
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
1 other identifier
interventional
116
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jun 2007
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2009
CompletedFirst Submitted
Initial submission to the registry
October 7, 2011
CompletedFirst Posted
Study publicly available on registry
October 18, 2011
CompletedNovember 21, 2011
November 1, 2011
1.8 years
October 7, 2011
November 18, 2011
Conditions
Outcome Measures
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
Based on adverse event reports and the results of vital sign measurements, ECGs, physical examinations, and clinical laboratory tests
Within 28 days of dosing
Secondary Outcomes (9)
Effects of BMS-708163 on cortisol and QT interval corrected for heart rate
Within 28 days of dosing
Effect of BMS-708163 on thyroid stimulating hormone (TSH), free triiodothyronine (T3), free thyroxine (T4), and lymphocyte subsets
Within 28 days of dosing
Bioavailability of BMS-708163 from a capsule formulation relative to a solution formulation
Within 28 days of dosing
Effect of food on the PK of BMS-708163 administered as a capsule formulation
Within 28 days of dosing
Maximum observed plasma concentration (Cmax) of BMS-708163
Within 28 days of dosing
- +4 more secondary outcomes
Study Arms (14)
Panel 1: BMS-708163 or Placebo
EXPERIMENTALHealthy male subjects (age: 18 to 45 years)
Panel 2: BMS-708163 or Placebo
EXPERIMENTALHealthy male subjects (age: 18 to 45 years)
Panel 3: BMS-708163 or Placebo
EXPERIMENTALHealthy male subjects (age: 18 to 45 years)
Panel 4: BMS-708163 or Placebo
EXPERIMENTALHealthy male subjects (age: 18 to 45 years)
Panel 5: BMS-708163 or Placebo
EXPERIMENTALHealthy male subjects (age: 18 to 45 years). In Period 2: Subjects will receive BMS-708163 or placebo as a capsule formulation. In Period 3: Subjects will receive BMS-708163 or placebo as a capsule formulation within 5 minutes of consuming a standard high-fat breakfast on Day 1
Panel 6: BMS-708163 or Placebo
EXPERIMENTALHealthy male subjects (age: 18 to 45 years)
Panel 7: BMS-708163 or Placebo
EXPERIMENTALHealthy male subjects (age: 18 to 45 years)
Panel 8: BMS-708163 or Placebo
EXPERIMENTALHealthy male subjects (age: 18 to 45 years)
Panel 9: BMS-708163 or Placebo
EXPERIMENTALHealthy, elderly male subjects (age: 60 years and greater)
Panel 10: BMS-708163 or Placebo
EXPERIMENTALHealthy, elderly female subjects (age: 60 years and greater)
Panel 11: BMS-708163 or Placebo
EXPERIMENTALHealthy male subjects (age: between 46 to 59 years)
Panel 12: BMS-708163 or Placebo
EXPERIMENTALHealthy male and/or female subjects or subjects with MCI (age: between 60-74 years)
Panel 13: BMS-708163 or Placebo
EXPERIMENTALHealthy male and/or female subjects or with AD or MCI (age: 75 years or greater)
Panel 15: BMS-708163 or Placebo
EXPERIMENTALHealthy young male subjects
Interventions
Oral Solution, Oral, 0.3 mg, Once daily, once
Oral Solution, Oral, 0 mg, Once daily, once
Eligibility Criteria
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Tong G, Wang JS, Sverdlov O, Huang SP, Slemmon R, Croop R, Castaneda L, Gu H, Wong O, Li H, Berman RM, Smith C, Albright CF, Dockens RC. Multicenter, randomized, double-blind, placebo-controlled, single-ascending dose study of the oral gamma-secretase inhibitor BMS-708163 (Avagacestat): tolerability profile, pharmacokinetic parameters, and pharmacodynamic markers. Clin Ther. 2012 Mar;34(3):654-67. doi: 10.1016/j.clinthera.2012.01.022. Epub 2012 Feb 28.
PMID: 22381714DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 7, 2011
First Posted
October 18, 2011
Study Start
June 1, 2007
Primary Completion
March 1, 2009
Study Completion
March 1, 2009
Last Updated
November 21, 2011
Record last verified: 2011-11