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

Alzheimer's Disease Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01454115
• Other study ID #: CN156-001
• Status: Completed
• Phase: Phase 1
• First received: October 7, 2011
• Last updated: November 18, 2011
• Start date: June 2007
• Est. completion date: March 2009

Study information

• Verified date: November 2011
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• BMS-708163 (Gamma-Secretase Inhibitor)
Oral Solution, Oral, 0.3 mg, Once daily, once
• BMS-708163 (Gamma-Secretase Inhibitor)
Oral Solution, Oral, 1.5 mg, Once daily, once
• BMS-708163 (Gamma-Secretase Inhibitor)
Oral Solution, Oral, 5.0 mg, Once daily, once
• BMS-708163 (Gamma-Secretase Inhibitor)
Oral Solution, Oral, 15.0 mg, Once daily, once
• BMS-708163 (Gamma-Secretase Inhibitor)
Oral Solution, Oral, 50 mg, Once daily, once
• BMS-708163 (Gamma-Secretase Inhibitor)
Oral Solution, Oral, 100 mg, Once daily, once
• BMS-708163 (Gamma-Secretase Inhibitor)
Oral Solution, Oral, 200 mg, Once daily, once
• BMS-708163 (Gamma-Secretase Inhibitor)
Oral Solution, Oral, 400 mg, Once daily, once
• BMS-708163 (Gamma-Secretase Inhibitor)
Capsule, Oral, 50 mg, Once daily, once
• BMS-708163 (Gamma-Secretase Inhibitor)
Oral Solution, Oral, 800 mg, Once daily, once
• Placebo matching BMS-708163
Oral Solution, Oral, 0 mg, Once daily, once
• Placebo matching BMS-708163
Capsule, Oral, 0 mg, Once daily, once

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Effects of BMS-708163 on cortisol and QT interval corrected for heart rate		Within 28 days of dosing	Yes
Secondary	Effect of BMS-708163 on thyroid stimulating hormone (TSH), free triiodothyronine (T3), free thyroxine (T4), and lymphocyte subsets		Within 28 days of dosing	Yes
Secondary	Bioavailability of BMS-708163 from a capsule formulation relative to a solution formulation		Within 28 days of dosing	No
Secondary	Effect of food on the PK of BMS-708163 administered as a capsule formulation		Within 28 days of dosing	No
Secondary	Maximum observed plasma concentration (Cmax) of BMS-708163		Within 28 days of dosing	No
Secondary	Time of maximum observed plasma concentration (Tmax) of BMS-708163		Within 28 days of dosing	No
Secondary	Area under the plasma concentration-time curve from zero to the time of the last quantifiable concentration [AUC(0-T)] of BMS-708163		Within 28 days of dosing	No
Secondary	Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of BMS-708163		Within 28 days of dosing	No
Secondary	Plasma half-life (T-HALF) of BMS-708163		Within 28 days of dosing	No