Relative Bioavailability Study of Four Experimental Formulations for Alzheimer's Disease

Healthy Clinical Trial

Official title:

A Bioavailability Study of Four Experimental BMS-708163 Formulations Relative to Solubilized Capsule Formulation in Healthy Young Male Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00901498
• Other study ID #: CN156-004
• Status: Completed
• Phase: Phase 1
• First received: May 5, 2009
• Last updated: January 6, 2011
• Start date: May 2009
• Est. completion date: July 2009

Study information

• Verified date: August 2009
• 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 purpose of this study is to assess the bioavailability of four experimental formulations relative to the current reference formulation used in the Phase 2 study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Young healthy male subjects

Exclusion Criteria:

• Women

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease
• Healthy

Intervention

Drug:
• BMS-708163
Oral, 25 mg Hard Gelatin Capsule, Size #2, 150 mg, Once per period of 3, 7 days between dosings. Will be compared with any 2 comparators.
• BMS-708163
Oral, 75 mg Tablet Formulation 1, 150 mg, Once per period of 3, 7 days between dosings
• BMS-708163
Oral, 50 mg Hard Gelatin Capsule, Size #0, 150 mg, Once per period of 3, 7 days between dosings
• BMS-708163
Oral, 75 mg Soft Gelatin Capsule, 150 mg, Once per period of 3, 7 days between dosings
• BMS-708163
Oral, 75 mg Tablet Formulation 2, 150 mg, Once per period of 3, 7 days between dosings

Locations

Country	Name	City	State
United States	Mds Pharma Services (Us) Inc.	Neptune	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the bioavailability of 4 experimental formulations relative to the current reference formulation		Day 1, up to 3 weeks	No
Secondary	Safety: Adverse Events		Day 1, up to 3 weeks	Yes
Secondary	Safety: Vital Signs		Screening, Day 1 and Day 4 of each period	Yes
Secondary	Safety: ECGs		Screening, Day 1 of each period, up to 3 weeks	Yes
Secondary	Safety: Clinical Lab Tests		Screening, Day -1 of each period, Day 1, up to 3 weeks	Yes

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm
•   Investigator Inquiry form