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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00901498

Enrollment

Registered

2009-05-13

Start date

2009-05-31

Completion date

2009-07-31

Last updated

2011-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer's Disease, Healthy

Brief 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.

Interventions

DRUGBMS-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.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

* Young healthy male subjects

Exclusion criteria

* Women

Design outcomes

Primary

Measure	Time frame
To assess the bioavailability of 4 experimental formulations relative to the current reference formulation	Day 1, up to 3 weeks

Secondary

Measure	Time frame
Safety: Adverse Events	Day 1, up to 3 weeks
Safety: Vital Signs	Screening, Day 1 and Day 4 of each period
Safety: ECGs	Screening, Day 1 of each period, up to 3 weeks
Safety: Clinical Lab Tests	Screening, Day -1 of each period, Day 1, up to 3 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026