NCT01002079

Brief Summary

The purpose of the study is to determine if the concomitant administration of rifampin with BMS-708163 will affect the Pharmacokinetics of BMS-708163 and to assess safety and tolerability of co-administration BMS-708163 and rifampin

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1 alzheimer-disease

Timeline
Completed

Started Aug 2010

Shorter than P25 for phase_1 alzheimer-disease

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

October 26, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 27, 2009

Completed
9 months until next milestone

Study Start

First participant enrolled

August 1, 2010

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

January 25, 2011

Status Verified

November 1, 2010

Enrollment Period

2 months

First QC Date

October 26, 2009

Last Update Submit

January 24, 2011

Conditions

Alzheimer Disease

Outcome Measures

Primary Outcomes (1)

  • BMS-708163 alone and with rifampin: BMS-708163 single dose PK parameters (Cmax, Tmax, T-HALF, AUC(0-T), AUC(INF), CLT/F and molar AUCmet/AUCparent ratios will be assessed without rifampin (Day 1) and with rifampin (Day 13)

    Within 30 days after dose

Secondary Outcomes (1)

  • BMS-708163 alone and with rifampin: Safety and tolerability (AE's, ECG, vital signs, safety labs)

    Within 30 days after dose

Study Arms (3)

BMS-708163

EXPERIMENTAL
Drug: BMS-708163

Rifampin

OTHER
Drug: Rifampin

Rifampin + BMS-708163

EXPERIMENTAL
Drug: BMS-708163Drug: Rifampin

Interventions

BMS-708163DRUG

Capsule, Oral, 125 mg, Once daily, 1 day

BMS-708163Rifampin + BMS-708163
RifampinDRUG

Capsule, Oral, 600 mg, Once daily, 7 days

Rifampin

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male and postmenopausal female subjects, 18-55 yrs old inclusive

You may not qualify if:

  • Women of childbearing potential
  • Tuberculosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Local Institution

Bangalore, 560100, India

Location

Related Links

MeSH Terms

Conditions

Alzheimer Disease

Interventions

BMS 708163Rifampin

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

RifamycinsHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsLactams, MacrocyclicMacrocyclic CompoundsPolycyclic Compounds

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 26, 2009

First Posted

October 27, 2009

Study Start

August 1, 2010

Primary Completion

October 1, 2010

Study Completion

October 1, 2010

Last Updated

January 25, 2011

Record last verified: 2010-11

Locations

IN(1)