Drug-Drug Interaction to Study the Effect of BMS-708163 on Pharmacokinetics (PK) of Galantamine Extended Release (ER)

January 24, 2011 updated by: Bristol-Myers Squibb

A Study of the Effect of Concomitant Administration of Multiple Doses of BMS-708163 on the Pharmacokinetics of Galantamine in Healthy Subjects

The purpose of the study is to find out if the plasma concentration of galantamine extended release is changed when BMS-708163 is administered at the same time.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21225
        • Parexel International - Baltimore Epcu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy men and postmenopausal women

Exclusion Criteria:

  • Gastrointestinal disorders
  • Bleeding disorders
  • Peptic ulcer disease
  • Cholecystectomy
  • Seizure disorder
  • Asthma
  • Chronic obstructive pulmonary disease
  • Urinary tract obstruction
  • Cardiac conduction abnormalities, including but not limited to "sick sinus syndrome" and those with unexplained syncopal episodes
  • Inability to tolerate oral medication
  • Inability to be venipunctured and/or tolerate venous access

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: galantamine 8 mg (ER)
Drug: galantamine
Capsule, Oral, 8 mg (ER), once daily, Days 1-7
Other Names:
  • Razadyne ER ™
Drug: galantamine
Capsule, Oral, 16 mg (ER), once daily, Days 8-24
Other Names:
  • Razadyne ER ™
Active Comparator: galantamine 16 mg (ER)
Drug: galantamine
Capsule, Oral, 8 mg (ER), once daily, Days 1-7
Other Names:
  • Razadyne ER ™
Drug: galantamine
Capsule, Oral, 16 mg (ER), once daily, Days 8-24
Other Names:
  • Razadyne ER ™
Active Comparator: BMS-708163
Drug: BMS-708163
Capsule, Oral, 125 mg, once daily, Days 15-24

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Galantamine alone and with BMS-708163: Galantamine PK parameters (Cmax, Tmax, AUC(TAU) and Ctrough rations will be assessed without BMS-708163 Day 14) and with BMS708-163 (Ctrough Day 24)
Time Frame: Study Days 14 & 24
Study Days 14 & 24

Secondary Outcome Measures

Outcome Measure
Time Frame
Galantamine alone and with BMS 708163: Safety and tolerability (AE's, ECG, vital signs, safety labs)
Time Frame: Study Days 7, 14, 18, 25 and study discharge
Study Days 7, 14, 18, 25 and study discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

April 1, 2010

Study Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

December 22, 2009

First Submitted That Met QC Criteria

December 23, 2009

First Posted (Estimate)

December 24, 2009

Study Record Updates

Last Update Posted (Estimate)

January 25, 2011

Last Update Submitted That Met QC Criteria

January 24, 2011

Last Verified

February 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CN156-009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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