Drug-Drug Interaction to Study the Effect of BMS-708163 o... | NCT01039194

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

NCT01039194

Sponsor

Bristol-Myers Squibb

Status

Completed

Last Update Posted

Jan 25, 2011Estimated

Enrollment

18Actual

Phase

Phase 1

Conditions

Alzheimer Disease

Interventions

galantamine
galantamine
BMS-708163

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2010

Primary Completion Date

Apr 2010Actual

Completion Date

Apr 2010Actual

First Submitted Date

Dec 22, 2009

First Submission Date that Met QC Criteria

Dec 23, 2009

First Posted Date

Dec 24, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 24, 2011

Last Update Posted Date

Jan 25, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

18Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
galantamine 8 mg (ER)	Active Comparator	Drug: galantamine
galantamine 16 mg (ER)	Active Comparator	Drug: galantamine
BMS-708163	Active Comparator	Drug: BMS-708163

Interventions

Name	Type	Description	Arm Group Labels	Other Names
galantamine	Drug	Capsule, Oral, 8 mg (ER), once daily, Days 1-7	galantamine 8 mg (ER)

Outcomes Module

Primary Outcomes

Measure	Description	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)		Study Days 14 & 24

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bristol-Myers Squibb	Bristol-Myers Squibb	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Parexel International - Baltimore Epcu		Baltimore	Maryland	21225	United States

Condition Browse Module

MeSH Terms

ID	Term
D000544	Alzheimer Disease

Ancestor Terms

ID	Term
D003704	Dementia
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D005702	Galantamine
C554092	BMS 708163

Ancestor Terms

ID	Term
D047151	Amaryllidaceae Alkaloids
D000470	Alkaloids
D006571	Heterocyclic Compounds
D001552	Benzazepines

Browse Leaves

Not provided

Browse Branches

Not provided