Multiple Dose Japanese Bridging Study | NCT01057030

Studies
Multiple Dose Japanese Bridging Study

NCT01057030

Sponsor

Bristol-Myers Squibb

Status

Completed

Last Update Posted

Jan 25, 2011Estimated

Enrollment

22Actual

Phase

Phase 1

Conditions

Alzheimer Disease

Interventions

BMS-708163
Placebo

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

Jun 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

Mar 2010

Primary Completion Date

Jun 2010Actual

Completion Date

Jun 2010Actual

First Submitted Date

Jan 26, 2010

First Submission Date that Met QC Criteria

Jan 26, 2010

First Posted Date

Jan 27, 2010Estimated

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 this study is to assess the safety and tolerability of multiple oral daily doses of BMS-708163 in healthy young male subjects

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

22Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A1 (BMS-708163)	Active Comparator	Healthy Japanese Subjects	Drug: BMS-708163
A2 (Placebo)	Placebo Comparator	Healthy Japanese Subjects	Drug: Placebo
B1 (BMS-708163)	Active Comparator	Healthy Non-Japanese Subjects	Drug: BMS-708163
B2 (Placebo)	Placebo Comparator	Healthy Non-Japanese Subjects	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
BMS-708163	Drug	Capsules, Oral, 125 mg, once daily, 14 days	A1 (BMS-708163) B1 (BMS-708163)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
BMS-708163 or placebo in Japanese and non-Japanese: Safety and tolerability (AE's, ECG, vital signs, safety labs)		Every day for 28 days

Secondary Outcomes

Measure	Description	Time Frame
BMS-708163 pharmacokinetic parameters (Cmax, Cmin, Ctrough, Tmax, AUC(TAU), AI, and CLT/F and T-HALF (only following Day 14 dose))		Days 1, 7, and 14

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy Japanese and non-Japanese subjects
Japanese subjects must be first generation Japanese and must demonstrate both maternal and paternal Japanese ancestry
Non-Japanese subjects must not be of Japanese or Asian descent, ie, neither parent nor grandparent was born in Japan or in any Asian country
BMI of 19 to 25 kg/m², for Japanese and non-Japanese subjects
Men ages 20 to 45 years

Exclusion Criteria:

Serum creatinine values above the normal range
Urine protein or blood levels above the normal range
Liver function tests above the normal range
TSH, free T3, or free T4 outside the normal range
Amylase or lipase levels above the normal range
Positive Fecal Immunochemical Test (FIT™)

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

45 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
California Clinical Trials Medical Group		Glendale	California	91206	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
C554092	BMS 708163

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided