Study Evaluating the Safety and Pharmacokinetics (PK) of... | NCT00722202

Studies
Study Evaluating the Safety and Pharmacokinetics (PK) of Ascending Single IV Doses of ERB-257 in Healthy Japanese Males

NCT00722202

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Status

Completed

Last Update Posted

Apr 28, 2009Estimated

Enrollment

48Actual

Phase

Phase 1

Conditions

Healthy Subjects

Interventions

ERB-257
placebo

Countries

Japan

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

Apr 2009

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

Oct 2008

Primary Completion Date

Nov 2008Actual

Completion Date

Nov 2008Actual

First Submitted Date

Jul 23, 2008

First Submission Date that Met QC Criteria

Jul 24, 2008

First Posted Date

Jul 25, 2008Estimated

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

Apr 24, 2009

Last Update Posted Date

Apr 28, 2009Estimated

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 evaluate the safety, tolerability, and pharmacokinetics of IV administered ERB-257 as single ascending doses to healthy Japanese 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

48Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ERB-257	Active Comparator	7 IV single doses of ERB-257 will be given to 6 healthy subjects per group - 1, 4, 15, 45, 90, 180, and 300 mg	Drug: ERB-257
placebo	Placebo Comparator	2 placebo subjects per group	Other: placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ERB-257	Drug		ERB-257
placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To evaluate the safety and tolerability of ERB-257 as a single IV dose		4 days

Secondary Outcomes

Measure	Description	Time Frame
To evaluate the pharmacokinetics of ERB-257 as a single IV dose		4 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy Japanese men between the ages of 20 and 50.
Body mass index (BMI) in the range of 17.6 to 26.4 kg/m2 and body weight greater than or equal to 45 kg2.
Have a high probability for compliance with and completion of the study.

Exclusion Criteria:

Presence or history of any disorder that may prevent the successful completion of the study.
Acute disease state (eg, nausea, vomiting, infection, fever, or diarrhea) within 7 days before study day 1.

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Medical Monitor	Wyeth is now a wholly owned subsidiary of Pfizer	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sekino Clinical Pharmacology Clinic		Tokyo		1710014	Japan