Single Dose Study of PF-05230907 in Healthy Japanese Subj... | NCT02537002

Studies
Single Dose Study of PF-05230907 in Healthy Japanese Subjects

NCT02537002

Sponsor

Pfizer

Status

Completed

Last Update Posted

Apr 29, 2016Estimated

Enrollment

17Actual

Phase

Phase 1

Conditions

Healthy

Interventions

PF-05230907
PF-05230907
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

Apr 2016

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

Sep 2015

Primary Completion Date

Mar 2016Actual

Completion Date

Mar 2016Actual

First Submitted Date

Aug 28, 2015

First Submission Date that Met QC Criteria

Aug 28, 2015

First Posted Date

Sep 1, 2015Estimated

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 28, 2016

Last Update Posted Date

Apr 29, 2016Estimated

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 the following:

To determine the safety and tolerability of single ascending intravenous (IV) doses of PF-05230907 in healthy Japanese subjects.
To characterize the PK profile of single ascending IV doses of PF-05230907 in healthy Japanese subjects.
To characterize the PD profiles of single ascending IV doses of PF-05230907 in healthy Japanese subjects.
To evaluate the immunogenicity of PF-05230907 in healthy Japanese 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

17Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cohort 1- PF-05230907 or Placebo	Experimental		Drug: PF-05230907 Drug: Placebo
Cohort 2- PF-05230907 or Placebo	Experimental		Drug: PF-05230907 Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PF-05230907	Drug	A single intravenous dose of 3 μg/kg	Cohort 1- PF-05230907 or Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of Adverse Events and Serious Adverse Events Per Participant of PF-05230907		up to 2 months

Secondary Outcomes

Measure	Description	Time Frame
Single dose Time to Reach maximum Observed Plasma Concentration (Tmax) of PF-05230907		Minute 0, 2, 5, 15, 40, 60 minute post-dose
Single dose Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]of PF-05230907		Minute 0, 2, 5, 15, 40, 60 minute post-dose

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy male of females
Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs) and <120 kg (265 lbs).
Japanese subjects who have four biologic Japanese grandparents born in Japan.

Exclusion Criteria:

Pregnant or nursing females.
Females of childbearing potential who are unwilling or unable to use an acceptable method of contraception.
Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 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
Pfizer CT.gov Call Center	Pfizer	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pfizer New Haven Clinical Research Unit		New Haven	Connecticut	06511-5473	United States

References Module

Citations

Not provided