Multiple Dose Safety Study of PF-04802540 in Healthy Volu... | NCT00756743

Studies
Multiple Dose Safety Study of PF-04802540 in Healthy Volunteers

NCT00756743

Sponsor

Taisho Pharmaceutical Co., Ltd.

Status

Completed

Last Update Posted

Mar 19, 2010Estimated

Enrollment

40Actual

Phase

Phase 1

Conditions

Healthy

Interventions

PF-04802540
Placebo

Countries

Singapore

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

Jan 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

Sep 2008

Primary Completion Date

Jan 2009Actual

Completion Date

Jan 2009Actual

First Submitted Date

Sep 19, 2008

First Submission Date that Met QC Criteria

Sep 19, 2008

First Posted Date

Sep 22, 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

Mar 17, 2010

Last Update Posted Date

Mar 19, 2010Estimated

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 multiple ascending doses of PF-04802540 administered orally to healthy adult subjects.

Detailed Description

Evaluation of safety and pharmacokinetics

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

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PF-04802540	Experimental		Drug: PF-04802540
Placebo	Placebo Comparator		Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PF-04802540	Drug	Multiple ascending doses for 10 days; planned doses include 5, 10 and 15 mg capsules q12 hours, doses may be adjusted based on accumulating data	PF-04802540

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Adverse events		12 days
Safety assessments: vital signs, ECG, physical examination, laboratory tests		12 days
Pharmacokinetics		12 days

Secondary Outcomes

Measure	Description	Time Frame
No secondary outcomes measures.		Timeframe N/A

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Males or females of non-childbearing capacity aged 21 to 55 years inclusive at screening.
Body mass index in the range of 18 to 30 kg/m2 and body weight>45 kg.
Healthy as determined by the investigator on the basis of screening evaluation.

Exclusion Criteria:

Use of prescription or nonprescription drugs
Any condition possibly affecting drug absorption

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

54 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 Investigational Site		Singapore		188770	Singapore

References Module

Citations

Not provided