Single Dose Study To Compare Pharmacokinietics Of 3 Diffe... | NCT01351129

Studies
Single Dose Study To Compare Pharmacokinietics Of 3 Different Formulations Of PF-04991532 In Healthy Volunteers

NCT01351129

Sponsor

Pfizer

Status

Completed

Last Update Posted

Jul 6, 2011Estimated

Enrollment

12Actual

Phase

Phase 1

Conditions

Healthy

Interventions

Formulation 1
Formulation 2
Formulation 3

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

Jul 2011

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

May 2011

Primary Completion Date

Jun 2011Actual

Completion Date

Jun 2011Actual

First Submitted Date

May 9, 2011

First Submission Date that Met QC Criteria

May 9, 2011

First Posted Date

May 10, 2011Estimated

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

Jul 5, 2011

Last Update Posted Date

Jul 6, 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 primary purpose of this study is to evaluate the pharmacokinetics, safety and tolerability three different formulations of PF-04991532 in healthy adult 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

12Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
Formulation 1	Experimental	Drug: Formulation 1
Formulation 2	Experimental	Drug: Formulation 2
Formulation 3	Experimental	Drug: Formulation 3

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Formulation 1	Drug	150-mg immediate release tablet (single dose)	Formulation 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Area under the plasma concentration versus time profile (AUC)		predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12,24,36,48 hrs postdose

Secondary Outcomes

Measure	Description	Time Frame
Max observed plasma concentration (Cmax)		predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12,24,36,48 hrs postdose
Time of Cmax (Tmax)		predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12,24,36,48 hrs postdose

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy male and/or female (non-childbearing potential) subjects between the ages of 21 and 55 years, inclusive.
Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
An informed consent document signed and dated by the subject.

Exclusion Criteria:

Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) disease or clinical findings at Screening.
Any condition possibly affecting drug absorption (eg, gastrectomy).
A positive urine drug screen.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 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
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