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A Study to Assess the Relative Bioavailability of a Modified-Release Formulation of PF-05180999

NCT ID: NCT01530529

Last Updated: 2012-05-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2012-04-30

Brief Summary

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The purpose of this study is to assess the bioavailability, safety, and tolerability of a modified-release formulation of PF-05180999 relative to an immediate-release formulation in healthy adult subjects. Two doses of the modified-release formulation and one dose of the immediate-release formulation will be evaluated under fasted conditions. One dose of the modified-release formulation will also be evaluated in the presence of food.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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PF-05180999 Immediate-Release

Group Type EXPERIMENTAL

PF-05180999

Intervention Type DRUG

Single dose of 30 mg of PF-05180999 administered to fasted subjects as an immediate-release powder-in-capsule formulation

PF-05180999 Modified-Release 1

Group Type EXPERIMENTAL

PF-05180999

Intervention Type DRUG

Single dose of 30 mg of PF-05180999 administered to fasted subjects as a modified-release formulation

PF-05180999 Modified-Release 2

Group Type EXPERIMENTAL

PF-05180999

Intervention Type DRUG

Single dose of 120 mg of PF-05180999 administered to fasted subjects as a modified-release formulation

PF-05180999 Modified-Release 1 With Food

Group Type EXPERIMENTAL

PF-05180999

Intervention Type DRUG

Single dose of 30 mg of PF-05180999 administered to fed subjects as a modified-release formulation

Interventions

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PF-05180999

Single dose of 30 mg of PF-05180999 administered to fasted subjects as an immediate-release powder-in-capsule formulation

Intervention Type DRUG

PF-05180999

Single dose of 30 mg of PF-05180999 administered to fasted subjects as a modified-release formulation

Intervention Type DRUG

PF-05180999

Single dose of 120 mg of PF-05180999 administered to fasted subjects as a modified-release formulation

Intervention Type DRUG

PF-05180999

Single dose of 30 mg of PF-05180999 administered to fed subjects as a modified-release formulation

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male or female of non-childbearing potential

Exclusion Criteria

* Evidence of clinically-significant medical illness, history of seizures, any condition possibly affecting drug absorption
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

New Haven, Connecticut, United States

Site Status

Countries

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United States

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B3441007&StudyName=A%20Study%20to%20Assess%20the%20Relative%20Bioavailability%20of%20a%20Modified-Release%20Formulation%20of%20PF-05180999

To obtain contact information for a study center near you, click here.

Other Identifiers

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B3441007

Identifier Type: -

Identifier Source: secondary_id

B3441007

Identifier Type: -

Identifier Source: org_study_id

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