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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Pfizer

ClinicalTrials.gov Identifier:

NCT01530529

First received: February 7, 2012

Last updated: April 29, 2012

Last verified: April 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

February 7, 2012

Last Updated Date

April 29, 2012

Start Date ^ICMJE

January 2012

Primary Completion Date

April 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Maximum Observed Plasma Concentration (Cmax) [ Time Frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48 hours post-dose of each Period ] [ Designated as safety issue: No ]
Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48 hours post-dose of each Period ] [ Designated as safety issue: No ]
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) [ Time Frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48 hours post-dose of each Period ] [ Designated as safety issue: No ]
Plasma Decay Half-Life (t1/2) [ Time Frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48 hours post-dose of each Period ] [ Designated as safety issue: No ]
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] [ Time Frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48 hours post-dose of each Period ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Plasma pharmacokinetics - Maximum plasma concentration, time to reach maximum plasma concentration, area under the curve, and half-life [ Time Frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48 hours post-dose of each Period ] [ Designated as safety issue: No ]

Change History

Complete list of historical versions of study NCT01530529 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

A Phase 1, Cross-Over, Single-Dose, Open-Label Study to Estimate the Relative Bioavailability of a Modified-Release Formulation of PF-05180999 Under Fed and Fasted Conditions in Healthy Adult Subjects

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science

Condition ^ICMJE

Healthy

Intervention ^ICMJE

Drug: PF-05180999
Single dose of 30 mg of PF-05180999 administered to fasted subjects as an immediate-release powder-in-capsule formulation
Drug: PF-05180999
Single dose of 30 mg of PF-05180999 administered to fasted subjects as a modified-release formulation
Drug: PF-05180999
Single dose of 120 mg of PF-05180999 administered to fasted subjects as a modified-release formulation
Drug: PF-05180999
Single dose of 30 mg of PF-05180999 administered to fed subjects as a modified-release formulation

Study Arm (s)

Experimental: PF-05180999 Immediate-Release
Intervention: Drug: PF-05180999
Experimental: PF-05180999 Modified-Release 1
Intervention: Drug: PF-05180999
Experimental: PF-05180999 Modified-Release 2
Intervention: Drug: PF-05180999
Experimental: PF-05180999 Modified-Release 1 With Food
Intervention: Drug: PF-05180999

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

April 2012

Primary Completion Date

April 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 55 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01530529

Other Study ID Numbers ^ICMJE

B3441007, B3441007

Has Data Monitoring Committee

Responsible Party

Pfizer

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

April 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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