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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
  Purpose

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.


Condition Intervention Phase
Healthy
 Drug: PF-05180999
 Phase 1

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

Resource links provided by NLM:

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ]

Enrollment: 12
Study Start Date: January 2012
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PF-05180999 Immediate-Release Drug: PF-05180999
Single dose of 30 mg of PF-05180999 administered to fasted subjects as an immediate-release powder-in-capsule formulation
Experimental: PF-05180999 Modified-Release 1 Drug: PF-05180999
Single dose of 30 mg of PF-05180999 administered to fasted subjects as a modified-release formulation
Experimental: PF-05180999 Modified-Release 2 Drug: PF-05180999
Single dose of 120 mg of PF-05180999 administered to fasted subjects as a modified-release formulation
Experimental: PF-05180999 Modified-Release 1 With Food Drug: PF-05180999
Single dose of 30 mg of PF-05180999 administered to fed subjects as a modified-release formulation

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01530529

Locations
United States, Connecticut
Pfizer Investigational Site
New Haven, Connecticut, United States, 06511
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01530529     History of Changes
Other Study ID Numbers: B3441007, B3441007
Study First Received: February 7, 2012
Last Updated: April 29, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
PF-05180999
safety
pharmacokinetics
relative bioavailability
 Mental Disorders
Schizophrenia and Disorders with Psychotic Features
Schizophrenia

ClinicalTrials.gov processed this record on June 13, 2013