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
  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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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 October 23, 2014