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Study Of The PF-04958242 Blood Concentrations Of A Capsule Formulation Of PF-04958242 Compared To A Solution Formulation

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ClinicalTrials.gov Identifier: NCT01646840
Recruitment Status : Completed
First Posted : July 20, 2012
Last Update Posted : December 11, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This study will assess the relative bioavailability of a capsule formulation of PF-04958242, relative to a oral solution formulation of PF-04958242 in healthy adult subjects.

Condition or disease Intervention/treatment Phase
Healthy Drug: PF-04958242 capsule Drug: PF-04958242 oral solution Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: a Phase 1, Open-Label, Single Dose, Relative Bioavailability Study In Healthy Volunteers Comparing PF-04958242 Capsule Formulation To PF-04958242 Oral Solution In The Fasted State
Study Start Date : July 2012
Primary Completion Date : September 2012
Study Completion Date : September 2012
Arms and Interventions

Arm Intervention/treatment
Experimental: PF-04958242 capsule Drug: PF-04958242 capsule
Single dose of PF-04958242 0.35 mg oral capsule
Active Comparator: PF-04958242 oral solution Drug: PF-04958242 oral solution
Single dose of PF-04958242 0.35 mg oral solution


Outcome Measures

Primary Outcome Measures :
  1. Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) [ Time Frame: 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12, 24, 48, 72, 120, and 192 hours post-dose ]
  2. Maximum Observed Plasma Concentration (Cmax) [ Time Frame: 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12, 24, 48, 72, 120, and 192 hours post-dose ]
  3. Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04958242 [ Time Frame: 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12, 24, 48, 72, 120, and 192 hours post-dose ]
  4. Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] [ Time Frame: 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12, 24, 48, 72, 120, and 192 hours post-dose ]
  5. Plasma Decay Half-Life (t1/2) [ Time Frame: 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12, 24, 48, 72, 120, and 192 hours post-dose ]
  6. Apparent Oral Clearance (CL/F) [ Time Frame: 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12, 24, 48, 72, 120, and 192 hours post-dose ]
  7. Apparent Volume of Distribution (Vz/F) [ Time Frame: 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12, 24, 48, 72, 120, and 192 hours post-dose ]
  8. Number of Participants with categorical scores on the Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: 4 and 192 hours post-dose ]

Secondary Outcome Measures :
  1. no secondary endpoints [ Time Frame: no secondary endpoints ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male and/or female (of non childbearing potential) subjects between the ages of 18 and 55 years
  • Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).

Exclusion Criteria:

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease
  • Any condition possibly affecting drug absorption (eg, gastrectomy).
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01646840


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:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01646840     History of Changes
Other Study ID Numbers: B1701010
First Posted: July 20, 2012    Key Record Dates
Last Update Posted: December 11, 2012
Last Verified: December 2012

Keywords provided by Pfizer:
PF-04958242
bioequivalence
pharmacokinetics
Schizophrenia

Additional relevant MeSH terms:
Pharmaceutical Solutions