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NCT Number: NCT01646840

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

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.

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Key information

Conditions

Healthy Mental Disorders Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

New Haven, Connecticut, 06511, United States

About this study

This study was previously posted by Pfizer, Inc. Sponsorship of the trial was transferred to Biogen.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

PF-04958242 capsule

Drug

Single dose of PF-04958242 0.35 mg oral capsule

PF-04958242 oral solution

Drug

Single dose of PF-04958242 0.35 mg oral solution

Primary outcomes

  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 outcomes

  1. no secondary endpoints

    Time frame: no secondary endpoints

Sponsors and collaborators

Lead sponsor

Biogen

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jul 20, 2012
Registry last updated
Nov 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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