NCT01646840

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Jul 2012

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

July 12, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 20, 2012

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

November 21, 2019

Status Verified

November 1, 2019

Enrollment Period

2 months

First QC Date

July 12, 2012

Last Update Submit

November 19, 2019

Conditions

Healthy

Keywords

PF-04958242bioequivalencepharmacokineticsSchizophrenia

Outcome Measures

Primary Outcomes (8)

  • Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)

    0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12, 24, 48, 72, 120, and 192 hours post-dose

  • Maximum Observed Plasma Concentration (Cmax)

    0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12, 24, 48, 72, 120, and 192 hours post-dose

  • Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04958242

    0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12, 24, 48, 72, 120, and 192 hours post-dose

  • Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]

    0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12, 24, 48, 72, 120, and 192 hours post-dose

  • Plasma Decay Half-Life (t1/2)

    0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12, 24, 48, 72, 120, and 192 hours post-dose

  • Apparent Oral Clearance (CL/F)

    0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12, 24, 48, 72, 120, and 192 hours post-dose

  • Apparent Volume of Distribution (Vz/F)

    0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12, 24, 48, 72, 120, and 192 hours post-dose

  • Number of Participants with categorical scores on the Columbia Suicide Severity Rating Scale (C-SSRS)

    4 and 192 hours post-dose

Secondary Outcomes (1)

  • no secondary endpoints

    no secondary endpoints

Study Arms (2)

PF-04958242 capsule

EXPERIMENTAL
Drug: PF-04958242 capsule

PF-04958242 oral solution

ACTIVE COMPARATOR
Drug: PF-04958242 oral solution

Interventions

PF-04958242 capsuleDRUG

Single dose of PF-04958242 0.35 mg oral capsule

PF-04958242 capsule
PF-04958242 oral solutionDRUG

Single dose of PF-04958242 0.35 mg oral solution

PF-04958242 oral solution

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pfizer Investigational Site

New Haven, Connecticut, 06511, United States

Location

Related Links

MeSH Terms

Conditions

Schizophrenia

Interventions

PF-04958242

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Medical Director

    Biogen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 12, 2012

First Posted

July 20, 2012

Study Start

July 1, 2012

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

November 21, 2019

Record last verified: 2019-11

Locations

US(1)