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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01646840

Enrollment

Registered

2012-07-20

Start date

2012-07-31

Completion date

2012-09-30

Last updated

2019-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

PF-04958242, bioequivalence, pharmacokinetics, Schizophrenia

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.

Detailed description

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

Interventions

DRUGPF-04958242 capsule

Single dose of PF-04958242 0.35 mg oral capsule

DRUGPF-04958242 oral solution

Single dose of PF-04958242 0.35 mg oral solution

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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).

Design outcomes

Primary

Measure	Time frame
Number of Participants with categorical scores on the Columbia Suicide Severity Rating Scale (C-SSRS)	4 and 192 hours post-dose
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

Secondary

Measure	Time frame
no secondary endpoints	no secondary endpoints

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026