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

Biogen

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: PF-04958242 oral solution; Drug: PF-04958242 capsule

Study type: Interventional

Funder types: Industry

Identifiers

NCT01646840

B1701010

Details and patient eligibility

About

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.

Full description

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

Enrollment: 12 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

PF-04958242 capsule

Experimental group

Treatment:

Drug: PF-04958242 capsule

PF-04958242 oral solution

Active Comparator group

Treatment:

Drug: PF-04958242 oral solution