A Four-Way Cross-Over Study To Compare The Plasma Concentrations Of PF-02413873 After Oral Administration Of Several Doses As Suspension And As Tablets.

Pfizer

Status and phase: Terminated; Phase 1

Conditions: Healthy

Treatments: Drug: 400 mg Suspension; Drug: 150 mg Tablet; Drug: 30 mg Tablet; Drug: 5 mg Tablet; Drug: 30 mg Suspension; Drug: 750 mg Suspension; Drug: 750 mg Tablet; Drug: 5 mg Suspension; Drug: 400 mg Tablet; Drug: 150 mg Suspension

Study type: Interventional

Funder types: Industry

Identifiers

NCT00857571

B0461003

Details and patient eligibility

About

The study compares the plasma concentrations of PF-02413873 after administration of several doses as suspension and as tablets

Enrollment: 12 patients

Sex: All

Ages: 21 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male and female volunteers.
• Female volunteers have to be of non-childbearing potential

Exclusion criteria

• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
• Any condition possibly affecting drug absorption (eg, gastrectomy).
• A positive urine drug screen.

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

Suspension

Experimental group

Description:

PF-02413873 suspension

Treatment:

Drug: 150 mg Suspension

Drug: 5 mg Suspension

Drug: 30 mg Suspension

Drug: 400 mg Suspension

Drug: 750 mg Suspension

Tablet

Experimental group

Description:

PF-02413873 Phase 2 Tablets

Treatment:

Drug: 5 mg Tablet

Drug: 400 mg Tablet

Drug: 750 mg Tablet

Drug: 30 mg Tablet

Drug: 150 mg Tablet