A Study To Estimate The Time Course Of PF-00241939 Concentration In The Blood Following Dosing By Oral Inhalation From Dry Powder Inhalers. (B0871002)

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Treatment B; Drug: Treatment A; Drug: Treatment C

Study type: Interventional

Funder types: Industry

Identifiers

NCT00862667

B0871002

Details and patient eligibility

About

The purpose of this study is to investigate the time course of PF-00241939 concentration in the blood following dosing by oral inhalation from dry powder inhalers.

Enrollment: 36 patients

Sex: All

Ages: 21 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male and/or female subjects between the ages of 21 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 (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
• A positive urine drug screen.
• History of regular alcohol consumption exceeding 14 drinks/week for females or 21 drinks/week for males.
• Pregnant or nursing females.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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36 participants in 3 patient groups

Treatment A

Experimental group

Description:

PF-00241939 300ug using Inhaler A

Treatment:

Drug: Treatment A

Treatment B

Active Comparator group

Description:

PF-00241939 300ug using Inhaler B

Treatment:

Drug: Treatment B

Treatment C

Active Comparator group

Description:

PF-00241939 300ug using Inhaler C

Treatment:

Drug: Treatment C