A Study To Estimate The Time Course Of PF-00241939 Concentration In The Blood After Dosing With Oral Inhalation From Dry Powder Inhalers

Pfizer

Status and phase: Completed; Phase 1

Conditions: Pharmacokinetics

Treatments: Drug: Treatment F; Drug: Treatment B; Drug: Treatment A; Drug: Treatment C; Drug: Treatment G; Drug: Treatment E; Drug: Treatment D

Study type: Interventional

Funder types: Industry

Identifiers

NCT01181700

B0871015

Details and patient eligibility

About

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

Enrollment: 42 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).
• Pregnant or nursing females.
• 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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42 participants in 7 patient groups

Treatment A

Experimental group

Treatment:

Drug: Treatment A

Treatment B

Experimental group

Treatment:

Drug: Treatment B

Treatment C

Experimental group

Treatment:

Drug: Treatment C

Treatment D

Active Comparator group

Treatment:

Drug: Treatment D

Treatment E

Active Comparator group

Treatment:

Drug: Treatment E

Treatment F

Active Comparator group

Treatment:

Drug: Treatment F

Treatment G

Active Comparator group

Treatment:

Drug: Treatment G