This Study Is To Estimate The Time Course Of Pf-04764793 In The Blood Following Dosing By Oral Inhalation From Dry Powder Inhalers

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Treatment F; Drug: Treatment C; Drug: Treatment D; Drug: Treatment A; Drug: Treatment B; Drug: Treatment G; Drug: Treatment E

• Registration Number: NCT01272375
• Lead Sponsor: Pfizer

Brief Summary

The purpose of this study is to investigate the time course of PF-04764793 concentration in the blood following dosing by oral inhalation from dry powder inhalers.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-01-06
• Study First Submitted QC: 2011-01-06
• Study First Posted: 2011-01-07
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-29
• Last Update Posted: 2018-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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/m^2; 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment F PF-04764793	Treatment F	PF-04764793 using inhaler B
Treatment C PF-04764793	Treatment C	PF-04764793 using inhaler A
Treatment D PF-04764793	Treatment D	PF-04764793 using inhaler A
Treatment A PF-04764793	Treatment A	PF-04764793 using inhaler A
Treatment B PF-04764793	Treatment B	PF-04764793 using inhaler A
Treatment G PF-04764793	Treatment G	PF-04764793 using inhaler B
Treatment E PF-04764793	Treatment E	PF-04764793 using inhaler B

Primary Outcome Measures

Name	Time	Method
Plasma pharmacokinetic parameter: Maximum concentration (Cmax) for PF-04764793 in plasma.	48 hours
Plasma pharmacokinetic parameter: Area under the curve (AUClast)from the time of dosing to the last data point taken for PF-04764793	48 hours

Secondary Outcome Measures

Name	Time	Method
Plasma pharmacokinetic parameter: Time of maximum (Tmax) concentration of PF-04764793 in plasma.	48 hours
Plasma pharmacokinetic parameter: Area under the curve (AUC0-24) from time of dosing to 24 hours post dose for PF-04764793.	48 hours
Plasma pharmacokinetic parameter: Area under the curve (AUCinf) from the time of dosing extrapolated to infinity for PF-04764793.	48 hours
Plasma pharmacokinetic parameter: Terminal half-life of PF-04764793.	48 hours

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇸🇬 Singapore, Singapore