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

An Open Study To Estimate The Plasma Pharmacokinetics Of PF-04764793 Administered Via Oral Inhalation Using Dry Powder Inhalers

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01272375
Enrollment
48
Registered
2011-01-07
Start date
2011-01-31
Completion date
2011-05-31
Last updated
2018-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

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.

Interventions

DRUGTreatment A

PF-04764793 250/50 using inhaler A

DRUGTreatment B

PF-04764793 250/50 using inhaler A

DRUGTreatment C

PF-04764793 250/50 using inhaler A

DRUGTreatment D

PF-04764793 250/50 using inhaler A

DRUGTreatment E

PF-04764793 250/50 using inhaler B

DRUGTreatment F

PF-04764793 250/50 using inhaler B

DRUGTreatment G

PF-04764793 250/50 using inhaler B

Sponsors

Pfizer
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
21 Years to 55 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frame
Plasma pharmacokinetic parameter: Area under the curve (AUClast)from the time of dosing to the last data point taken for PF-0476479348 hours
Plasma pharmacokinetic parameter: Maximum concentration (Cmax) for PF-04764793 in plasma.48 hours

Secondary

MeasureTime frame
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: Time of maximum (Tmax) concentration of PF-04764793 in plasma.48 hours
Plasma pharmacokinetic parameter: Terminal half-life of PF-04764793.48 hours

Countries

Singapore

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026