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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01272375
• Other study ID #: B1691011
• Status: Completed
• Phase: Phase 1
• Start date: January 2011
• Est. completion date: May 2011

Study information

• Verified date: November 2018
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Treatment A
PF-04764793 250/50 using inhaler A
• Treatment B
PF-04764793 250/50 using inhaler A
• Treatment C
PF-04764793 250/50 using inhaler A
• Treatment D
PF-04764793 250/50 using inhaler A
• Treatment E
PF-04764793 250/50 using inhaler B
• Treatment F
PF-04764793 250/50 using inhaler B
• Treatment G
PF-04764793 250/50 using inhaler B

Locations

Country	Name	City	State
Singapore	Pfizer Investigational Site	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma pharmacokinetic parameter: Area under the curve (AUClast)from the time of dosing to the last data point taken for PF-04764793		48 hours
Primary	Plasma pharmacokinetic parameter: Maximum concentration (Cmax) for PF-04764793 in plasma.		48 hours
Secondary	Plasma pharmacokinetic parameter: Area under the curve (AUC0-24) from time of dosing to 24 hours post dose for PF-04764793.		48 hours
Secondary	Plasma pharmacokinetic parameter: Area under the curve (AUCinf) from the time of dosing extrapolated to infinity for PF-04764793.		48 hours
Secondary	Plasma pharmacokinetic parameter: Time of maximum (Tmax) concentration of PF-04764793 in plasma.		48 hours
Secondary	Plasma pharmacokinetic parameter: Terminal half-life of PF-04764793.		48 hours

External Links

•   To obtain contact information for a study center near you, click here.