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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT01272375
First received: January 6, 2011
Last updated: May 11, 2011
Last verified: May 2011
  Purpose

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.


Condition Intervention Phase
Healthy
Drug: Treatment A
Drug: Treatment B
Drug: Treatment C
Drug: Treatment D
Drug: Treatment E
Drug: Treatment F
Drug: Treatment G
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: An Open Study To Estimate The Plasma Pharmacokinetics Of PF-04764793 Administered Via Oral Inhalation Using Dry Powder Inhalers

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Plasma pharmacokinetic parameter: Area under the curve (AUClast)from the time of dosing to the last data point taken for PF-04764793 [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
  • Plasma pharmacokinetic parameter: Maximum concentration (Cmax) for PF-04764793 in plasma. [ Time Frame: 48 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Plasma pharmacokinetic parameter: Area under the curve (AUC0-24) from time of dosing to 24 hours post dose for PF-04764793. [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
  • Plasma pharmacokinetic parameter: Area under the curve (AUCinf) from the time of dosing extrapolated to infinity for PF-04764793. [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
  • Plasma pharmacokinetic parameter: Time of maximum (Tmax) concentration of PF-04764793 in plasma. [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
  • Plasma pharmacokinetic parameter: Terminal half-life of PF-04764793. [ Time Frame: 48 hours ] [ Designated as safety issue: No ]

Enrollment: 48
Study Start Date: January 2011
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment A PF-04764793
PF-04764793 using inhaler A
Drug: Treatment A
PF-04764793 250/50 using inhaler A
Experimental: Treatment B PF-04764793
PF-04764793 using inhaler A
Drug: Treatment B
PF-04764793 250/50 using inhaler A
Experimental: Treatment C PF-04764793
PF-04764793 using inhaler A
Drug: Treatment C
PF-04764793 250/50 using inhaler A
Experimental: Treatment D PF-04764793
PF-04764793 using inhaler A
Drug: Treatment D
PF-04764793 250/50 using inhaler A
Experimental: Treatment E PF-04764793
PF-04764793 using inhaler B
Drug: Treatment E
PF-04764793 250/50 using inhaler B
Experimental: Treatment F PF-04764793
PF-04764793 using inhaler B
Drug: Treatment F
PF-04764793 250/50 using inhaler B
Experimental: Treatment G PF-04764793
PF-04764793 using inhaler B
Drug: Treatment G
PF-04764793 250/50 using inhaler B

  Eligibility

Ages Eligible for Study:   21 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01272375

Locations
Singapore
Pfizer Investigational Site
Singapore, Singapore, 188770
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT01272375     History of Changes
Other Study ID Numbers: B1691011
Study First Received: January 6, 2011
Last Updated: May 11, 2011
Health Authority: Singapore: Health Sciences Authority

ClinicalTrials.gov processed this record on September 16, 2014