A Phase 1 Study To Evaluate The Safety And Tolerability Of Different Doses Of PF-03526299 In Healthy Adult Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00990756
Recruitment Status : Completed
First Posted : October 7, 2009
Last Update Posted : January 22, 2010
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Brief Summary:
The purpose of this study is to investigate safety and toleration of multiple inhaled doses as well as the time course of PF-03526299 concentration in the blood following dosing by dry powder inhaler.

Condition or disease Intervention/treatment Phase
Healthy Drug: PF-03526299 Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: A Double Blind (3rd Party Open), Randomised, Placebo Controlled, Dose Escalation Study To Investigate The Safety, Toleration, And Pharmacokinetics Of Multiple Inhaled Doses Of PF-03526299 In Healthy Male Subjects
Study Start Date : November 2009
Actual Primary Completion Date : January 2010
Actual Study Completion Date : January 2010

Arm Intervention/treatment
Experimental: PF-03526299 1.396 mg Drug: PF-03526299
dry powder for inhalation, 1.396 mg, BID for 14 days

Experimental: PF-03526299 4mg Drug: PF-03526299
dry powder for inhalation, 4 mg, BID for 14 days

Primary Outcome Measures :
  1. Safety/toleration: Adverse events, vital signs, 12 lead ECG, blood and urine safety tests and physical examination. [ Time Frame: 17 days ]

Secondary Outcome Measures :
  1. Pharmacokinetic parameters: Plasma Day 1: Cmax, Tmax, AUCτau. [ Time Frame: Day 1 - 17 ]
  2. Plasma Day 7: Cmax, Tmax. [ Time Frame: 7 Days ]
  3. Plasma Day 14: Cmax, Tmax, CL/F, AUCτau, t½, accumulation ratio, time to steady state. [ Time Frame: 14 Days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Healthy male subjects and females of non-childbearing potential 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).
  • Subjects who had a normal chest X-ray in the previous 6 months prior to Screening

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 21 drinks/week for males and 14 drinks/week for females.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00990756

Pfizer Investigational Site
Singapore, Singapore, 188770
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc. Identifier: NCT00990756     History of Changes
Other Study ID Numbers: A9291003
First Posted: October 7, 2009    Key Record Dates
Last Update Posted: January 22, 2010
Last Verified: January 2010