Multiple Dose Healthy Volunteer Study of PF-03715455. (MD-MULTI DOSE)

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: NCT01186757
Recruitment Status : Completed
First Posted : August 23, 2010
Last Update Posted : January 12, 2011
Information provided by:

Brief Summary:
Evaluation of the multiple dose pharmacokinetics of PF-3715455 in healthy volunteers

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: PF-03715455 Drug: Placebo Phase 1

Detailed Description:
Healthy volunteer PK study

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Official Title: A Double Blind (3rd Party Open), Randomized, Placebo Controlled, Dose Escalation Study To Investigate The Safety, Toleration, And Pharmacokinetics Of Multiple Inhaled Doses Of PF-03715455 In Healthy Subjects
Study Start Date : August 2010
Actual Primary Completion Date : January 2011
Actual Study Completion Date : January 2011

Arm Intervention/treatment
Active Comparator: PF-03715455 1.6mg BID Drug: PF-03715455
PF-03715455 1.6 mg BID
Active Comparator: PF-03715455 4 mg BID Drug: PF-03715455
PF-03715455 4mg BID
Active Comparator: PF-03715455 10 mg BID Drug: PF-03715455
PF-03715455 10 mg BID
Placebo Comparator: Placebo Drug: Placebo

Primary Outcome Measures :
  1. Pharmacokinetics of single and multiple inhaled doses of PF-03715455, as measured by plasma concentrations - Cmax, Tmax, AUCtau, t½, accumulation ratio (Rac, Rss, Rac,Cmax). [ Time Frame: 17 days ]

Secondary Outcome Measures :
  1. Safety and toleration as measured by adverse events, vital signs, 12 lead ECG, blood and urine safety tests and physical examination. [ Time Frame: 28 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 volunteers

Exclusion Criteria:

  • Standard healthy volunteer criteria

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): NCT01186757

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: NCT01186757     History of Changes
Other Study ID Numbers: A9111002
First Posted: August 23, 2010    Key Record Dates
Last Update Posted: January 12, 2011
Last Verified: January 2011