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

This study has been completed.
Information provided by:
Pfizer Identifier:
First received: August 11, 2010
Last updated: January 11, 2011
Last verified: January 2011
Evaluation of the multiple dose pharmacokinetics of PF-3715455 in healthy volunteers

Condition Intervention Phase
Healthy Volunteers Drug: PF-03715455 Drug: Placebo Phase 1

Study Type: Interventional
Study Design: 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

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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:
  • 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 ]

Enrollment: 36
Study Start Date: August 2010
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:
Healthy volunteer PK study

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
  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 identifier: NCT01186757

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

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc. Identifier: NCT01186757     History of Changes
Other Study ID Numbers: A9111002
Study First Received: August 11, 2010
Last Updated: January 11, 2011 processed this record on August 18, 2017