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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT01186757
First received: August 11, 2010
Last updated: January 11, 2011
Last verified: January 2011
  Purpose

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
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: Yes ]

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
Placebo

Detailed Description:

Healthy volunteer PK study

  Eligibility

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

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 ClinicalTrials.gov identifier: NCT01186757

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: NCT01186757     History of Changes
Other Study ID Numbers: A9111002
Study First Received: August 11, 2010
Last Updated: January 11, 2011
Health Authority: Singapore: Health Sciences Authority

ClinicalTrials.gov processed this record on October 29, 2014