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

• ClinicalTrials.gov Identifier: NCT01186757
• Recruitment Status: Completed
• First Posted: August 23, 2010
• Last Update Posted: January 12, 2011
• Sponsor: Pfizer
• Information provided by: Pfizer

Tracking Information

• First Submitted Date: August 11, 2010
• First Posted Date: August 23, 2010
• Last Update Posted Date: January 12, 2011
• Study Start Date: August 2010
• Actual Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: September 27, 2010): 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 ]
• Original Primary Outcome Measures (submitted: August 20, 2010): Pharmacokinetics of single and multiple inhaled doses of PF-03715455, as measured by plasma concentrations - Cmax, Tmax, AUCinf, AUC, t½, accumulation ratio (Rac, Rss, Rac,Cmax). [ Time Frame: 14 days ]
• Current Secondary Outcome Measures (submitted: September 27, 2010): 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 ]
• Original Secondary Outcome Measures (submitted: August 20, 2010): Safety and toleration as measured by adverse events, vital signs, 12 lead ECG, blood and urine safety tests and physical examination. [ Time Frame: 14 Days ]
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Multiple Dose Healthy Volunteer Study of PF-03715455.
• 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
• Brief Summary: Evaluation of the multiple dose pharmacokinetics of PF-3715455 in healthy volunteers
• Detailed Description: Healthy volunteer PK study
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Condition: Healthy Volunteers

Intervention

• Drug: PF-03715455
  PF-03715455 1.6 mg BID
• Drug: PF-03715455
  PF-03715455 4mg BID
• Drug: PF-03715455
  PF-03715455 10 mg BID
• Drug: Placebo
  Placebo

Study Arms

• Active Comparator: PF-03715455 1.6mg BID
  Intervention: Drug: PF-03715455
• Active Comparator: PF-03715455 4 mg BID
  Intervention: Drug: PF-03715455
• Active Comparator: PF-03715455 10 mg BID
  Intervention: Drug: PF-03715455
• Placebo Comparator: Placebo
  Intervention: Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 20, 2010): 36
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: January 2011
• Actual Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Healthy volunteers

Exclusion Criteria:

• Standard healthy volunteer criteria

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 21 Years to 55 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Singapore

Administrative Information

• NCT Number: NCT01186757
• Other Study ID Numbers: A9111002
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
• Study Sponsor: Pfizer
• Collaborators: Not Provided

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

• PRS Account: Pfizer
• Verification Date: January 2011