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
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 April 22, 2014