A First In Human Study In Healthy People To Evaluate Safety, Toleration And Time Course Of Plasma Concentration Of Single Inhaled Doses Of PF-05212372.

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT01415102
First received: September 29, 2010
Last updated: August 12, 2011
Last verified: August 2011
  Purpose

The purpose of this study in healthy people is to evaluate safety, toleration and time course of plasma concentration of single inhaled doses of PF-05212372.


Condition Intervention Phase
Phase 1
Single Dose
Safety
Toleration
Pharmacokinetics
Drug: PF-05212372
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: A Double Blind (3rd Party Open), Randomised, Placebo-Controlled, Dose Escalation Study To Investigate The Safety, Toleration, And Pharmacokinetics Of Single Inhaled Doses Of Pf-05212372 In Healthy Subjects

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
  • Plasma pharmacokinetics [ Time Frame: up to 72 hours post dose ] [ Designated as safety issue: No ]
  • Urine pharmacokinetics [ Time Frame: up to 24 hours post dose ] [ Designated as safety issue: No ]
  • Urine Pharmacodynamics [ Time Frame: up to 24 hours post dose ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: September 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1
Subjects will be assigned to receive either PF-05212372 or placebo in each period
Drug: PF-05212372
Inhaled. Dose Level 1: 50 ug
Drug: PF-05212372
Inhaled. Dose Level 2 - Dose to be selected based upon safety/tolerability/PK at preceding dose
Drug: PF-05212372
Inhaled. Dose Level 3 - Dose to be selected based upon safety/tolerability/PK at preceding dose
Drug: PF-05212372
Inhaled. Dose Level 4 - Dose to be selected based upon safety/tolerability/PK at preceding dose
Drug: Placebo
Inhaled
Experimental: Cohort 2
Subjects will be assigned to receive either PF-05212372 or placebo in each period
Drug: PF-05212372
Inhaled. Dose Level 5 - Dose to be selected based upon safety/tolerability/PK at preceding dose
Drug: PF-05212372
Inhaled. Dose Level 6 - Dose to be selected based upon safety/tolerability/PK at preceding dose
Drug: PF-05212372
Inhaled. Dose Level 7 - Dose to be selected based upon safety/tolerability/PK at preceding dose
Drug: Placebo
Inhaled

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Healthy subjects. (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).

Exclusion Criteria:

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
  • A positive urine drug screen.
  • Treatment with an investigational drug within the past 30 days (or local regulations) or 5 half-lives preceding the first dose of study medication.
  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: NCT01415102

Locations
Belgium
Pfizer Investigational Site
Bruxelles, Belgium, B-1070
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: NCT01415102     History of Changes
Other Study ID Numbers: B2031001
Study First Received: September 29, 2010
Last Updated: August 12, 2011
Health Authority: Belgium: FAMHP(Federal Agency for Medicines and Healthy Products)

ClinicalTrials.gov processed this record on October 29, 2014