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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.

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ClinicalTrials.gov Identifier: NCT01415102
Recruitment Status : Completed
First Posted : August 11, 2011
Last Update Posted : August 15, 2011
Sponsor:
Information provided by:
Pfizer

Brief Summary:
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 or disease Intervention/treatment Phase
Phase 1 Single Dose Safety Toleration Pharmacokinetics Drug: PF-05212372 Drug: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, 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
Study Start Date : September 2010
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 14 days ]
  2. Plasma pharmacokinetics [ Time Frame: up to 72 hours post dose ]
  3. Urine pharmacokinetics [ Time Frame: up to 24 hours post dose ]
  4. Urine Pharmacodynamics [ Time Frame: up to 24 hours post dose ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01415102


Locations
Belgium
Pfizer Investigational Site
Bruxelles, Belgium, B-1070
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT01415102     History of Changes
Other Study ID Numbers: B2031001
First Posted: August 11, 2011    Key Record Dates
Last Update Posted: August 15, 2011
Last Verified: August 2011