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Clinical Trials/NCT01415102
NCT01415102
Completed
Phase 1

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

Pfizer1 site in 1 country24 target enrollmentSeptember 2010

Overview

Phase
Phase 1
Intervention
PF-05212372
Conditions
Phase 1
Sponsor
Pfizer
Enrollment
24
Locations
1
Primary Endpoint
Urine pharmacokinetics
Status
Completed
Last Updated
14 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2010
End Date
December 2010
Last Updated
14 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
Pfizer

Eligibility 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.

Arms & Interventions

Cohort 1

Subjects will be assigned to receive either PF-05212372 or placebo in each period

Intervention: PF-05212372

Cohort 1

Subjects will be assigned to receive either PF-05212372 or placebo in each period

Intervention: Placebo

Cohort 2

Subjects will be assigned to receive either PF-05212372 or placebo in each period

Intervention: PF-05212372

Cohort 2

Subjects will be assigned to receive either PF-05212372 or placebo in each period

Intervention: Placebo

Outcomes

Primary Outcomes

Urine pharmacokinetics

Time Frame: up to 24 hours post dose

Number of Participants with Adverse Events as a Measure of Safety and Tolerability

Time Frame: 14 days

Plasma pharmacokinetics

Time Frame: up to 72 hours post dose

Urine Pharmacodynamics

Time Frame: up to 24 hours post dose

Study Sites (1)

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