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.

Phase 1

Completed

• Conditions: Phase 1; Single Dose; Safety; Toleration; Pharmacokinetics
• Interventions: Drug: PF-05212372; Drug: Placebo

• Registration Number: NCT01415102
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2010-09-29
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2011-08
• Study First Submitted QC: 2011-08-10
• Study First Posted: 2011-08-11
• Last Update Submitted: 2011-08-12
• Last Update Posted: 2011-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Cohort 1	Placebo	Subjects will be assigned to receive either PF-05212372 or placebo in each period
Cohort 2	PF-05212372	Subjects will be assigned to receive either PF-05212372 or placebo in each period
Cohort 2	Placebo	Subjects will be assigned to receive either PF-05212372 or placebo in each period
Cohort 1	PF-05212372	Subjects will be assigned to receive either PF-05212372 or placebo in each period

Primary Outcome Measures

Name	Time	Method
Urine pharmacokinetics	up to 24 hours post dose
Number of Participants with Adverse Events as a Measure of Safety and Tolerability	14 days
Plasma pharmacokinetics	up to 72 hours post dose
Urine Pharmacodynamics	up to 24 hours post dose

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇧🇪 Bruxelles, Belgium