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
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.
Investigators
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