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.

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01415102

Enrollment

Registered

2011-08-11

Start date

2010-09-30

Completion date

2010-12-31

Last updated

2011-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pharmacokinetics, Phase 1, Safety, Single Dose, Toleration

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.

Interventions

DRUGPF-05212372

Inhaled. Dose Level 1: 50 ug

DRUGPlacebo

Inhaled

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

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

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026