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.

Pfizer

Status and phase: Completed; Phase 1

Conditions: Phase 1; Toleration; Single Dose; Pharmacokinetics; Safety

Treatments: Drug: PF-05212372; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01415102

B2031001

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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24 participants in 2 patient groups

Cohort 1

Experimental group

Description:

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

Treatment:

Drug: PF-05212372

Drug: PF-05212372

Drug: PF-05212372

Drug: Placebo

Drug: Placebo

Drug: PF-05212372

Drug: PF-05212372

Drug: PF-05212372

Drug: PF-05212372

Cohort 2

Experimental group

Description:

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

Treatment:

Drug: PF-05212372

Drug: PF-05212372

Drug: PF-05212372

Drug: Placebo

Drug: Placebo

Drug: PF-05212372

Drug: PF-05212372

Drug: PF-05212372

Drug: PF-05212372