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.

Pharmacokinetics Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01415102
• Other study ID #: B2031001
• Status: Completed
• Phase: Phase 1
• First received: September 29, 2010
• Last updated: August 12, 2011
• Start date: September 2010
• Est. completion date: December 2010

Study information

• Verified date: August 2011
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: FAMHP(Federal Agency for Medicines and Healthy Products)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Pharmacokinetics
• Phase 1
• Safety
• Single Dose
• Toleration

Intervention

Drug:
• PF-05212372
Inhaled. Dose Level 1: 50 ug
• PF-05212372
Inhaled. Dose Level 2 - Dose to be selected based upon safety/tolerability/PK at preceding dose
• PF-05212372
Inhaled. Dose Level 3 - Dose to be selected based upon safety/tolerability/PK at preceding dose
• PF-05212372
Inhaled. Dose Level 4 - Dose to be selected based upon safety/tolerability/PK at preceding dose
• Placebo
Inhaled
• PF-05212372
Inhaled. Dose Level 5 - Dose to be selected based upon safety/tolerability/PK at preceding dose
• PF-05212372
Inhaled. Dose Level 6 - Dose to be selected based upon safety/tolerability/PK at preceding dose
• PF-05212372
Inhaled. Dose Level 7 - Dose to be selected based upon safety/tolerability/PK at preceding dose
• Placebo
Inhaled

Locations

Country	Name	City	State
Belgium	Pfizer Investigational Site	Bruxelles

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Adverse Events as a Measure of Safety and Tolerability		14 days	Yes
Primary	Plasma pharmacokinetics		up to 72 hours post dose	No
Primary	Urine pharmacokinetics		up to 24 hours post dose	No
Primary	Urine Pharmacodynamics		up to 24 hours post dose	No

External Links

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