NCT01415102

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

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

Interventions

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

Timeline

• Start date: 2010-09-01
• Primary completion: 2010-12-01
• Completion: 2010-12-01
• First posted: 2011-08-11
• Last updated: 2011-08-15

Locations

1 site across 1 country: Belgium