Multiple Dose Healthy Volunteer Study of PF-03715455.

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: PF-03715455; Drug: Placebo

• Registration Number: NCT01186757
• Lead Sponsor: Pfizer

Brief Summary

Evaluation of the multiple dose pharmacokinetics of PF-3715455 in healthy volunteers

Detailed Description

Healthy volunteer PK study

Study Timeline

• Study Start: 2010-08
• Study First Submitted: 2010-08-11
• Study First Submitted QC: 2010-08-20
• Study First Posted: 2010-08-23
• Status Verified: 2011-01
• Primary Completion: 2011-01
• Study Completion: 2011-01
• Last Update Submitted: 2011-01-11
• Last Update Posted: 2011-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• Healthy volunteers

Exclusion Criteria

• Standard healthy volunteer criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PF-03715455 10 mg BID	PF-03715455	-
Placebo	Placebo	-
PF-03715455 1.6mg BID	PF-03715455	-
PF-03715455 4 mg BID	PF-03715455	-

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics of single and multiple inhaled doses of PF-03715455, as measured by plasma concentrations - Cmax, Tmax, AUCtau, t½, accumulation ratio (Rac, Rss, Rac,Cmax).	17 days

Secondary Outcome Measures

Name	Time	Method
Safety and toleration as measured by adverse events, vital signs, 12 lead ECG, blood and urine safety tests and physical examination.	28 Days

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇸🇬 Singapore, Singapore