A Phase 1 Study To Evaluate The Safety And Tolerability Of Different Doses Of PF-03526299 In Healthy Adult Volunteers

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: PF-03526299

• Registration Number: NCT00990756
• Lead Sponsor: Pfizer

Brief Summary

The purpose of this study is to investigate safety and toleration of multiple inhaled doses as well as the time course of PF-03526299 concentration in the blood following dosing by dry powder inhaler.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-10-05
• Study First Submitted QC: 2009-10-05
• Study First Posted: 2009-10-07
• Study Start: 2009-11
• Status Verified: 2010-01
• Primary Completion: 2010-01
• Study Completion: 2010-01
• Last Update Submitted: 2010-01-21
• Last Update Posted: 2010-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Healthy male subjects and females of non-childbearing potential between the ages of 21 and 55 years.
• Body Mass Index (BMI) of 17.5 to 30.5 kg/m^2; and a total body weight >50 kg (110 lbs).
• Subjects who had a normal chest X-ray in the previous 6 months prior to Screening

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.
• History of regular alcohol consumption exceeding 21 drinks/week for males and 14 drinks/week for females.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PF-03526299 1.396 mg	PF-03526299	-
PF-03526299 4mg	PF-03526299	-

Primary Outcome Measures

Name	Time	Method
Safety/toleration: Adverse events, vital signs, 12 lead ECG, blood and urine safety tests and physical examination.	17 days

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetic parameters: Plasma Day 1: Cmax, Tmax, AUCτau.	Day 1 - 17
Plasma Day 7: Cmax, Tmax.	7 Days
Plasma Day 14: Cmax, Tmax, CL/F, AUCτau, t½, accumulation ratio, time to steady state.	14 Days

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇸🇬 Singapore, Singapore