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Clinical Trials/NCT00990756
NCT00990756
Completed
Phase 1

A Double Blind (3rd Party Open), Randomised, Placebo Controlled, Dose Escalation Study To Investigate The Safety, Toleration, And Pharmacokinetics Of Multiple Inhaled Doses Of PF-03526299 In Healthy Male Subjects

Pfizer1 site in 1 country24 target enrollmentNovember 2009
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ConditionsHealthy
InterventionsPF-03526299
DrugsPF-03526299

Overview

Phase
Phase 1
Intervention
PF-03526299
Conditions
Healthy
Sponsor
Pfizer
Enrollment
24
Locations
1
Primary Endpoint
Safety/toleration: Adverse events, vital signs, 12 lead ECG, blood and urine safety tests and physical examination.
Status
Completed
Last Updated
16 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 2009
End Date
January 2010
Last Updated
16 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Pfizer

Eligibility Criteria

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.

Arms & Interventions

PF-03526299 1.396 mg

Intervention: PF-03526299

PF-03526299 4mg

Intervention: PF-03526299

Outcomes

Primary Outcomes

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

Time Frame: 17 days

Secondary Outcomes

  • 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)

Study Sites (1)

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