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A Pharmacokinetic Study of Three Different Particle Sizes of PH-797804

Pfizer logo

Pfizer

Status and phase

Withdrawn
Phase 1

Conditions

Healthy

Treatments

Drug: PH-797804

Study type

Interventional

Funder types

Industry

Identifiers

NCT01924650
A6631040

Details and patient eligibility

About

The purpose of this study is to investigate the effects of varying particle size on the pharmacokinetics of PH-797804

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Healthy male subjects and/or healthy female subjects of non-child bearing potential between the ages of 18 and 55 years (inclusive). Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurements, 12-lead ECG and clinical laboratory tests.
  • Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight > 50 kg (110 lbs).

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 14 drinks/week for males.

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

0 participants in 6 patient groups

PH-797804 PARTICLE SIZE 9-11UM
Experimental group
Treatment:
Drug: PH-797804
Drug: PH-797804
Drug: PH-797804
Drug: PH-797804
Drug: PH-797804
Drug: PH-797804
PH-797804 PARTICLE SIZE 9-11UM WITH SLS
Experimental group
Treatment:
Drug: PH-797804
Drug: PH-797804
Drug: PH-797804
Drug: PH-797804
Drug: PH-797804
Drug: PH-797804
PH-797804 PARTICLE SIZE <= 20UM
Experimental group
Treatment:
Drug: PH-797804
Drug: PH-797804
Drug: PH-797804
Drug: PH-797804
Drug: PH-797804
Drug: PH-797804
PH-797804 PARTICLE SIZE <= 20UM WITH SLS
Experimental group
Treatment:
Drug: PH-797804
Drug: PH-797804
Drug: PH-797804
Drug: PH-797804
Drug: PH-797804
Drug: PH-797804
PH-797804 PARTICLE SIZE <= 5UM
Experimental group
Treatment:
Drug: PH-797804
Drug: PH-797804
Drug: PH-797804
Drug: PH-797804
Drug: PH-797804
Drug: PH-797804
PH-797804 PARTICLE SIZE <= 5UM WITH SLS
Experimental group
Treatment:
Drug: PH-797804
Drug: PH-797804
Drug: PH-797804
Drug: PH-797804
Drug: PH-797804
Drug: PH-797804

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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