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Food Effect Study for PF-06372865

Pfizer logo

Pfizer

Status and phase

Completed
Phase 1

Conditions

Healthy

Treatments

Drug: PF-06372865

Study type

Interventional

Funder types

Industry

Identifiers

NCT02217787
B7431008
2014-002967-13 (EudraCT Number)

Details and patient eligibility

About

This study has been designed to investigate the effect of high fat food on the pharmacokinetics of PF-06372865 when administered to healthy subjects as single oral doses.

Enrollment

12 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Healthy male and/or female subjects of non-childbearing potential between the ages of 18 and 55 years, inclusive
  • 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
  • Screening supine blood pressure > 140 mm Hg (systolic) or >90 mm Hg (diastolic), following at least 5 minutes of supine rest.
  • Any condition possibly affecting drug absorption: current or recent (within one year) gastrointestinal disease; a history of malabsorption, esophageal reflux, irritable bowel syndrome; frequent (more than once a week) occurrence of heartburn; or any surgical intervention (e.g., cholecysectomy) which would be expected to influence the absorption of drugs.

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

12 participants in 2 patient groups

fasted condition
Other group
Treatment:
Drug: PF-06372865
Drug: PF-06372865
fed condition
Other group
Treatment:
Drug: PF-06372865
Drug: PF-06372865

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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