Food Effect Study for PF-06372865

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: PF-06372865

• Registration Number: NCT02217787
• Lead Sponsor: Pfizer

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-08-07
• Study First Submitted QC: 2014-08-13
• Study First Posted: 2014-08-15
• Study Start: 2014-09
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-24
• Last Update Posted: 2014-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
fasted condition	PF-06372865	-
fed condition	PF-06372865	-

Primary Outcome Measures

Name	Time	Method
Maximum Observed Plasma Concentration (Cmax)	basline to 48 hours
Time to Reach Maximum Observed Plasma Concentration (Tmax)	basline to 48 hours
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]	basline to 48 hours	AUC (0 - 8)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - 8). It is obtained from AUC (0 - t) plus AUC (t - 8).
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)	basline to 48 hours	Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
Plasma Decay Half-Life (t1/2)	basline to 48 hours	Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

Secondary Outcome Measures

Name	Time	Method
Change from Baseline in Systolic Blood Pressure	basline to 48 hours	Value at time T minus value at baseline.
Change from Baseline in Diastolic Blood Pressure	basline to 48 hours	Value at time T minus value at baseline.
Change from baseline in heart rate	basline to 48 hours	value at time T minus value at baseline

Trial Locations

Locations (1)

Pfizer Clinical Research Unit; 🇧🇪 Brussels, Belgium