Food Effect Study for PF-06372865

NCT02217787 | Completed Phase 1

• 2 other identifiers: B74310082014-002967-13
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (5)

• Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]

  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).

  basline to 48 hours

• Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)

  Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)

  basline to 48 hours

• Maximum Observed Plasma Concentration (Cmax)

  basline to 48 hours

• Time to Reach Maximum Observed Plasma Concentration (Tmax)

  basline to 48 hours

• Plasma Decay Half-Life (t1/2)

  Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

  basline to 48 hours

Secondary Outcomes (3)

• Change from Baseline in Systolic Blood Pressure

  basline to 48 hours

• Change from Baseline in Diastolic Blood Pressure

  basline to 48 hours

• Change from baseline in heart rate

  basline to 48 hours

Study Arms (2)

fasted condition

OTHER

Drug: PF-06372865

fed condition

OTHER

Drug: PF-06372865

Interventions

PF-06372865 DRUG

7.5 mg as 3 x 2.5 mg tablets single dose

fasted condition

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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);

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Clinical Research Unit

Brussels, B-1070, Belgium

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Interventions

PF-06372865

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2014
• First Posted: August 15, 2014
• Study Start: September 1, 2014
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: October 27, 2014

Record last verified: 2014-10

Locations

BE (1)