Food Effect Study for PF-06372865

Healthy Clinical Trial

Official title:

A Phase 1, Cross-over, Randomized, Single-dose Open Label Study To Determine The Effect Of Food On The Pharmacokinetics Of Orally Administered Pf-06372865 In Healthy Adult Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02217787
• Other study ID #: B7431008
• Secondary ID: 2014-002967-13
• Status: Completed
• Phase: Phase 1
• First received: August 7, 2014
• Last updated: October 24, 2014
• Start date: September 2014
• Est. completion date: September 2014

Study information

• Verified date: October 2014
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• PF-06372865
7.5 mg as 3 x 2.5 mg tablets single dose
• PF-06372865
7.5 mg as 3 x 2.5 mg tablets single dose

Locations

Country	Name	City	State
Belgium	Pfizer Clinical Research Unit	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	Maximum Observed Plasma Concentration (Cmax)		basline to 48 hours	No
Primary	Time to Reach Maximum Observed Plasma Concentration (Tmax)		basline to 48 hours	No
Primary	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	No
Secondary	Change from Baseline in Systolic Blood Pressure	Value at time T minus value at baseline.	basline to 48 hours	No
Secondary	Change from Baseline in Diastolic Blood Pressure	Value at time T minus value at baseline.	basline to 48 hours	No
Secondary	Change from baseline in heart rate	value at time T minus value at baseline	basline to 48 hours	No

External Links

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