Food Effect Study for PF-06372865

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02217787
• Collaborator: (none)
• Enrollment: 12
• Location: 1
• Arms: 2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: PF-06372865; Drug: PF-06372865	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 12 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• 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
• Study Start Date: Sep 1, 2014
• Actual Primary Completion Date: Sep 1, 2014
• Actual Study Completion Date: Sep 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Other: fasted condition	Drug: PF-06372865; 7.5 mg as 3 x 2.5 mg tablets single dose
Other: fed condition	Drug: PF-06372865; 7.5 mg as 3 x 2.5 mg tablets single dose

Outcome Measures

Primary Outcome Measures

1. 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).

2. 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)

3. Maximum Observed Plasma Concentration (Cmax) [basline to 48 hours]

4. Time to Reach Maximum Observed Plasma Concentration (Tmax) [basline to 48 hours]

5. 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

1. Change from Baseline in Systolic Blood Pressure [basline to 48 hours]

   Value at time T minus value at baseline.

2. Change from Baseline in Diastolic Blood Pressure [basline to 48 hours]

   Value at time T minus value at baseline.

3. Change from baseline in heart rate [basline to 48 hours]

   value at time T minus value at baseline

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Clinical Research Unit	Brussels		Belgium	B-1070

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

None provided.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT02217787
• Other Study ID Numbers: B7431008; 2014-002967-13
• First Posted: Aug 15, 2014
• Last Update Posted: Oct 27, 2014
• Last Verified: Oct 1, 2014

• Additional relevant MeSH terms: PF-06372865

Study Results

No Results Posted as of Oct 27, 2014