Food Effect Study PF-04136309

Sponsor

Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT02598206

Collaborator

(none)

Enrollment

Location

Arm

Actual Duration (Months)

3.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the effect of food intake on PF-04136309 pharmacokinetics (PK) following a single dose at 1000 mg.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: PF-04136309	Phase 1

Detailed Description

The present study will be conducted in healthy adult subjects. The single dose of 1000 mg has been shown to be safe in a previous study in healthy subjects. To evaluate the effect of food on PF-04136309 PK at the dose of 1000 mg, which is the maximum dose that may be evaluated in the multiple dose setting in patients, will provide information to guide the dose administration in regards to food intake at relevant therapeutic dose levels for further studies in patients.

Study Design

Study Type:

Interventional

Actual Enrollment :

18 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

A Phase 1, Randomized, Open Label, Single Dose, 2-period Crossover Study To Evaluate Food Effect On The Pharmacokinetics Of Pf-04136309 In Healthy Subjects

Actual Study Start Date :

Dec 1, 2015

Actual Primary Completion Date :

May 1, 2016

Actual Study Completion Date :

May 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental 1 All subjects will receive 2 treatments in one of the indicated sequence orders: A - B B - A	Drug: PF-04136309 Treatment A (n=18): a single dose of 1000 mg PF 04136309 will be administered in a fasted state as 8 × 125 mg Tablets. Treatment B (n=18): a single dose of 1000 mg PF-04136309 will be administered with a high fat breakfast as 8 × 125 mg Tablets.

Arm

Intervention/Treatment

Experimental: Experimental 1

All subjects will receive 2 treatments in one of the indicated sequence orders: A - B B - A

Drug: PF-04136309

Treatment A (n=18): a single dose of 1000 mg PF 04136309 will be administered in a fasted state as 8 × 125 mg Tablets. Treatment B (n=18): a single dose of 1000 mg PF-04136309 will be administered with a high fat breakfast as 8 × 125 mg Tablets.

Outcome Measures

Primary Outcome Measures

Area Under the Curve from time Zero to Extrapolated Infinite Time (AUC[0-inf]). [0(pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours (hrs) post-PF-04136309 dose]
AUC(0-inf)=Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (o-inf). It is obtained from AUC (0-t) plus AUC (t-inf).
Maximum Plasma Concentration [Cmax] [0(pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hrs post PF-04136309 dose]

Secondary Outcome Measures

Area Under the Curve from Time Zero to Last Quantifiable Concentration (AUClast) [0(pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hrs post PF-04136309]
Area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration (AUClast).
Time to Reach maximum Observed Plasma Concentration (Tmax) [0(pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hrs post PF-04136309 dose]
Time for Cmax
Plasma Decay Half Life (t1/2) [0(pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hrs post PF-04136309]
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Apparent Oral Clearance (CL/F) [0(pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hrs post-PF-04136309 dose]
Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the body. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed.
Apparent Volume of Distribution (Vz/F) [0(pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hrs post PF-04136309 dose]
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Healthy female subjects of non childbearing potential, who at the time of screening are between the ages of 45 55, and/or male subjects between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG and clinical laboratory tests).
Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).

Exclusion Criteria:

Subjects who are smoking, or with evidence of disease, conditions affecting absorption, treatment with other investigational drug within 30 days, history of regular alcohol consumption, use of prescription, nonprescription drugs and dietary supplement within 7 days, or blood donation of 500 mL within 56 days

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:

NCT02598206

Other Study ID Numbers:

A9421019
2015-003649-24

First Posted:

Nov 5, 2015

Last Update Posted:

Apr 11, 2018

Last Verified:

Apr 1, 2018

Keywords provided by Pfizer

Study Results

No Results Posted as of Apr 11, 2018