Study To Determine The Effect Of Food And Strong CYP3A4 Enzyme Inhibitor On PF-04449913 Drug Levels

Sponsor

Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT01749085

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

6.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The study aims to determine what effect a high fat meal will have on the drug exposure of PF-04449913. The study also aims to determine the effect of a strong enzyme (CYP3A4) inhibitor on drug exposure of PF-04449913.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Drug: PF-04449913, ketoconazole Drug: PF-04449913, ketoconazole	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

14 participants

Allocation:

Non-Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

A Phase 1, Open Label Study In Healthy Subjects To Estimate The Effect Of Food And The Drug-Drug Interaction Potential Of Ketoconazole On PF-04449913 Pharmacokinetics

Study Start Date :

Dec 1, 2012

Actual Primary Completion Date :

Feb 1, 2013

Actual Study Completion Date :

Feb 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Sequence 1	Drug: PF-04449913, ketoconazole Subjects receive a 200 mg oral dose of PF-04449913 under fasted conditions with washout, then single 200 mg oral dose of PF-04449913 under fed with washout and finally a single 200 mg dose 0f PF-04449913 following dosing to steady state with ketoconazole
Experimental: Sequence 2	Drug: PF-04449913, ketoconazole Subjects receive a 200 mg oral dose of PF-04449913 under fed conditions with washout, then single 200 mg oral dose of PF-04449913 under fasted with washout and finally a single 200 mg dose of PF-04449913 following dosing to steady state with ketoconazole

Arm

Intervention/Treatment

Experimental: Sequence 1

Drug: PF-04449913, ketoconazole

Subjects receive a 200 mg oral dose of PF-04449913 under fasted conditions with washout, then single 200 mg oral dose of PF-04449913 under fed with washout and finally a single 200 mg dose 0f PF-04449913 following dosing to steady state with ketoconazole

Experimental: Sequence 2

Drug: PF-04449913, ketoconazole

Subjects receive a 200 mg oral dose of PF-04449913 under fed conditions with washout, then single 200 mg oral dose of PF-04449913 under fasted with washout and finally a single 200 mg dose of PF-04449913 following dosing to steady state with ketoconazole

Outcome Measures

Primary Outcome Measures

Maximum Observed Plasma Concentration (Cmax) [8 days]
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)] [8 days]

Secondary Outcome Measures

Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) [8 days]
Apparent Oral Clearance (CL/F) [8 days]
Time to Reach Maximum Observed Plasma Concentration (Tmax) [8 days]
Apparent Volume of Distribution (Vz/F) [8 days]
Plasma Decay Half-Life (t1/2) [8 days]

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 female 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).
An informed consent document signed and dated by the subject.
Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion Criteria:

Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
A positive urine drug screen
12-lead ECG demonstrating QTc >450 msec or a QRS interval >120 msec at Screening. If QTc exceeds 450 msec, or QRS exceeds 120 msec, the ECG should be repeated two more times and the average of the three QTc values should be used to determine the subject's eligibility. Subjects with one of the following currently in the past 6 months: myocardial infarction, congenital long QT syndrome, torsades de pointes or clinically significant ventricular arrhythmias.
Pregnant or nursing females and females of childbearing potential including those with tubal ligation. To be considered for enrollment, women of 45 to 55 years of age who are postmenopausal (defined as being amenorrheic for at least 2 years) must have confirmatory FSH test results at Screening.