A Study To Estimate The Effect Of Ketoconazole On The Pharmacokinetics Of Pf-04937319 In Healthy Subjects

Study Overview
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Brief Summary
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This study will evaluate the potential for a drug-drug interaction of PF-04937319 with ketoconazole, a potent inhibitor of the drug metabolizing enzyme CYP3A.

Official Title
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A Phase I, Open-Label, Fixed Sequence Study To Estimate The Steady-State Effect Of Ketoconazole On The Single-Dose Pharmacokinetics Of PF-04937319 In Healthy Adult Subjects

Conditions
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Human Volunteers

Intervention / Treatment
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* Drug: PF-04937319 / ketoconazole


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male and/or 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 or clinical laboratory tests. Body Mass Index (BMI) of 17.5 to 29.9 kg/m2; and a total body weight >=50 kg (110 lbs). Subjects of childbearing potential must agree to use a highly effective method of contraception throughout the study and for at least 28-days after the last dose of treatment. Exclusion Criteria: Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication. Pregnant or nursing females; females of childbearing potential who are unwilling or unable to use an acceptable method of non-hormonal contraception Consumption of grapefruit-containing products within 7 days prior to the first dose of study medication and while in the study protocol from at least 14 days prior to the first dose of study medication and for at least 28 days after the last dose of study medication

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: PF-04937319 / ketoconazole|Single 20 mg dose of PF-04937319 on day 1, multiple dose of ketoconazole 200 mg twice daily from day 3 to 7, single 20 mg dose of PF-04937319 on day 6|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax of PF-04937319 |  | Day 1 & Day 6 | 
| Tmax of PF-04937319 |  | Day 1 & Day 6 | 
| AUClast of PF-04937319 |  | Day 1 & Day 6 | 
| (as data permits) AUCinf of PF-04937319 |  | Day 1 & Day 6 | 
| (as data permits) t1/2 of PF-04937319 |  | Day 1 & Day 6 | 
| Cmax of PF-04937319 M1 metabolite |  | Day 1 & Day 6 | 
| Tmax of PF-04937319 M1 metabolite |  | Day 1 & Day 6 | 
| AUClast of PF-04937319 M1 metabolite |  | Day 1 & Day 6 | 
| (as data permits) AUCinf of PF-04937319 M1 metabolite |  | Day 1 & Day 6 | 
| (as data permits) t1/2 of PF-04937319 M1 metabolite |  | Day 1 & Day 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinary recovery of PF-04937319 M1 metabolite |  | Day 1 | 
| (as data permits) renal clearance (CLr) of PF-04937319 M1 metabolite |  | Day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Drug Interaction, pharmacokinetics, ketoconazole, CYP3A