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

Sponsor

Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT01468714

Collaborator

(none)

Enrollment

Location

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Human Volunteers	Drug: PF-04937319 / ketoconazole	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

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

Study Start Date :

Oct 1, 2011

Actual Primary Completion Date :

Oct 1, 2011

Actual Study Completion Date :

Oct 1, 2011

Outcome Measures

Primary Outcome Measures

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

Urinary recovery of PF-04937319 M1 metabolite [Day 1]
(as data permits) renal clearance (CLr) of PF-04937319 M1 metabolite [Day 1]

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 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