Clinical trial NCT01468714: A Study To Estimate The Effect Of Ketoconazole On The Pharmacokinetics Of Pf-04937319 In Healthy Subjects
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Human Volunteers
Keywords: Drug Interaction
pharmacokinetics
ketoconazole
CYP3A
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-11-09
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Cmax of PF-04937319
timeFrame: Day 1 & Day 6
measure: Tmax of PF-04937319
timeFrame: Day 1 & Day 6
measure: AUClast of PF-04937319
timeFrame: Day 1 & Day 6
measure: (as data permits) AUCinf of PF-04937319
timeFrame: Day 1 & Day 6
measure: (as data permits) t1/2 of PF-04937319
timeFrame: Day 1 & Day 6
measure: Cmax of PF-04937319 M1 metabolite
timeFrame: Day 1 & Day 6
measure: Tmax of PF-04937319 M1 metabolite
timeFrame: Day 1 & Day 6
measure: AUClast of PF-04937319 M1 metabolite
timeFrame: Day 1 & Day 6
measure: (as data permits) AUCinf of PF-04937319 M1 metabolite
timeFrame: Day 1 & Day 6
measure: (as data permits) t1/2 of PF-04937319 M1 metabolite
timeFrame: Day 1 & Day 6
Secondary outcomes:
measure: Urinary recovery of PF-04937319 M1 metabolite
timeFrame: Day 1
measure: (as data permits) renal clearance (CLr) of PF-04937319 M1 metabolite
timeFrame: Day 1
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Pfizer Investigational Site
state: Connecticut
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: