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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01468714

Enrollment

Registered

2011-11-09

Start date

2011-10-31

Completion date

2011-10-31

Last updated

2011-11-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Human Volunteers

Keywords

Drug Interaction, pharmacokinetics, ketoconazole, CYP3A

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.

Interventions

DRUGPF-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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

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

Design outcomes

Primary

Measure	Time frame
(as data permits) t1/2 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
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

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026