Skip to main content
OpenTrials
Completed

NCT Number: NCT01468714

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

New Haven, Connecticut, 06511, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PF-04937319 / ketoconazole

Drug

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

Primary outcomes

  1. Cmax of PF-04937319

    Time frame: Day 1 & Day 6

  2. Tmax of PF-04937319

    Time frame: Day 1 & Day 6

  3. AUClast of PF-04937319

    Time frame: Day 1 & Day 6

  4. (as data permits) AUCinf of PF-04937319

    Time frame: Day 1 & Day 6

  5. (as data permits) t1/2 of PF-04937319

    Time frame: Day 1 & Day 6

  6. Cmax of PF-04937319 M1 metabolite

    Time frame: Day 1 & Day 6

  7. Tmax of PF-04937319 M1 metabolite

    Time frame: Day 1 & Day 6

  8. AUClast of PF-04937319 M1 metabolite

    Time frame: Day 1 & Day 6

  9. (as data permits) AUCinf of PF-04937319 M1 metabolite

    Time frame: Day 1 & Day 6

  10. (as data permits) t1/2 of PF-04937319 M1 metabolite

    Time frame: Day 1 & Day 6

Secondary outcomes

  1. Urinary recovery of PF-04937319 M1 metabolite

    Time frame: Day 1

  2. (as data permits) renal clearance (CLr) of PF-04937319 M1 metabolite

    Time frame: Day 1

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Nov 9, 2011
Registry last updated
Nov 16, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.