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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01468714
First received: October 4, 2011
Last updated: November 11, 2011
Last verified: November 2011
  Purpose

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 Intervention Phase
Human Volunteers
Drug: PF-04937319 / ketoconazole
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Cmax of PF-04937319 [ Time Frame: Day 1 & Day 6 ] [ Designated as safety issue: No ]
  • Tmax of PF-04937319 [ Time Frame: Day 1 & Day 6 ] [ Designated as safety issue: No ]
  • AUClast of PF-04937319 [ Time Frame: Day 1 & Day 6 ] [ Designated as safety issue: No ]
  • (as data permits) AUCinf of PF-04937319 [ Time Frame: Day 1 & Day 6 ] [ Designated as safety issue: No ]
  • (as data permits) t1/2 of PF-04937319 [ Time Frame: Day 1 & Day 6 ] [ Designated as safety issue: No ]
  • Cmax of PF-04937319 M1 metabolite [ Time Frame: Day 1 & Day 6 ] [ Designated as safety issue: No ]
  • Tmax of PF-04937319 M1 metabolite [ Time Frame: Day 1 & Day 6 ] [ Designated as safety issue: No ]
  • AUClast of PF-04937319 M1 metabolite [ Time Frame: Day 1 & Day 6 ] [ Designated as safety issue: No ]
  • (as data permits) AUCinf of PF-04937319 M1 metabolite [ Time Frame: Day 1 & Day 6 ] [ Designated as safety issue: No ]
  • (as data permits) t1/2 of PF-04937319 M1 metabolite [ Time Frame: Day 1 & Day 6 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Urinary recovery of PF-04937319 M1 metabolite [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • (as data permits) renal clearance (CLr) of PF-04937319 M1 metabolite [ Time Frame: Day 1 ] [ Designated as safety issue: No ]

Enrollment: 10
Study Start Date: October 2011
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    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
  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01468714

Locations
United States, Connecticut
Pfizer Investigational Site
New Haven, Connecticut, United States, 06511
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01468714     History of Changes
Other Study ID Numbers: B1621011
Study First Received: October 4, 2011
Last Updated: November 11, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Drug Interaction
pharmacokinetics
ketoconazole
CYP3A

Additional relevant MeSH terms:
Ketoconazole
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 19, 2014