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

NCT01468714 | Completed Phase 1

• 1 other identifier: B1621011
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Human Volunteers

Keywords

Drug Interaction; pharmacokinetics; ketoconazole; CYP3A

Outcome Measures

Primary Outcomes (10)

• 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 Outcomes (2)

• Urinary recovery of PF-04937319 M1 metabolite

  Day 1

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

  Day 1

Interventions

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

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Investigational Site

New Haven, Connecticut, 06511, United States

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Interventions

N,N-dimethyl-5-((2-methyl-6-((5-methylpyrazin-2-yl)carbamoyl)benzofuran-4-yl)oxy)pyrimidine-2-carboxamide; Ketoconazole

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2011
• First Posted: November 9, 2011
• Study Start: October 1, 2011
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: November 16, 2011

Record last verified: 2011-11

Locations

US (1)