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

Last updated on May 9, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
New Haven, Connecticut, 06511 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Human Volunteers
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT01468714
Pfizer
Completed
A Study To Estimate The Effect Of Ketoconazole On The Pharmacokinetics Of Pf-04937319 In Healthy Subjects

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Similar Trials

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
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.
Not Provided
Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Human Volunteers
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
Not Provided
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
October 2011
October 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01468714
B1621011
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2011

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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