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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01468714
Other study ID # B1621011
Secondary ID
Status Completed
Phase Phase 1
First received October 4, 2011
Last updated November 11, 2011
Start date October 2011
Est. completion date October 2011

Study information

Verified date November 2011
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date October 2011
Est. primary completion date October 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 55 Years
Eligibility 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

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Pfizer Investigational Site New Haven Connecticut

Sponsors (1)

Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Cmax of PF-04937319 Day 1 & Day 6 No
Primary Tmax of PF-04937319 Day 1 & Day 6 No
Primary AUClast of PF-04937319 Day 1 & Day 6 No
Primary (as data permits) AUCinf of PF-04937319 Day 1 & Day 6 No
Primary (as data permits) t1/2 of PF-04937319 Day 1 & Day 6 No
Primary Cmax of PF-04937319 M1 metabolite Day 1 & Day 6 No
Primary Tmax of PF-04937319 M1 metabolite Day 1 & Day 6 No
Primary AUClast of PF-04937319 M1 metabolite Day 1 & Day 6 No
Primary (as data permits) AUCinf of PF-04937319 M1 metabolite Day 1 & Day 6 No
Primary (as data permits) t1/2 of PF-04937319 M1 metabolite Day 1 & Day 6 No
Secondary Urinary recovery of PF-04937319 M1 metabolite Day 1 No
Secondary (as data permits) renal clearance (CLr) of PF-04937319 M1 metabolite Day 1 No
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