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

Human Volunteers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01468714
• Other study ID #: B1621011
• 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

• Human Volunteers

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

External Links

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