A Study To Evaluate The Effect Of Itraconazole On Pharmacokinetics Of PF-06463922 In Healthy Volunteers

Healthy Clinical Trial

Official title:

Phase 1, Open-label, Fixed Sequence, 2-period Study To Investigate The Effect Of Multiple Doses Of Itraconazole On The Pharmacokinetics Of Single Dose Pf-06463922 In Healthy Volunteers In The Fasted Condition

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02838264
• Other study ID #: B7461012
• Secondary ID: 2016-002386-57IT
• Status: Completed
• Phase: Phase 1
• First received: July 17, 2016
• Last updated: May 12, 2017
• Start date: August 16, 2016
• Est. completion date: May 3, 2017

Study information

• Verified date: May 2017
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to estimate the effect of itraconazole on the single dose pharmacokinetics of PF-06463922 in healthy volunteers in the fasted state.

Description:

This will be a Phase 1, open-label, 2-period, fixed-sequence, crossover study to investigate the effect of the strong CYP3A inhibitor itraconazole on PF-06463922 PK in approximately 16 healthy volunteers. The study will consist of potentially up to 6 treatments: single dose of PF-06463922 50, 75 or 100 mg and PF-06463922 50, 75 or 100 mg in combination with multiple dose itraconazole.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: May 3, 2017
• Est. primary completion date: March 31, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Healthy female subjects of non childbearing potential and/or male subjects, who at the time of screening, are between the ages of 18 and 55 years, inclusive.

• Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).

Exclusion Criteria:

• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).

• Any condition possibly affecting drug absorption.

• A positive urine drug test.

• History of HIV, Hep B or Hep C.

• History of regular alcohol consumption.

• Screening supine 12 lead ECG demonstrating PR interval >180 msec, QTc >450 msec or a QRS interval >120 msec.

• Subjects with ANY of the following abnormalities in clinical laboratory tests at screening, as assessed by the study-specific laboratory and confirmed by a single repeat, if deemed necessary: Use this criterion to describe any laboratory parameters that are not acceptable for the study. Examples included below:

• Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level >1.0 × upper limit of normal (ULN);

• Total bilirubin level >1.0 × ULN; subjects with a history of Gilbert's syndrome may have direct bilirubin measured and would be eligible for this study provided the direct bilirubin level is <= ULN.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• PF-06463922
Single oral dose of PF-06463922 50 mg on Day 1 of Period 1 and Day 5 of Period 2
• PF-06463922
Single oral dose of PF-06463922 75 mg on Day 1 of Period 1 and Day 5 of Period 2
• PF-06463922
Single oral dose of PF-06463922 100 mg on Day 1 of Period 1 and Day 5 of Period 2
• PF-06463922
Highest safe single oral dose (mg) of PF-06463922 identified in the previous cohorts will be administered on Day 1 of Period 1 and Day 5 of Period 2
• Itraconazole
200 mg oral dose of itraconazole on Days 1 to 11 during Period 2

Locations

Country	Name	City	State
Belgium	Pfizer Clinical Research Unit	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUCinf for PF-06463922	Area under the plasma concentration-time profile from time zero extrapolated to infinite time	PF-06463922 pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and up to 168 hours post-dose.
Primary	Cmax for PF-06463922	Maximum plasma concentration	PF-06463922 pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and up to 168 hours post-dose.
Secondary	AUClast for PF-06463922	Area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration (Clast)	PF-06463922 pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and up to 168 hours post-dose.
Secondary	Tmax for PF-06463922	Time to Cmax	PF-06463922 pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and upto 168 hours post-dose.
Secondary	t1/2 for PF-06463922	Terminal plasma elimination half-life	PF-06463922 pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and up to 168 hours post-dose.
Secondary	CL/F for PF-06463922	Apparent clearance	PF-06463922 pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and up to 168 hours post-dose.
Secondary	Vz/F for PF-06463922	Apparent volume of distribution	PF-06463922 pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and up to 168 hours post-dose.
Secondary	AUCinf for any potential PF-06463922 metabolite if necessary	Area under the plasma concentration-time profile from time zero extrapolated to infinite time	PF-06463922 pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and up to 168 hours post-dose.
Secondary	AUClast for any potential PF-06463922 metabolite if necessary	Area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration (Clast)	PF-06463922 pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and up to 168 hours post-dose.
Secondary	Cmax for any potential PF-06463922 metabolite if appropriate	Maximum plasma concentration	PF-06463922 pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and up to 168 hours post-dose.
Secondary	Tmax for any potential PF-06463922 metabolite if appropriate	Time to Cmax	PF-06463922 pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and up to 168 hours post-dose.
Secondary	t1/2 for any potential metabolite of PF-06463922 if appropriate	Terminal plasma elimination half-life	PF-06463922 pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and up to 168 hours post-dose.
Secondary	MRCmax for any potential PF-06463922 metabolite if appropriate	metabolite to parent ratio for Cmax	PF-06463922 pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and up to 168 hours post-dose.
Secondary	MRAUClast for any potential PF-06463922 metabolite if appropriate	metabolite to parent ratio for AUClast	PF-06463922 pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and up to 168 hours post-dose.
Secondary	MRAUCinf for any potential PF-06463922 metabolite if appropriate	metabolite to parent ratio for AUCinf	PF-06463922 pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and up to 168 hours post-dose.
Secondary	PR interval after PF-06463922 alone and after increased exposure of PF 06463922 (due to concomitant itraconzole administration).	Change in PR interval from baseline after administration of PF-06463922 single dose as assessed by ECG.	Within 24 hours after single dose administration of PF-06463922 alone and in combination with itraconazole.

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