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

Last updated on May 9, 2018

FOR MORE INFORMATION
Study Location
Pfizer Clinical Research Unit
Brussels, , B-1070 Belgium
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
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 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT02838264
Pfizer
Completed
A Study To Evaluate The Effect Of Itraconazole On Pharmacokinetics Of PF-06463922 In Healthy Volunteers

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A Study To Evaluate The Effect Of Itraconazole On Pharmacokinetics Of PF-06463922 In Healthy Volunteers
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
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.
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.
Interventional
Phase 1
Masking: None (Open Label)
Primary Purpose: Basic Science
Healthy
  • Drug: PF-06463922
    Single oral dose of PF-06463922 50 mg on Day 1 of Period 1 and Day 5 of Period 2
    Other Name: Lorlatinib
  • Drug: PF-06463922
    Single oral dose of PF-06463922 75 mg on Day 1 of Period 1 and Day 5 of Period 2
    Other Name: Lorlatinib
  • Drug: PF-06463922
    Single oral dose of PF-06463922 100 mg on Day 1 of Period 1 and Day 5 of Period 2
    Other Name: Lorlatinib
  • Drug: 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
    Other Name: Lorlatinib
  • Drug: Itraconazole
    200 mg oral dose of itraconazole on Days 1 to 11 during Period 2
    Other Name: Sporanox
  • Experimental: Cohort 1
    All subjects in this cohort will receive the same dose of PF-06463922 in both periods. Subjects will receive PF-06463922 Alone in Period 1 followed by PF-06463922 with Itraconazole in Period 2.
    Interventions:
    • Drug: PF-06463922
    • Drug: Itraconazole
  • Experimental: Cohort 2
    All subjects in this cohort will receive the same dose of PF-06463922 in both periods. Subjects will receive PF-06463922 Alone in Period 1 followed by PF-06463922 with Itraconazole in Period 2.
    Interventions:
    • Drug: PF-06463922
    • Drug: Itraconazole
  • Experimental: Cohort 3
    All subjects in this cohort will receive the same dose of PF-06463922 in both periods. Subjects will receive PF-06463922 Alone in Period 1 followed by PF-06463922 with Itraconazole in Period 2.
    Interventions:
    • Drug: PF-06463922
    • Drug: Itraconazole
  • Experimental: Cohort 4
    All subjects in this cohort will receive the same dose of PF-06463922 in both periods. Subjects will receive the highest safe dose (mg) of PF-06463922 as a single-dose Alone in Period 1 followed by PF-06463922 with Itraconazole in Period 2.
    Interventions:
    • Drug: PF-06463922
    • Drug: Itraconazole
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
May 3, 2017
March 31, 2017   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Belgium
 
 
NCT02838264
B7461012
2016-002386-57 ( EudraCT Number )
ITRACONAZOLE DDI STUDY ( Other Identifier: Alias Study Number )
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
May 2017

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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