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A Study to Estimate the Effect of CYP3A4 Inhibitors (Itraconazole, Diltiazem or Verapamil) on the Pharmacokinetics of Single Dose PF- 00489791 in Healthy Volunteers

Last updated on November 13, 2019

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 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 and clinical laboratory tests) with a Body Mass Index (BMI)
of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs.) and with a
personally signed and dated informed consent document and who are willing and able to
comply with scheduled visits, treatment plan, laboratory tests, and other study
procedures.

- Participating female subjects of non-childbearing potential must meet at least one of
the following criteria: achieved postmenopausal status; have undergone a documented
hysterectomy and/or bilateral oophorectomy; have medically confirmed ovarian failure.
All other female subjects (including females with tubal ligations and females that do
NOT have a documented hysterectomy, bilateral oophorectomy and/or ovarian failure)
will be considered to be of childbearing potential.

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

- Subjects cannot be included in the study if there is: the presence/ history of any
disorder that prevents study completion

- Evidence/history of clinically significant hematological, renal, endocrine,
pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or
allergic disease

- Any surgical or medical condition that may interfere with the absorption
distribution, metabolism, or excretion of the study drug

- A positive urine drug screen or history of regular excessive alcohol consumption or
use of tobacco-or nicotine-containing products in excess or from 24-hours prior to
admission until discharge

- Treatment with an investigational drug within 30 days (or as determined by the local
requirement) or 5 halflives preceding the first dose of study med.

- Out of range blood pressure including current evidence of orthostatic change in blood
pressure

- Abnormal ECG or history or current evidence of clinically important cardiac
conduction abnormalities.

- Also excluded are: pregnant or breastfeeding female subjects; male subjects with
partners currently pregnant; male and female subjects of childbearing potential who
are unwilling or unable to use a highly effective method of contraception as
described in the protocol for the duration of the study and for at least 28 days
after the last dose of investigational product.

NCT02319148
Pfizer
Completed
A Study to Estimate the Effect of CYP3A4 Inhibitors (Itraconazole, Diltiazem or Verapamil) on the Pharmacokinetics of Single Dose PF- 00489791 in Healthy Volunteers

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[email protected]

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Descriptive Information
Brief Title  ICMJE A Study to Estimate the Effect of CYP3A4 Inhibitors (Itraconazole, Diltiazem or Verapamil) on the Pharmacokinetics of Single Dose PF- 00489791 in Healthy Volunteers
Official Title  ICMJE A Phase 1, Randomized, Open-label, 3-sequence, 4-treatment, Incomplete Block Design To Estimate The Effect Of Steady State Cyp3a4 Inhibitors (Itraconazole, Diltiazem Or Verapamil) On The Pharmacokinetics Of Singe Dose Pf-00489791 In Healthy Volunteers
Brief SummaryThe primary objective of the study is to estimate the effects of different strong enzyme (CYP3A4) inhibitors, itraconazole, diltiazem, or verapamil on the single dose pharmacokinetics of PF-00489791 in healthy volunteers. The study will enroll approximately 18 subjects that are randomized to 1 of 3 treatment groups. The study is also intended to determine the safety and tolerability of single-dose PF- 00489791 when it is administered with steady-state itraconazole, diltiazem, or verapamil.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Healthy Volunteers
Intervention  ICMJE
  • Drug: itraconazole
    itraconazole dosed at 200 mg
  • Drug: diltiazem
    diltiazem dosed at 240 mg
  • Drug: SR verapamil
    SR verapamil dosed at 240 mg
  • Drug: PF-00489791
    PF-00489791 20 mg single dose administration
Study Arms  ICMJE
  • Experimental: Treatment B
    Treatment B subjects receive single dose administration of 20 mg PF-00489791 and multiple dose administration of itraconazole (200 mg once daily).
    Interventions:
    • Drug: itraconazole
    • Drug: PF-00489791
  • Experimental: Treatment C
    Treatment C subjects receive single dose administration of 20 mg PF-00489791 and multiple dose administration of diltiazem (240 mg once daily).
    Interventions:
    • Drug: diltiazem
    • Drug: PF-00489791
  • Experimental: Treatment D
    Treatment D subjects receive single dose administration of 20 mg PF-00489791 and multiple dose administration of verapamil (240 mg once daily).
    Interventions:
    • Drug: SR verapamil
    • Drug: PF-00489791
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 12, 2014)
22
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2014
Actual Primary Completion DateOctober 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 and clinical laboratory tests) with a Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs.) and with a personally signed and dated informed consent document and who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
  • Participating female subjects of non-childbearing potential must meet at least one of the following criteria: achieved postmenopausal status; have undergone a documented hysterectomy and/or bilateral oophorectomy; have medically confirmed ovarian failure. All other female subjects (including females with tubal ligations and females that do NOT have a documented hysterectomy, bilateral oophorectomy and/or ovarian failure) will be considered to be of childbearing potential.

Exclusion Criteria:

  • Subjects cannot be included in the study if there is: the presence/ history of any disorder that prevents study completion
  • Evidence/history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease
  • Any surgical or medical condition that may interfere with the absorption distribution, metabolism, or excretion of the study drug
  • A positive urine drug screen or history of regular excessive alcohol consumption or use of tobacco-or nicotine-containing products in excess or from 24-hours prior to admission until discharge
  • Treatment with an investigational drug within 30 days (or as determined by the local requirement) or 5 halflives preceding the first dose of study med.
  • Out of range blood pressure including current evidence of orthostatic change in blood pressure
  • Abnormal ECG or history or current evidence of clinically important cardiac conduction abnormalities.
  • Also excluded are: pregnant or breastfeeding female subjects; male subjects with partners currently pregnant; male and female subjects of childbearing potential who are unwilling or unable to use a highly effective method of contraception as described in the protocol for the duration of the study and for at least 28 days after the last dose of investigational product.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02319148
Other Study ID Numbers  ICMJE A7331022
2014-001979-31 ( EudraCT Number )
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateJuly 2016

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 the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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