A Study to Investigate the Effect of Multiple Doses of Itraconazole on the Pharmacokinetics of PF-06700841 in Healthy Participants

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NCT04090047

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Study Location
Pfizer New Haven Clinical Research Unit
New Haven, Connecticut, 06511, United States
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Contact
1-800-718-1021
[email protected]
Related Links

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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[email protected]

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Heathy Participants
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

- Male and female participants who are overtly healthy as determined by medical evaluation including a detailed medical history, full physical examination, which includes blood pressure (BP) and pulse rate measurement, clinical laboratory tests, and 12-lead ECG.

- Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb).

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, neurological, or
allergic disease (including drug allergies, but excluding untreated, asymptomatic,
seasonal allergies at the time of dosing).


- Evidence or history of clinically significant dermatological condition (eg, contact
dermatitis or psoriasis) or visible rash present during physical examination.


- Participant with a history of known hypersensitivity to itraconazole or its excipients
or to other azole antifungals.


- History of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C;
positive testing for HIV, hepatitis B core antibody (HBcAb), hepatitis B surface
antigen (HBsAg), or hepatitis C antibody (HCVAb). Hepatitis B vaccination is allowed.


- History of tuberculosis or active or latent or inadequately treated infection,
positive QuantiFERON®- tuberculosis (TB) Gold or equivalent test.


- Have a history of any lymphoproliferative disorder (such as Epstein Barr Virus [EBV]
related lymphoproliferative disorder, as reported in some participants on other
immunosuppressive drugs), history of lymphoma, leukemia, myeloproliferative disorders,
multiple myeloma, or signs and symptoms suggestive of current lymphatic disease.


- Have or have had clinically significant infections within the past 3 months prior to
the first dose of investigational product (eg, those requiring hospitalization or
parenteral antibiotics, or as judged by the Investigator), evidence of any infection
within the past 7 days prior to the first dose of investigational product, herpes
simplex within 12 weeks or history of disseminated herpes simplex infection,
symptomatic herpes zoster or recurrent (>1 episode) or disseminated herpes zoster.


- Have undergone significant trauma or major surgery within 4 weeks of Screening.


- Have been vaccinated with live or attenuated live vaccine within the 6 weeks prior to
the first dose of investigational product, or expects to be vaccinated with these
vaccines during study treatment, or within the 6 weeks following the last dose of
investigational product.Recombinant subunit vaccines (eg, Shingrix®) are permitted and
it is preferable that the last dose is administered at least 4 weeks prior to Day 1.


- Use of prescription or nonprescription drugs and dietary and herbal supplements within
7 days or 5 half-lives (whichever is longer) prior to the first dose of
investigational product.


- Female participants taking hormone replacement therapy within 28 days prior to the
first dose of study treatment.


- A positive urine drug test.


- Screening supine BP ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic), following at least
5 minutes of supine rest. If BP is ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic), the
BP should be repeated 2 more times and the average of the 3 BP values should be used
to determine the participant's eligibility.


- Baseline 12-lead ECG that demonstrates clinically relevant abnormalities that may
affect participant safety or interpretation of study results (eg, baseline QTc
interval >450 msec, complete left bundle branch block [LBBB], signs of an acute or
indeterminate-age myocardial infarction, ST-T interval changes suggestive of
myocardial ischemia, second- or third-degree atrioventricular [AV] block, or serious
bradyarrhythmias or tachyarrhythmias).


- Participants with abnormalities in clinical laboratory tests at screening, as assessed
by the study-specific laboratory


- History of alcohol abuse or binge drinking and/or any other illicit drug use or
dependence within 6 months of Screening.


- Use of tobacco/nicotine containing products in excess of 5 cigarettes/day.


- Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more
within 60 days prior to dosing.


- History of sensitivity to heparin or heparin-induced thrombocytopenia


- Female participants of childbearing potential who are unwilling or unable to use a
highly effective method of contraception for the duration of the study and for at
least 60 days after the last dose of itraconazole.


- Female nursing participants will be excluded.

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Heathy ParticipantsA Study to Investigate the Effect of Multiple Doses of Itraconazole on the Pharmacokinetics of PF-06700841 in Healthy Participants
NCT04090047
  1. New Haven, Connecticut
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE A Study to Investigate the Effect of Multiple Doses of Itraconazole on the Pharmacokinetics of PF-06700841 in Healthy Participants
Official Title  ICMJE A PHASE 1, OPEN-LABEL, FIXED SEQUENCE 2-PERIOD STUDY TO INVESTIGATE THE EFFECT OF MULTIPLE DOSES OF ITRACONAZOLE ON THE PHARMACOKINETICS OF A SINGLE DOSE OF PF-06700841 IN HEALTHY PARTICIPANTS
Brief Summary An open-label, fixed-sequence, 2-period study to investigate the effect of multiple oral doses of itraconazole on a single oral dose of PF-06700841 PK in healthy participants. The study will consist of two treatment periods in one fixed sequence.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Heathy Participants
Intervention  ICMJE
  • Drug: PF-06700841
    PF-06700841 oral tablets in 5mg and 25mg provided for a 30mg dose
  • Drug: Itraconazole
    200 mg oral solution administered as 20 milliliters(mL) (10 mg/mL)
    Other Name: Sporanox®
Study Arms  ICMJE Experimental: PF-06700841 and Itraconazole
This fixed sequence, 2-period arm will consist of two treatments. Participants will receive a single oral dose of 30 milligrams (mg) PF-06700841 on Day 1 in Period 1. On Days 1-7 in Period 2, Itraconazole 200mg will be administered once daily(QD). On Day 4 of Period 2, co-administration of Itraconazole 200 mg and 30 mg PF-06700841 tablets will occur.
Interventions:
  • Drug: PF-06700841
  • Drug: Itraconazole
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: September 12, 2019)		12
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 19, 2019
Actual Primary Completion Date December 19, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male and female participants who are overtly healthy as determined by medical evaluation including a detailed medical history, full physical examination, which includes blood pressure (BP) and pulse rate measurement, clinical laboratory tests, and 12-lead ECG.
  • Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb).

Exclusion Criteria:

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
  • Evidence or history of clinically significant dermatological condition (eg, contact dermatitis or psoriasis) or visible rash present during physical examination.
  • Participant with a history of known hypersensitivity to itraconazole or its excipients or to other azole antifungals.
  • History of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C; positive testing for HIV, hepatitis B core antibody (HBcAb), hepatitis B surface antigen (HBsAg), or hepatitis C antibody (HCVAb). Hepatitis B vaccination is allowed.
  • History of tuberculosis or active or latent or inadequately treated infection, positive QuantiFERON®- tuberculosis (TB) Gold or equivalent test.
  • Have a history of any lymphoproliferative disorder (such as Epstein Barr Virus [EBV] related lymphoproliferative disorder, as reported in some participants on other immunosuppressive drugs), history of lymphoma, leukemia, myeloproliferative disorders, multiple myeloma, or signs and symptoms suggestive of current lymphatic disease.
  • Have or have had clinically significant infections within the past 3 months prior to the first dose of investigational product (eg, those requiring hospitalization or parenteral antibiotics, or as judged by the Investigator), evidence of any infection within the past 7 days prior to the first dose of investigational product, herpes simplex within 12 weeks or history of disseminated herpes simplex infection, symptomatic herpes zoster or recurrent (>1 episode) or disseminated herpes zoster.
  • Have undergone significant trauma or major surgery within 4 weeks of Screening.
  • Have been vaccinated with live or attenuated live vaccine within the 6 weeks prior to the first dose of investigational product, or expects to be vaccinated with these vaccines during study treatment, or within the 6 weeks following the last dose of investigational product.Recombinant subunit vaccines (eg, Shingrix®) are permitted and it is preferable that the last dose is administered at least 4 weeks prior to Day 1.
  • Use of prescription or nonprescription drugs and dietary and herbal supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of investigational product.
  • Female participants taking hormone replacement therapy within 28 days prior to the first dose of study treatment.
  • A positive urine drug test.
  • Screening supine BP ?140 mm Hg (systolic) or ?90 mm Hg (diastolic), following at least 5 minutes of supine rest. If BP is ?140 mm Hg (systolic) or ?90 mm Hg (diastolic), the BP should be repeated 2 more times and the average of the 3 BP values should be used to determine the participant's eligibility.
  • Baseline 12-lead ECG that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results (eg, baseline QTc interval >450 msec, complete left bundle branch block [LBBB], signs of an acute or indeterminate-age myocardial infarction, ST-T interval changes suggestive of myocardial ischemia, second- or third-degree atrioventricular [AV] block, or serious bradyarrhythmias or tachyarrhythmias).
  • Participants with abnormalities in clinical laboratory tests at screening, as assessed by the study-specific laboratory
  • History of alcohol abuse or binge drinking and/or any other illicit drug use or dependence within 6 months of Screening.
  • Use of tobacco/nicotine containing products in excess of 5 cigarettes/day.
  • Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 60 days prior to dosing.
  • History of sensitivity to heparin or heparin-induced thrombocytopenia
  • Female participants of childbearing potential who are unwilling or unable to use a highly effective method of contraception for the duration of the study and for at least 60 days after the last dose of itraconazole.
  • Female nursing participants will be excluded.
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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04090047
Other Study ID Numbers  ICMJE B7931033
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD:No
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d….
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP