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A Study to Assess Pharmacokinetics of PF-04965842 and Its Metabolites and Effect of Probenecid in Healthy Participants

Last updated on May 24, 2019

FOR MORE INFORMATION
Study Location
New Haven Clinical Research Unit
New Haven, Connecticut, 06511 United States
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.
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1. Male and female participants must be 18 to 55 years of age, inclusive, at the time of
signing the informed consent document (ICD).

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

3. Participants who are willing and able to comply with all scheduled visits, treatment
plan, laboratory tests, lifestyle considerations, and other study procedures.

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

5. Capable of giving signed informed consent , which includes compliance with the
requirements and restrictions listed in the informed consent document (ICD) and in
this protocol.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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1. 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 of acute exacerbation of
dermatological condition (eg, AD, eczema or psoriasis) or visible rash present during
physical examination. Participants with history of psoriasis, AD or eczema can be
included in the study.

2. Participants, who according to the product label for probenecid, would be at increased
risk if dosed with probenecid, including participants with known blood dyscrasias,
uric acid kidney stones, gout, or gouty arthritis.

3. Any condition possibly affecting drug absorption (eg, gastrectomy).

4. Known relevant history or current elevations of liver function tests (LFTs) or
impaired liver function.

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

6. Any history of chronic infections, any history of recurrent infections, any history of
latent infections, or any acute infection within 2 weeks of screening. History of
disseminated herpes zoster, or disseminated herpes simplex, or recurrent localized
multi-dermatomal herpes zoster.

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

8. History or evidence of any malignancies with the exception of adequately treated or
excised non-metastatic basal cell or squamous cell cancer of the skin, or cervical
carcinoma in situ.

9. Other acute or chronic medical or psychiatric condition including recent (within the
past year) or active suicidal ideation or behavior or laboratory abnormality that may
increase the risk associated with study participation or investigational product
administration or may interfere with the interpretation of study results and, in the
judgment of the investigator, would make the participant inappropriate for entry into
this study.

10. 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.

11. Previous administration with an investigational drug within 30 days (or as determined
by the local requirement) or 5 half-lives preceding the first dose of investigational
product used in this study (whichever is longer).

12. A positive urine drug test.

13. Screening supine systolic blood pressure (BP) least 5 minutes of supine rest OR Screening supine diastolic BP = 90 mm
Hg following at least 5 minutes of supine rest. If a participant meets any of these
criteria, 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.

14. Screening supine 12-lead ECG demonstrating a corrected QT (QTc) interval >450 msec or
a QRS interval >120 msec. If QTc exceeds 450 msec, or QRS exceeds 120 msec, the ECG
should be repeated 2 more times and the average of the 3 QTc or QRS values should be
used to determine the participant's eligibility.

15. Participants 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 test, if deemed necessary:

1. Absolute neutrophil count of

2. Hemoglobin

3. Absolute lymphocyte count

4. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level>= 2 *
upper limit of normal (ULN);

5. Total bilirubin level >1 * ULN; participants 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

6. Uric acid not within the normal reference range;

7. Platelet count of

8. Estimated creatinine clearance calculation, or serum creatine >1.5 times the ULN.

16. History of alcohol abuse or binge drinking and/or any other illicit drug use or
dependence within 6 months of Screening. Binge drinking is defined as a pattern of 5
(male) and 4 (female) or more alcoholic drinks in about 2 hours. As a general rule,
alcohol intake should not exceed 14 units per week (1 unit = 8 ounces (240 mL) beer, 1
ounce (30 mL) of 40% spirit or 3 ounces (90 mL) of wine).

17. Use of tobacco or nicotine-containing products in excess of the equivalent of 5
cigarettes per day or 2 chews of tobacco per day.

18. Pregnant female participants; breastfeeding female participants; female participants
of childbearing potential who are unwilling or unable to use 1 highly effective method
of contraception as outlined in this protocol Contraception section for the duration
of the study and for at least 28 days after the last dose of investigational product.

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

20. History of sensitivity to heparin or heparin-induced thrombocytopenia.

21. Unwilling or unable to comply with the criteria in the Lifestyle Considerations
section of this protocol.

22. Investigator site staff members directly involved in the conduct of the study and
their family members, site staff members otherwise supervised by the investigator, or
Pfizer employees, including their family members, directly involved in the conduct of
the study.

NCT03937258
Pfizer
Not yet recruiting
A Study to Assess Pharmacokinetics of PF-04965842 and Its Metabolites and Effect of Probenecid in Healthy Participants

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Pfizer Clinical Trials Contact Center

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[email protected]

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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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