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Drug Interaction Study Evaluating the Effect of Rifampin on PK and Safety of PF 04965842.

Last updated on March 14, 2019

Study Location
Pfizer Clinical Research Unit
Brussels, , B-1070 Belgium
Eligibility criteria
The disease, disorder, syndrome, illness, or injury that is being studied.
Females and Males
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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Subjects must meet all of the following inclusion criteria to be eligible for enrollment in
the study:

1. Healthy female subjects and/or male subjects who, at the time of screening, are
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 (BP) and pulse rate measurement, 12 lead ECG, or
clinical laboratory tests.

Female subjects of non childbearing potential must meet at least 1 of the following

1. Achieved postmenopausal status, defined as follows: cessation of regular menses
for at least 12 consecutive months with no alternative pathological or
physiological cause; status may be confirmed with a serum follicle stimulating
hormone (FSH) level confirming the postmenopausal state;

2. Have undergone a documented hysterectomy and/or bilateral oophorectomy;

3. Have medically confirmed ovarian failure. All other female subjects (including
female subjects with tubal ligations) are considered to be of childbearing

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

3. Evidence of a personally signed and dated informed consent document indicating that
the subject has been informed of all pertinent aspects of the study.

4. Subjects who are willing and able to comply with all scheduled visits, treatment plan,
laboratory tests, and other study procedures.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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Subjects with any of the following characteristics/conditions will not be included in the

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. Subjects with history of psoriasis, AD or eczema can be included
in the study.

2. Subjects, who according to the product label for rifampin, would be at increased risk
if dosed with rifampin.

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

4. A positive urine drug test.

5. History of regular alcohol consumption exceeding 14 drinks/week for female subjects or
21 drinks/week for male subjects (1 drink = 5 ounces [150 mL] of wine or 12 ounces
[360 mL] of beer or 1.5 ounces [45 mL] of hard liquor) within 6 months before

6. Treatment 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
(whichever is longer).

7. Screening supine systolic BP 140 mm Hg following at least 5 minutes of
supine rest OR Screening supine diastolic BP 90 mm Hg following at least
5 minutes of supine rest.

If a subject 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 subject's eligibility.

8. 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 subject's eligibility.

9. Pregnant female subjects; breastfeeding female subjects; fertile male subjects and
female subjects 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.

10. 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 test, if deemed necessary:

- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level 1.5 ×
upper limit of normal (ULN);

- Total bilirubin level 1 × 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.

11. Use of CYP2C19 inhibitors (eg, fluconazole, fluoxetine, fluvoxamine, ticlopidine
omeprazole, voriconazole, cimetidine, esomeprazole, and felbamate) or inducers (eg,
rifampin, ritonavir, efavirenz, enzalutamide, phenytoin, and St. John's Wort) within
28 days or 5 half lives (whichever is longer) prior to dosing.

12. Use of CYP2C9 inhibitors (eg, amiodarone, felbamate, fluconazole, miconazole,
piperine, diosmin, disulfiram, fluvastatin, fluvoxamine, voriconazole, efavirenz,
isoniazid) or inducers (eg, aprepitant, carbamazepine, enzalutamide, rifampin,
ritonavir, nevirapine, phenobarbital, and St. John's Wort) within 28 days or 5 half
lives (whichever is longer) prior to dosing.

13. Use of CYP3A4 inhibitors (eg, ketoconazole, ciprofloxacin, diltiazem) or other
inducers (eg, phenytoin, carbamazepine) within 28 days or 5 half lives (whichever is
longer) prior to dosing.

14. Known relevant history of elevated liver function tests (LFTs) or impaired liver

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

16. 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 dermatomal herpes zoster.

- History of systemic infection requiring hospitalization, parenteral antimicrobial
therapy, or considered clinically significant by the investigator within 6 months
prior to screening.

17. History of receiving a live vaccine within 6 weeks prior to the first dose of
investigational product, or is expected to receive a live vaccine within 6 weeks after
the last dose of investigational product.

18. Have a known immunodeficiency disorder or a first degree relative with a hereditary

19. 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.

20. Use of prescription or nonprescription drugs and dietary supplements within 7 days or
5 half lives (whichever is longer) prior to the first dose of investigational product.
As an exception, acetaminophen/paracetamol may be used at doses of use of nonprescription medications that are not believed to affect subject safety or
the overall results of the study may be permitted on a case by case basis following
approval by the sponsor.

Herbal supplements and hormonal methods of contraception (including oral and
transdermal contraceptives, injectable progesterone, progestin subdermal implants,
progesterone releasing intrauterine devices [IUDs], vaginal ring, and postcoital
contraceptive methods) and hormone replacement therapy must have been discontinued at
least 28 days prior to the first dose of investigational product.

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

22. History of sensitivity to heparin or heparin induced thrombocytopenia.

23. History of human immunodeficiency virus (HIV), hepatitis B, or hepatitis C; positive
testing for HIV, hepatitis B surface antigen (HepBsAg), hepatitis B core antibody
(HepBcAb), or hepatitis C antibody (HCVAb). A positive hepatitis B surface antibody
(HepBsAb) finding as a result of subject vaccination is permissible.

24. A current or past medical history of conditions associated with thrombocytopenia,
coagulopathy or platelet dysfunction.

25. Unwilling or unable to comply with the criteria in the Lifestyle Requirements section
of this protocol.

26. Subjects who are 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 subjects who are Pfizer employees, including their family members,
directly involved in the conduct of the study.

27. 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 subject inappropriate for entry into this

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

Drug Interaction Study Evaluating the Effect of Rifampin on PK and Safety of PF 04965842.


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