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Study of PF-04965842 Effect on Dabigatran Pharmacokinetics in Healthy Participants

Last updated on March 19, 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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Participants are eligible to be included in the study only if all of the following criteria

Age and Sex:

1. Male and female participants must be 18 to 55 years of age, inclusive, at the time of
signing the informed consent document (ICD).

Type of Participant and Disease Characteristics:

2. Male and female participants who are overtly healthy as determined by medical
evaluation including a detailed medical history, complete physical examination,
laboratory tests, and ECG.

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).

Informed Consent:

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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Participants are excluded from the study if any of the following criteria apply:

Medical Conditions:

1. Evidence or history of clinically significant hematological, renal, endocrine,
pulmonary, gastrointestinal, cardiovascular, hepatic (including alcoholic liver
disease, nonalcoholic steatohepatitis (NASH), autoimmune hepatitis, and hereditary
liver diseases), psychiatric, neurological, or allergic disease (including drug
allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of

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

3. Participants, who according to the product label for dabigatran, would be at increased
risk if dosed with dabigatran.

4. Risks of bleeding including prior personal or familiar history of abnormal bleeding,
hereditary or acquired coagulation or platelet disorder or abnormal coagulation test
(prothrombin time [PT]/international normalized ratio [INR] or partial thromboplastin
time [PTT]/activated partial thromboplastin time [aPTT] greater than upper limit of
normal [ULN]) result at screening.

5. Surgery planned within 4 weeks after the end of the study.

6. Self reported history or risk factors for QT prolongation or torsades de pointes (eg,
organic heart disease, congestive heart failure, hypokalemia, hypomagnesaemia,
congenital long QT syndrome, myocardial ischemia or infarction), congenital deafness,
family history of sudden death, and family history of long QT syndrome.

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

8. History of human immunodeficiency virus (HIV), hepatitis B virus, or hepatitis C virus
infection; positive testing for HIV, hepatitis B surface antigen (HepBsAg), hepatitis
B core antibody (HepBcAb), or hepatitis C antibody (HCVAb).

As an exception, a positive HepBsAb as a result of participant vaccination is

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.

Prior/Concomitant Therapy:

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.

Prior/Concurrent Clinical Study Experience:

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).

Diagnostic Assessments:

12. A positive urine drug test.

13. Screening supine systolic blood pressure (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 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

14. Screening supine 12 lead ECG demonstrating:

- QTcF >450 msec; OR

- QRS interval >120 msec. If QTcF exceeds 450 msec, or QRS exceeds 120 msec, the
ECG should be repeated 2 more times and the average of the 3 QTcF 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:

- Aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase (SGOT)
or alanine aminotransferase (ALT)/serum glutamic pyruvic transaminase (SGPT)
level >=1.5 × ULN;

- Total bilirubin level > 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


- Estimated creatinine clearance

Other Exclusions:

16. History of regular alcohol consumption exceeding 14 drinks/week for female
participants or 21 drinks/week for male participants (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 screening.

17. Known relevant history of elevated liver function tests (LFTs).

18. History of tuberculosis (TB) (active or latent) or inadequately treated TB infection.
Positive QuantiFERON - TB Gold test.

19. Any history of chronic infections, any history of recurrent infections, any history of
latent infections, or any acute infection within 2 weeks of baseline.

20. History of disseminated herpes zoster, or disseminated herpes simplex, or recurrent
localized dermatomal herpes zoster.

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

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

23. Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more
within 60 days prior to first dose of investigational product.

24. History of hypersensitivity to dabigatran.

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

26. Have any malignancies or have a history of 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.

27. 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.

Study of PF-04965842 Effect on Dabigatran Pharmacokinetics in Healthy Participants


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