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A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Repeat Doses of PF-06372865 in Healthy Subjects

Last updated on June 5, 2019

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Study Location
Pfizer 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 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.
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1. Healthy female subjects of non-childbearing potential and/or male subjects between the
ages of 18 and 55 years

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

3. Subjects who are willing and able to comply with all study procedures (including being
able to swallow up to 8 tablets/dose or 16 tablets/day)

4. For optional Japanese subjects only: Japanese subjects currently residing in the
United States who have 4 biologic Japanese grandparents born in Japan

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, neurologic, or
allergic disease

2. Subjects with history of sleep apnea

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

4. Positive urine drug test

5. History of regular alcohol consumption exceeding 7 drinks/week for females or 14
drinks/week for males

6. Treatment with an investigational drug within 30 days or 5 half-lives of the first
dose of PF-06372865 (whichever is longer)

7. Clinically significant orthostatic hypotension at screening or screening supine BP
>=140 mm Hg (systolic) or >=90 mm Hg (diastolic), following at least 5 minutes of
supine rest

8. Screening supine 12-lead ECG demonstrating a corrected QT (QTc) interval >450 msec or
a QRS interval >120 msec

9. Subjects with any of the following abnormalities in clinical laboratory tests at
screening: aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level
>=1.5x upper limit of normal (ULN); total bilirubin level >=1.5x 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

10. Fertile male subjects 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 PF-06372865

11. Male subjects whose partners are currently pregnant

12. 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 PF-06372865

13. Use of herbal supplements or hormone replacement therapy within 28 days prior to the
first dose of PF-06372865

14. Blood donation of approximately 1 pint (500 mL) or more within 60 days prior to dosing

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

16. History of human immunodeficiency virus (HIV), hepatitis B, or hepatitis C; positive
testing for HIV, hepatitis B surface antigen, hepatitis B core antibody, or hepatitis
C antibody

17. Other acute or chronic medical or psychiatric condition including recent or active
suicidal ideation or behavior or laboratory abnormality that may increase the risk
associated with study participation or PF-06372865 administration or may interfere
with the interpretation of study results

18. Subjects with active suicidal ideations or suicidal behavior within 5 years prior to
screening

19. Subjects with history of cyclic neutropenia.

20. Subjects with known history of hypersensitivity to benzodiazepines, or for whom
benzodiazepines would be contraindicated

21. Subjects who have previously been exposed to, or participated in a study with,
PF-06372865

22. Subjects with folate deficiency

23. Subjects who have had an X-ray within 4 weeks prior to screening

NCT03351751
Pfizer
Completed
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Repeat Doses of PF-06372865 in Healthy Subjects

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[email protected]

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