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Study for MR Formulation of PF-06650833 in Healthy Adult Japanese Subjects

Last updated on March 15, 2019

FOR MORE INFORMATION
Study Location
P-one Clinic, Keikokai Medical Corporation
Hachioji-shi, Tokyo, 192-0071 Japan
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
20-55 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 Japanese subjects
between the ages of 20 and 55 years, inclusive.

2. Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).

3. Subject must have four Japanese grandparents who were born in Japan.

4. Evidence of a personally signed and dated informed consent document.

5. 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.
Show details

1. Evidence or history of clinically significant hematological, renal, endocrine,
pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or
allergic disease.

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

3. A positive urine drug screen.

4. Smoking cigarettes with exceeding provided criteria.

5. History of regular alcohol consumption exceeding provided limitations.

6. Treatment with an investigational drug within a provided criteria.

7. Abnormal supine blood pressure.

8. Abnormal pulse rate.

9. Abnormal 12 lead ECG.

10. History of tuberculosis.

11. History of hepatitis or positive testing for HIV, hepatitis B surface antigen,
hepatitis B surface antibodies, hepatitis B core antibodies, hepatitis C antibodies or
syphilis.

12. Any medical history of disease (ie, Gilbert's disease).

13. Abnormal clinical laboratory test related to cardiac and skeletal muscle injury.

14. Male subjects with partners currently pregnant; unwilling or unable to use a highly
effective method of contraception

15. Use of prescription or nonprescription drugs, vitaminic and dietary supplements within
a specified duration.

16. Blood donation exceeding a provided limitation.

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

18. History of cancer (other than treated basal cell and squamous cell carcinoma of the
skin) in the previous 5 years.

19. Unwilling or unable to comply with the Lifestyle guidelines described in this
protocol.

20. Subjects who are investigational 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 directly involved in the conduct of
the study.

21. Other severe acute or chronic medical or psychiatric condition or laboratory
abnormality.

NCT02936154
Pfizer
Completed
Study for MR Formulation of PF-06650833 in Healthy Adult Japanese Subjects

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Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[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:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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