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

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NCT02936154

Last updated on January 23, 2020
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FOR MORE INFORMATION
Study Location
P-one Clinic, Keikokai Medical Corporation
Hachioji-shi, Tokyo, 192-0071 Japan
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
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.
Show details

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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[email protected]

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Descriptive Information
Brief Title  ICMJE Study for MR Formulation of PF-06650833 in Healthy Adult Japanese Subjects
Official Title  ICMJE A Phase 1, Double Blind (Sponsor Open), Placebo-controlled, Multiple-dose Study To Evaluate The Tolerability, Safety And Pharmacokinetics Of A Modified Release Formulation Of Pf-06650833 Under Fed Condition In Healthy Adult Japanese Subjects
Brief Summary The purpose of this study is to evaluate the tolerability, safety and pharmacokinetics of PF-06650833 orally administered as modified release tablets in healthy Japanese subjects.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: PF-06650833
  • Drug: placebo
Study Arms  ICMJE
  • Experimental: 300 mg
    Intervention: Drug: PF-06650833
  • Placebo Comparator: placebo
    Intervention: Drug: placebo
Publications * Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 14, 2016) 		10
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2016
Actual Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  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:

  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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02936154
Other Study ID Numbers  ICMJE B7921006
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date October 2018

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

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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