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Trial record 1 of 1 for:    NCT02936154
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Study for MR Formulation of PF-06650833 in Healthy Adult Japanese Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02936154
Recruitment Status : Completed
First Posted : October 18, 2016
Last Update Posted : October 5, 2018
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Healthy Drug: PF-06650833 Drug: placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Official Title: 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
Actual Study Start Date : August 2016
Actual Primary Completion Date : October 2016
Actual Study Completion Date : October 2016

Arm Intervention/treatment
Experimental: 300 mg Drug: PF-06650833
Placebo Comparator: placebo Drug: placebo

Primary Outcome Measures :
  1. Number of participants experiencing an AE/SAE [ Time Frame: Day 18 ]

Secondary Outcome Measures :
  1. Maximum plasma concentration (Cmax) [ Time Frame: Day 1 and Day 10 ]
  2. Area under the plasma concentration time curve for dosing interval (AUCtau) [ Time Frame: Day 1 and Day 10 ]
  3. Time to peak concentration [ Time Frame: Day 1 and Day 10 ]
  4. Clearance [ Time Frame: Day 10 ]
  5. Volume of distribution [ Time Frame: Day 10 ]
  6. Observed exposure accumulation ratio for AUCtau [ Time Frame: Day 10 ]
  7. Observed exposure accumulation ratio for Cmax [ Time Frame: Day 10 ]
  8. Minimum plasma concentration (Cmin) [ Time Frame: Days 2, 4, 7 and 10 ]
  9. Fluctuation ratio (Cmax:Cmin) [ Time Frame: Day 10 ]
  10. Mean residence time [ Time Frame: Day 10 ]
  11. change from baseline in vital signs [ Time Frame: Day 18 ]
  12. change form baseline in electrocardiogram (ECG) parameters [ Time Frame: Day 18 ]
  13. Incidence of treatment emergent clinical laboratory abnormalities [ Time Frame: Day 18 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02936154

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P-one Clinic, Keikokai Medical Corporation
Hachioji-shi, Tokyo, Japan, 192-0071
Sponsors and Collaborators
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Study Director: Pfizer Call Center Pfizer

Additional Information:
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Responsible Party: Pfizer Identifier: NCT02936154    
Other Study ID Numbers: B7921006
First Posted: October 18, 2016    Key Record Dates
Last Update Posted: October 5, 2018
Last Verified: October 2018