Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
 
ClinicalTrials.gov Identifier: NCT02936154
Recruitment Status : Completed
First Posted : October 18, 2016
Last Update Posted : October 5, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE August 8, 2016
First Posted Date  ICMJE October 18, 2016
Last Update Posted Date October 5, 2018
Actual Study Start Date  ICMJE August 2016
Actual Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 26, 2016)
Number of participants experiencing an AE/SAE [ Time Frame: Day 18 ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 14, 2016)
  • Number of participants experiencing an AE/SAE [ Time Frame: Day 18 ]
  • Changes from baseline in vital signs (blood pressure and pulse rate). [ Time Frame: Baseline, Day 4, 7, 11, 18 ]
  • Changes from baseline in electrocardiogram (ECG) parameters (standard 12 lead ECG) [ Time Frame: Baseline, Day 4, 7, 11, 18 ]
  • Incidence and magnitude of treatment emergent clinical laboratory abnormalities [ Time Frame: Baseline, Day 4, 7, 11, 18 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 26, 2016)
  • Maximum plasma concentration (Cmax) [ Time Frame: Day 1 and Day 10 ]
  • Area under the plasma concentration time curve for dosing interval (AUCtau) [ Time Frame: Day 1 and Day 10 ]
  • Time to peak concentration [ Time Frame: Day 1 and Day 10 ]
  • Clearance [ Time Frame: Day 10 ]
  • Volume of distribution [ Time Frame: Day 10 ]
  • Observed exposure accumulation ratio for AUCtau [ Time Frame: Day 10 ]
  • Observed exposure accumulation ratio for Cmax [ Time Frame: Day 10 ]
  • Minimum plasma concentration (Cmin) [ Time Frame: Days 2, 4, 7 and 10 ]
  • Fluctuation ratio (Cmax:Cmin) [ Time Frame: Day 10 ]
  • Mean residence time [ Time Frame: Day 10 ]
  • change from baseline in vital signs [ Time Frame: Day 18 ]
  • change form baseline in electrocardiogram (ECG) parameters [ Time Frame: Day 18 ]
  • Incidence of treatment emergent clinical laboratory abnormalities [ Time Frame: Day 18 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 14, 2016)
  • Maximum plasma concentration (Cmax) [ Time Frame: Day 1 and Day 10 ]
  • Area under the plasma concentration time curve for dosing interval (AUCtau) [ Time Frame: Day 1 and Day 10 ]
  • Time to peak concentration [ Time Frame: Day 1 and Day 10 ]
  • Clearance [ Time Frame: Day 10 ]
  • Volume of distribution [ Time Frame: Day 10 ]
  • Observed exposure accumulation ratio for AUCtau [ Time Frame: Day 10 ]
  • Observed exposure accumulation ratio for Cmax [ Time Frame: Day 10 ]
  • Minimum plasma concentration (Cmin) [ Time Frame: Days 2, 4, 7 and 10 ]
  • Fluctuation ratio (Cmax:Cmin) [ Time Frame: Day 10 ]
  • Mean residence time [ Time Frame: Day 10 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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