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

Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT02936154
Collaborator
(none)
10
Enrollment
1
Location
2
Arms
2
Actual Duration (Months)
5
Patients Per Site Per Month

Study Details

Study Description

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
Phase 1

Study Design

Study Type:
Interventional
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 :
Aug 1, 2016
Actual Primary Completion Date :
Oct 1, 2016
Actual Study Completion Date :
Oct 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: 300 mg

Drug: PF-06650833
Placebo Comparator: placebo

Drug: placebo

Outcome Measures

Primary Outcome Measures

  1. Number of participants experiencing an AE/SAE [Day 18]

Secondary Outcome Measures

  1. Maximum plasma concentration (Cmax) [Day 1 and Day 10]

  2. Area under the plasma concentration time curve for dosing interval (AUCtau) [Day 1 and Day 10]

  3. Time to peak concentration [Day 1 and Day 10]

  4. Clearance [Day 10]

  5. Volume of distribution [Day 10]

  6. Observed exposure accumulation ratio for AUCtau [Day 10]

  7. Observed exposure accumulation ratio for Cmax [Day 10]

  8. Minimum plasma concentration (Cmin) [Days 2, 4, 7 and 10]

  9. Fluctuation ratio (Cmax:Cmin) [Day 10]

  10. Mean residence time [Day 10]

  11. change from baseline in vital signs [Day 18]

  12. change form baseline in electrocardiogram (ECG) parameters [Day 18]

  13. Incidence of treatment emergent clinical laboratory abnormalities [Day 18]

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 55 Years
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 P-one Clinic, Keikokai Medical Corporation Hachioji-shi Tokyo Japan 192-0071

Sponsors and Collaborators

  • Pfizer

Investigators

  • Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Pfizer
ClinicalTrials.gov Identifier:
NCT02936154
Other Study ID Numbers:
  • B7921006
First Posted:
Oct 18, 2016
Last Update Posted:
Oct 5, 2018
Last Verified:
Oct 1, 2018

Study Results

No Results Posted as of Oct 5, 2018