Clinical trial NCT02936154: Study for MR Formulation of PF-06650833 in Healthy Adult Japanese Subjects
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2016-10-18
Enrollment: 10
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of participants experiencing an AE/SAE
timeFrame: Day 18
Secondary outcomes:
measure: Maximum plasma concentration (Cmax)
timeFrame: Day 1 and Day 10
measure: Area under the plasma concentration time curve for dosing interval (AUCtau)
timeFrame: Day 1 and Day 10
measure: Time to peak concentration
timeFrame: Day 1 and Day 10
measure: Clearance
timeFrame: Day 10
measure: Volume of distribution
timeFrame: Day 10
measure: Observed exposure accumulation ratio for AUCtau
timeFrame: Day 10
measure: Observed exposure accumulation ratio for Cmax
timeFrame: Day 10
measure: Minimum plasma concentration (Cmin)
timeFrame: Days 2, 4, 7 and 10
measure: Fluctuation ratio (Cmax:Cmin)
timeFrame: Day 10
measure: Mean residence time
timeFrame: Day 10
measure: change from baseline in vital signs
timeFrame: Day 18
measure: change form baseline in electrocardiogram (ECG) parameters
timeFrame: Day 18
measure: Incidence of treatment emergent clinical laboratory abnormalities
timeFrame: Day 18
Other outcomes:
Locations:
city: Hachioji-shi
country: Japan
facility: P-one Clinic, Keikokai Medical Corporation
state: Tokyo
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: