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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: placebo; Drug: PF-06650833

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Tokyo
    • Hachioji-shi, Tokyo, Japan, 192-0071
      • P-One Clinic, Keikokai Medical Corporation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: placebo	Drug: placebo
Experimental: 300 mg	Drug: PF-06650833

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of participants experiencing an AE/SAE	Day 18

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2016
• Primary Completion (Actual): October 1, 2016
• Study Completion (Actual): October 1, 2016

Study Registration Dates

• First Submitted: August 8, 2016
• First Submitted That Met QC Criteria: October 14, 2016
• First Posted (Estimate): October 18, 2016

Study Record Updates

• Last Update Posted (Actual): October 5, 2018
• Last Update Submitted That Met QC Criteria: October 3, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: B7921006