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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02936154
• Other study ID #: B7921006
• Status: Completed
• Phase: Phase 1
• Start date: August 2016
• Est. completion date: October 2016

Study information

• Verified date: October 2018
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• PF-06650833

• placebo

Locations

Country	Name	City	State
Japan	P-one Clinic, Keikokai Medical Corporation	Hachioji-shi	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants experiencing an AE/SAE		Day 18
Secondary	Maximum plasma concentration (Cmax)		Day 1 and Day 10
Secondary	Area under the plasma concentration time curve for dosing interval (AUCtau)		Day 1 and Day 10
Secondary	Time to peak concentration		Day 1 and Day 10
Secondary	Clearance		Day 10
Secondary	Volume of distribution		Day 10
Secondary	Observed exposure accumulation ratio for AUCtau		Day 10
Secondary	Observed exposure accumulation ratio for Cmax		Day 10
Secondary	Minimum plasma concentration (Cmin)		Days 2, 4, 7 and 10
Secondary	Fluctuation ratio (Cmax:Cmin)		Day 10
Secondary	Mean residence time		Day 10
Secondary	change from baseline in vital signs		Day 18
Secondary	change form baseline in electrocardiogram (ECG) parameters		Day 18
Secondary	Incidence of treatment emergent clinical laboratory abnormalities		Day 18

External Links

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