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Study to Evaluate Pharmacokinetics of A Modified Release Formulation of PF-06650833 in Healthy Subjects

Last updated on May 11, 2018

FOR MORE INFORMATION
Study Location
New Haven Clinical Research Unit
New Haven, Connecticut, 06511 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

1. Healthy female subjects of non childbearing potential and/or male subjects, between
the ages of 18 and 55 years

2. BMI of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).

3. Personally signed and dated Informed Consent

4. Willing and able to comply with scheduled visits, treatment plan, laboratory tests,
and other study procedures.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

1. Clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal,
cardiovascular, hepatic, psychiatric, neurologic, or allergic disease

2. Any condition possibly affecting drug absorption

3. Positive urine drug screen.

4. Heavy smokers

5. History of regular heavy alcohol consumption within 6 months of Screening.

6. Treatment with an investigational drug within 30 days (or as determined by the local
requirement) or 5 half lives

7. Screening supine blood pressure or>=140 mm Hg (systolic) or >=90 mm Hg (diastolic), following at least 5 minutes of
supine rest.

8. Screening pulse (HR) >100 bpm after at least 5 minutes of rest.

9. Single supine 12 lead ECG demonstrating QTc >450 msec or a QRS interval >120 msec at
Screening.

10. Abnormal chest X ray

11. History of TB or active or latent or inadequately treated infection, positive
Quantiferon TB test.

12. History of hepatitis or positive testing for human HIV,HepBsAg, HepBc Ab or HCVAb

13. Any medical history of disease [ie, Gilbert's disease] that has the potential to cause
a rise in total bilirubin over the ULN

14. Clinical laboratory abnormalities including:

- Creatine kinase >1.2 X ULN;

- CK MB > ULN;

- Serum myoglobin >1.2 X ULN;

- Cardiac Troponin I (cTn I) > ULN of the laboratory reference range;

- Serum aspartate transaminase (AST) or alanine transaminase (ALT) >=2 x ULN, total
serum bilirubin >=1.5 mg/dL;

- Subjects with benign ethnic neutropenia;

- Hemoglobin

15. Nursing female subjects; male subjects with partners currently pregnant; male subjects
able to father children who are unwilling or unable to use a highly effective method
of contraception as outlined in this protocol for the duration of the study and for 28
days after the last dose of investigational product or longer based upon the
compound's half life characteristics.

16. Use of prescription or nonprescription drugs and dietary supplements within 7 days or
5 half lives (whichever is longer) prior to the first dose of investigational product
until discharge from the study at the end of Period 2.

Herbal supplements and hormone replacement therapy must be discontinued 28 days prior
to the first dose of investigational product. Acetaminophen/paracetamol should not be
used. As an exception, ibuprofen may be used at doses of 200 to 400 mg orally every 6
hours as needed for up to 3 of 7 consecutive days.

17. Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more
within 56 days prior to dosing.

18. History of sensitivity to heparin or heparin induced thrombocytopenia.

19. History of cancer (other than treated basal cell and squamous cell carcinoma of the
skin) in the previous 5 years.

20. Previous exposure to PF 06650833.

21. Unwilling or unable to comply with the Lifestyle guidelines

22. 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.

23. Other severe acute or chronic medical or psychiatric condition or laboratory
abnormality

NCT02609139
Pfizer
Completed
Study to Evaluate Pharmacokinetics of A Modified Release Formulation of PF-06650833 in Healthy Subjects

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Study to Evaluate Pharmacokinetics of A Modified Release Formulation of PF-06650833 in Healthy Subjects
A Phase 1, Open Label, Single?Dose, Within Cohort Randomized, 2?Way Crossover Study To Evaluate The Pharmacokinetics Of A Modified Release Formulation Of Pf?06650833 Under Fasting And Fed Conditions In Healthy Adult Subjects
This is a Phase 1, open-label, single-dose, within-cohort randomized, 2-way crossover study to evaluate the PK of orally administered PF-06650833 modified release tablets under fasted and high fat meal fed conditions in healthy subjects.
This is the third study of PF-06650833. The goals of the study are to assess the PK in healthy subjects of single doses of modified release (MR) tablets of PF-06650833 when orally administered under fasting and high fat meal fed conditions.
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Healthy
  • Drug: PF-06650833
    Up to 400mg modified release tablets administered under fasted conditions
  • Drug: PF-06650833
    100mg modified release tablet administered under fasted conditions
  • Drug: PF-06650833
    20mg modified release tablet administered under fasted conditions
  • Drug: PF-06650833
    Up to 400mg modified release tablets administered with high fat meal food intake
  • Drug: PF-06650833
    100mg modified released tablet administered with high fat meal food intake
  • Drug: PF-06650833
    20 mg modified release tablet administered with high fat meal food intake
  • Experimental: <=400mg Modified Release Tablets, Fasted
    Up to 400 mg PF-06650833 modified release tablets administered under fasted conditions
    Intervention: Drug: PF-06650833
  • Experimental: 100mg Modified Release Tablets, Fasted
    100 mg PF-06650833 modified release tablets administered under fasted conditions
    Intervention: Drug: PF-06650833
  • Experimental: 20mg Modified Release Tablets, Fasted
    20 mg PF-06650833 modified release tablets administered under fasted conditions
    Intervention: Drug: PF-06650833
  • Experimental: <= 400mg Modified Release Tablets, Fed
    Up to 400 mg PF-06650833 modified release tablets administered with high fat meal food intake
    Intervention: Drug: PF-06650833
  • Experimental: 100mg Modifed Release Tablets, Fed
    100 mg PF-06650833 modified release tablets administered with high fat meal food intake
    Intervention: Drug: PF-06650833
  • Experimental: 20mg Modified Release Tablets, Fed
    20 mg PF-06650833 modified release tablets administered with high fat meal food intake
    Intervention: Drug: PF-06650833
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
February 2016
February 2016   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Healthy female subjects of non childbearing potential and/or male subjects, between the ages of 18 and 55 years
  2. BMI of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
  3. Personally signed and dated Informed Consent
  4. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion Criteria:

  1. Clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease
  2. Any condition possibly affecting drug absorption
  3. Positive urine drug screen.
  4. Heavy smokers
  5. History of regular heavy alcohol consumption within 6 months of Screening.
  6. Treatment with an investigational drug within 30 days (or as determined by the local requirement) or 5 half lives
  7. Screening supine blood pressure <=100 mm Hg (systolic) or<=50 mm Hg (diastolic) or>=140 mm Hg (systolic) or >=90 mm Hg (diastolic), following at least 5 minutes of supine rest.
  8. Screening pulse (HR) >100 bpm after at least 5 minutes of rest.
  9. Single supine 12 lead ECG demonstrating QTc >450 msec or a QRS interval >120 msec at Screening.
  10. Abnormal chest X ray
  11. History of TB or active or latent or inadequately treated infection, positive Quantiferon TB test.
  12. History of hepatitis or positive testing for human HIV,HepBsAg, HepBc Ab or HCVAb
  13. Any medical history of disease [ie, Gilbert's disease] that has the potential to cause a rise in total bilirubin over the ULN
  14. Clinical laboratory abnormalities including:

    • Creatine kinase >1.2 X ULN;
    • CK MB > ULN;
    • Serum myoglobin >1.2 X ULN;
    • Cardiac Troponin I (cTn I) > ULN of the laboratory reference range;
    • Serum aspartate transaminase (AST) or alanine transaminase (ALT) >=2 x ULN, total serum bilirubin >=1.5 mg/dL;
    • Subjects with benign ethnic neutropenia;
    • Hemoglobin <=14 gm/dl (males) and <=13 gm/dL (females).
  15. Nursing female subjects; male subjects with partners currently pregnant; male subjects able to father children who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for 28 days after the last dose of investigational product or longer based upon the compound's half life characteristics.
  16. Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half lives (whichever is longer) prior to the first dose of investigational product until discharge from the study at the end of Period 2.

    Herbal supplements and hormone replacement therapy must be discontinued 28 days prior to the first dose of investigational product. Acetaminophen/paracetamol should not be used. As an exception, ibuprofen may be used at doses of 200 to 400 mg orally every 6 hours as needed for up to 3 of 7 consecutive days.

  17. Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 56 days prior to dosing.
  18. History of sensitivity to heparin or heparin induced thrombocytopenia.
  19. History of cancer (other than treated basal cell and squamous cell carcinoma of the skin) in the previous 5 years.
  20. Previous exposure to PF 06650833.
  21. Unwilling or unable to comply with the Lifestyle guidelines
  22. 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.
  23. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02609139
B7921004
IRAK4 MR PK Study ( Other Identifier: Alias Study Number )
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
May 2016

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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[email protected]



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