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A DRUG-DRUG INTERACTION STUDY BETWEEN PF-06650833 AND PF-06651600 FOLLOWING MULTIPLE DOSES IN HEALTHY PARTICIPANTS

Last updated on May 24, 2019

FOR MORE INFORMATION
Study Location
Pfizer 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.
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- Male and female participants must be 18 to 55 years of age, inclusive, at the time of
signing the informed consent document (ICD)

- Male and female participants who are healthy as determined by medical evaluation
including medical history, physical examination, including blood pressure (BP) and
pulse rate measurement, temperature, 12-lead ECG, and laboratory tests.

- Participants who are willing and able to comply with all scheduled visits, treatment
plan, laboratory tests, lifestyle considerations, and other study procedures.

- Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb).

- Capable of giving signed informed consent as described in the protocol, which includes
compliance with the requirements and restrictions listed in the informed consent
document (ICD) and in the protocol.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- Evidence or history of clinically significant hematological, renal, endocrine,
pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological,
dermatological, or allergic disease (including drug allergies, but excluding
untreated, asymptomatic, seasonal allergies at the time of dosing).

- Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy).

- Known immunodeficiency disorder, including positive serology for human
immunodeficiency virus (HIV) at screening, or a first degree relative with a
hereditary immunodeficiency.

- Infection with hepatitis B or hepatitis C viruses according to protocol-specific
testing algorithm.

- Participants with any of the protocol-listed acute or chronic infections or infection
history.

- History of febrile illness within 5 days prior to the first dose of investigational
product (in both Periods).

- History of any lymphoproliferative disorder such as Epstein Barr Virus (EBV) related
lymphoproliferative disorder, history of lymphoma, history of leukemia, or signs and
symptoms suggestive of current lymphatic or lymphoid disease.

- Participants have a known present or a history of malignancy other than a successfully
treated or excised non metastatic basal cell or squamous cell cancer of the skin or
cervical carcinoma in situ.

- Benign ethnic (cyclic) neutropenia.

- Having received any live (attenuated) vaccines within 6 weeks prior to the first dose
of investigational product.

- Other acute or chronic medical or psychiatric condition including recent (within the
past year) or active suicidal ideation or behavior or laboratory abnormality that may
increase the risk associated with study participation or investigational product
administration or may interfere with the interpretation of study results and, in the
judgment of the investigator, would make the participant inappropriate for entry into
this study.

- Use of prescription or nonprescription drugs and dietary and herbal supplements within
7 days or 5 half-lives (whichever is longer) prior to the first dose of
investigational product.

- Previous administration of an investigational drug within 30 days (or as determined by
the local requirement) or 5 half-lives (whichever is longer) preceding the first dose
of investigational product used in this study.

- Known participation in a clinical trial of PF-06650833 or PF-06651600.

- A positive urine drug test at screening or admission.

- Screening supine BP ?140 mm Hg (systolic) or ?90 mm Hg (diastolic), following at least
5 minutes of supine rest.

- Baseline 12-lead ECG that demonstrates clinically relevant abnormalities that may
affect participant safety or interpretation of study results.

- Participants with any of the protocol-listed abnormalities in clinical laboratory
tests at screening, as assessed by the study-specific laboratory and confirmed by a
single repeat test, if deemed necessary.

- Have evidence of untreated or inadequately treated active or latent Mycobacterium
tuberculosis (TB) infection.

- History of alcohol abuse or binge drinking and/or any other illicit drug use or
dependence within 6 months of Screening.

- Use of tobacco/nicotine containing products in excess of 5 cigarettes/day.

- Have a history of major organ transplant or hematopoietic stem cell/marrow transplant.
Skin grafts are allowed.

- Systemic therapy with any of the medications that are CYP3A4 inhibitors within 7 days
or 5 half-lives (whichever is longer) or CYP3A4 inducers within 28 days or 5
half-lives (whichever is longer) prior to the first dose of the trial medication.

- Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more
within 60 days prior to dosing.

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

- Unwilling or unable to comply with the Lifestyle Considerations criteria of the
protocol.

- Investigator site staff members directly involved in the conduct of the study and
their family members, site staff members otherwise supervised by the investigator, or
Pfizer employees, including their family members, directly involved in the conduct of
the study.

NCT03827668
Pfizer
Completed
A DRUG-DRUG INTERACTION STUDY BETWEEN PF-06650833 AND PF-06651600 FOLLOWING MULTIPLE DOSES IN HEALTHY PARTICIPANTS

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Pfizer Clinical Trials Contact Center

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[email protected]

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FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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[email protected]

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