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PK Study in Adult Healthy Volunteers to Assess QD Dosing With the Selected Age-appropriate MR Formulations

Last updated on March 15, 2019

Study Location
Pfizer New Haven Clinical Research Unit
New Haven, Connecticut, 06511 United States
Eligibility criteria
The disease, disorder, syndrome, illness, or injury that is being studied.
Females and Males
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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- Healthy male and or female subjects of non-childbearing potential between the ages of
18 and 55 years, inclusive.

- Female subjects of nonchildbearing potential must meet at least 1 of the following

1. Achieved postmenopausal status, defined as: cessation of regular menses for at
least 12 consecutive months with no alternative pathological or physiological
cause; and have a serum follicle stimulating hormone (FSH) level confirming the
postmenopausal state;

2. Have undergone a documented hysterectomy and/or bilateral oophorectomy;

3. Have medically confirmed ovarian failure. All other female subjects (including
female subjects with tubal ligations) are considered to be of childbearing

- Body Mass Index (BMI) of 17.5 to 30.5 kg per m2; and a total body weight above 50 kg
(110 lbs) for males and above 45 kg (99 lbs) for females.

- No evidence of active or latent or inadequately treated infection with Mycobacterium
tuberculosis (TB)

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, neurologic, or
allergic disease (including drug allergies, but excluding untreated, asymptomatic,
seasonal allergies at the time of dosing).

- Clinically significant infections within the past 3 months, evidence of any infection
within the past 7 days, history of disseminated herpes simplex infection or recurrent
(>1 episode) herpes zoster or disseminated herpes zoster.

- Absolute lymphocyte count at Screening or Baseline less than the lower limit of the
reference range for the local laboratory

- Evidence or history of cyclic neutropenia.

- Personal or family history of hereditary immunodeficiency

- Vaccination with live or attenuated vaccines within the 6 weeks of dosing, or is to be
vaccinated with these vaccines at any time during study treatment or within 6 weeks
following discontinuation of dosing.

- Any condition possibly affecting drug absorption (eg, gastrectomy, colon resection,

- History of, or current positive results for any of the following serological tests:
human immunodeficiency virus (HIV), hepatitis B, or hepatitis C;

- Malignancy or a history of malignancy, with the exception of adequately treated or
excised non-metastatic basal cell or squamous cell cancer of the skin or cervical
carcinoma in situ.

- Positive urine drug test.

- History of regular alcohol consumption

- Use of tobacco- or nicotine-containing products in excess of the equivalent of 5
cigarettes per day.

- Treatment with an investigational drug within 30 days (or as determined by the local
requirement ) or 5 half-lives preceding the first dose of investigational product
(whichever is longer).

- Nursing females or females of childbearing potential. Male subjects who are unwilling
or unable to use a condom plus a highly effective method of contraception as outlined
in this protocol for the duration of the study and for at least 28 days after the last
dose of investigational product.

- 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.

Herbal supplements and hormone replacement therapy must be discontinued at least 28 days
prior to the first dose of investigational product.

- Use of CYP3A4 inhibitors or inducers within 14 days or 5 half-lives (whichever is
longer) prior to dosing.

- Consumption of grapefruit or grapefruit-related citrus fruits (eg, Seville oranges,
pomelos) or juices within 7 days prior to dosing.

- 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.

PK Study in Adult Healthy Volunteers to Assess QD Dosing With the Selected Age-appropriate MR Formulations


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