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Single Dose Study Of The Effect Of Cyclosporine On The Pharmacokinetics Of PF-04991532 In Health Volunteers

Last updated on March 14, 2019

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Study Location
Pfizer Investigational Site
Bruxelles, , B-1070 Belgium
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy, Drug Interaction
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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- Healthy male and/or female (non-childbearing potential) subjects between the ages of
18 and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities
identified by a detailed medical history, full physical examination, including blood
pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests. Women
must be of non childbearing potential as defined in Lifestyle Guidelines. Body Mass
Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).

- An informed consent document signed and dated by the subject or a legally acceptable
representative.

- Subjects who are 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.
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- Evidence or history of clinically significant hematological, renal, endocrine,
pulmonary, gastrointestinal, cardiovascular, hepatic, sychiatric, neurologic, or
allergic (including drug allergies, but excluding untreated, asymptomatic, seasonal
allergies at time of dosing) disease or clinical findings at Screening.

- Subjects with clinically significant infections within the past 3 months (for example,
those requiring hospitalization, or as judged by the Investigator), or evidence of any
infection within the past 7 days.

- Screening supine blood pressure >=140 mm Hg (systolic) or >=90 mm Hg (diastolic), on a
single measurement [confirmed by a single repeat, if necessary] following at least 5
minutes of rest.

NCT01370343
Pfizer
Completed
Single Dose Study Of The Effect Of Cyclosporine On The Pharmacokinetics Of PF-04991532 In Health Volunteers

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[email protected]

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