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The Study is to Evaluate the Effect of Multiple Doses PF-06751979 on the Pharmacokinetics of Midazolam in Healthy Adults

Last updated on March 14, 2019

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Study Location
Pfizer Clinical Research Unit
Brussels, , B-1070 Belgium
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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- Healthy female subjects of nonchildbearing potential and male subjects who, at the
time of screening, are 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 (BP) and pulse rate (PR)
measurement, 12-lead electrocardiogram (ECG), or clinical laboratory tests.

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

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, (including alcoholic liver
disease, nonalcoholic steatohepatitis (NASH), autoimmune hepatitis, and hereditary
liver diseases), psychiatric, neurological, 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).

- 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).

- Subjects who have previously received PF-06751979.

- Fertile male subjects 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 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.
As an exception, acetaminophen/paracetamol may be used at doses of use of nonprescription medications that are not believed to affect subject safety or
the overall results of the study may be permitted on a case-by-case basis following
approval by the sponsor.

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

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

- History of hypersensitivity to midazolam or any other benzodiazapine.

- 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 subject inappropriate for entry into this
study.

NCT03126721
Pfizer
Completed
The Study is to Evaluate the Effect of Multiple Doses PF-06751979 on the Pharmacokinetics of Midazolam in Healthy Adults

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