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A Study to Evaluate the Effect of Itraconazole on the Pharmacokinetics of PF-04958242 in Healthy Subjects

Last updated on March 14, 2019

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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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-Healthy male subjects and female subjects of non childbearing with a Body Mass Index (BMI)
of 17.5 to 30.5 kg/m2; and a total body weight >55 kg (121 lbs).

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- Subjects with ANY of the following abnormalities in clinical laboratory tests at
screening, as assessed by the study specific laboratory and confirmed by a single
repeat, if deemed necessary:

- Aspartate transaminase (AST)/serum glutamic oxaloacetic transminase (SGOT) or
alanine transaminase (ALT)/serum glutamic pyruvic transminase (SGPT) >=1 x upper
limit of normal (ULN);

- Total bilirubin >=1.5 x ULN; subjects with a history of Gilbert's syndrome may
have a direct bilirubin measured and would be eligible for this study provided
the direct bilirubin is

- Subjects with epilepsy, or history of epilepsy, or conditions that lower seizure
threshold, seizures of any etiology (including substance or drug withdrawal), or who
have increased risk of seizures as evidenced by self reported history of
electroencephalogram (EEG) with epileptiform activity. Subjects with a history of
childhood seizures and history of head trauma with loss of consciousness requiring
hospitalization overnight will be excluded as well.

- Subjects who had a history of allergy or intolerance to azole antifungal drugs.

NCT02341482
Pfizer
Completed
A Study to Evaluate the Effect of Itraconazole on the Pharmacokinetics of PF-04958242 in Healthy Subjects

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[email protected]

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