The purpose of the current study is to characterize the pharmacokinetic (PK) profile of PF
04958242 when co administered with a strong cytochrome P450 3A4 (CYP3A4) inhibitor.
-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).
- 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 <= ULN.
- 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.