The purpose of the study is to learn how itraconazole changes how the body processes the study medicine called PF-07248144. The study will also look at the safety, tolerability, and how PF-07248144 is changed and removed from the body after taking PF-07248144 alone compared to when it is taken with itraconazole. Itraconazole can change how your body processes some medications so it may change the body's processing of PF-07248144. Multiple blood samples will be collected after each dose of PF-07248144 to determine how much PF-07248144 is in the blood at different times. This will help characterize the pharmacokinetics (pharmacokinetics helps us understand how the drug is changed and eliminated from your body after you take it) of PF-07248144 alone and when taken with itraconazole.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
12
Participants will receive PF-07248144 as a single dose, oral tablet on Day 1 of Period 1 and Day 4 of Period 2 with a washout period between two doses
Participants will receive Itraconazole oral solution once daily on Days 1-12 in Period 2
Pfizer Clinical Research Unit - New Haven
New Haven, Connecticut, United States
Area under the concentration-time curve from time zero to extrapolated infinite time (AUCinf) for PF-07248144
Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, and 216 hours post-dose
Area under the concentration-time curve from time zero to time of last measurable concentration (AUClast) for PF-07248144
AUClast will be used as the primary endpoint if AUCinf cannot be reliably estimated
Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, and 216 hours post-dose
Maximum observed plasma concentration (Cmax) for PF-07248144
Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, and 216 hours post-dose
Number of participants with treatment-emergent adverse events
Time frame: From baseline up to 28 to 35 days post last study intervention dose
Number of participants with laboratory test abnormalities
Time frame: From baseline up to 28 to 35 days post last study intervention dose
Number of participants with vital signs values meeting categorical summarization criteria
Time frame: From baseline up to 28 to 35 days post last study intervention dose
Number of participants with clinically significant physical examination abnormalities
Time frame: From baseline up to 28 to 35 days post last study intervention dose
Number of participants with treatment emergent clinically significant abnormal electrocardiogram (ECG) measurements
Time frame: From baseline up to 28 to 35 days post last study intervention dose
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