The purpose of the study is to assess the effect of food (high-fat, high-calorie meal) on the total and peak drug exposure of the planned to be marketed tablet formulation of prifetrastat. This study is seeking participants who are: \- Healthy males and females of nonchildbearing potential ≥18 years of age at screening The participants will receive study medicine prifetrastat as a single tablet by mouth at study clinic under fed or fasted condition. After at least 14 days, they will receive another single tablet of prifetrastat by mouth under fasted or fed condition. The sequence of conditions (fed or fasted first) will be randomized. The results of this study will enable data-driven guidance regarding food intake for participants enrolled in clinical studies of prifetrastat as well as patients receiving prifetrastat post-marketing. Participants will remain in clinic for about 21 days and have one follow up contact.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
12
Participants will receive Prifetrastat as a single dose, oral tablet on Day 1 of Period 1 and Day 1 of Period 2 with a washout period between two doses
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 Prifetrastat
Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, and 144 hours post-dose
Area under the concentration-time curve from time zero to time of last measurable concentration (AUClast) for Prifetrastat
Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, and 144 hours post-dose
Maximum observed plasma concentration (Cmax) for Prifetrastat
Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, and 144 hours post-dose
Number of participants with treatment-emergent adverse events
Time frame: Up to 28 to 35 days post last study intervention dose
Number of participants with laboratory test abnormalities
Time frame: Up to 28 to 35 days post last study intervention dose
Number of participants with vital signs values meeting categorical summarization criteria
Time frame: Up to 28 to 35 days post last study intervention dose
Number of participants with clinically significant physical examination abnormalities
Time frame: 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: Up to 28 to 35 days post last study intervention dose
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