The purpose of this study is to understand the relative amount of drug that enters bloodstream from prifetrastat product lots differing in active ingredient particle size distribution.
The study is seeking participants who are:
Healthy males and females of non-childbearing potential \>=18 years of age at screening
Participants in the study will receive a single dose of prifetrastat by mouth. After at least 14 days, they will receive another dose of prifetrastat by mouth. Each dose received by the patient will be in tablet form. The sequence in which tablets are given will be random.
The study will help understand how the difference in particle size distributions of the tablets may, or may not, affect how the drug is absorbed, processed, and eliminated by the body.
Participants will remain in the study clinic for 21 days. However, they may be permitted to leave between periods, and will have one follow-up contact.
Females of non-childbearing potential and males >=18 years of age at screening who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs and 12-lead ECGs.
BMI of 18-32 kilogram per meter square(Kg/m²); and a total body weight >50 kg (110 lb).
Use of prescription or nonprescription drugs and dietary and herbal supplements within 14 days or 5 half-lives (whichever is longer) prior to the first dose of study intervention
Prior use of epigenetic modifying agents. Participants will only be permitted to enroll in a single arm of this study (cannot participate in Arm 1 and Arm 2).
None
Crossover
prifetrastat Reference
DrugReference Treatment
prifetrastat Test 1
DrugTest 1 Treatment
prifetrastat Test 2
DrugTest 2 Treatment
Area under the Plasma Concentration-Time profile from time 0 to extrapolated infinite time (AUCinf) of Reference treatment of prifetrastat (AUClast If data does not permit AUCinf)
AUCinf was area under the plasma concentration time-curve from zero (pre-dose) extrapolated out to infinite time (If data permits).
Maximum Observed Plasma Concentration (Cmax) profile of Reference prifetrastat treatment
Cmax was the maximum observed plasma concentration directly observed from data.
Area under the Plasma Concentration-Time profile from time 0 to extrapolated infinite time (AUCinf) of Test 1 treatment of prifetrastat (AUClast If data does not permit AUCinf)
AUCinf was area under the plasma concentration time-curve from zero (pre-dose) extrapolated out to infinite time (If data permits).
Maximum Observed Plasma Concentration (Cmax) profile of Test 1 prifetrastat treatment
Cmax was the maximum observed plasma concentration directly observed from data.
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Number of Participants with Clinically Significant Abnormalities in Laboratory Parameters
Number of Participants With Clinically Significant Abnormalities in Vital Signs
Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities
