A Study to Learn About How Different Forms of Study Medicine Prifetrastat Are Taken Up Into the Blood in Healthy Adults

Официальное название

A PHASE 1, RANDOMIZED, OPEN-LABEL, 2-PERIOD, 4-SEQUENCE SINGLE-DOSE CROSSOVER STUDY IN HEALTHY PARTICIPANTS TO INVESTIGATE THE RELATIVE BIOAVAILABILITY OF PRIFETRISTAT DRUG PRODUCT DIFFERING IN PARTICLE SIZE DISTRIBUTION

Обзор

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.

Вмешательства

• Препарат prifetrastat Reference
  Reference Treatment
• Препарат prifetrastat Test 1
  Test 1 Treatment
• Препарат prifetrastat Test 2
  Test 2 Treatment

Первичные конечные точки

• 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) [Срок оценки: Pre-dose, 0, 0.5, 1, 1.5, 2, 3, 4 ,6 , 8, 12, 24, 36, 48, 72, 96, 144 hours post dose in period 1 and period 2]
• Maximum Observed Plasma Concentration (Cmax) profile of Reference prifetrastat treatment [Срок оценки: Pre-dose, 0, 0.5, 1, 1.5, 2, 3, 4 ,6 , 8, 12, 24, 36, 48, 72, 96, 144 hours post dose in period 1 and period 2]
• 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) [Срок оценки: Pre-dose, 0, 0.5, 1, 1.5, 2, 3, 4 ,6 , 8, 12, 24, 36, 48, 72, 96, 144 hours post dose in period 1 and period 2]
• Maximum Observed Plasma Concentration (Cmax) profile of Test 1 prifetrastat treatment [Срок оценки: Pre-dose, 0, 0.5, 1, 1.5, 2, 3, 4 ,6 , 8, 12, 24, 36, 48, 72, 96, 144 hours post dose in period 1 and period 2]
• Area under the Plasma Concentration-Time profile from time 0 to extrapolated infinite time (AUCinf) of Test 2 treatment of prifetrastat (AUClast If data does not permit AUCinf) [Срок оценки: Pre-dose, 0, 0.5, 1, 1.5, 2, 3, 4 ,6 , 8, 12, 24, 36, 48, 72, 96, 144 hours post dose in period 1 and period 2]
• Maximum Observed Plasma Concentration (Cmax) profile of Test 2 prifetrastat treatment [Срок оценки: Pre-dose, 0, 0.5, 1, 1.5, 2, 3, 4 ,6 , 8, 12, 24, 36, 48, 72, 96, 144 hours post dose in period 1 and period 2]

Вторичные конечные точки (5)

• Number of Participants With Treatment Emergent Adverse Events (TEAEs) [Срок оценки: Up to Day 35 after the last dose of study intervention in Period 2]
• Number of Participants with Clinically Significant Abnormalities in Laboratory Parameters [Срок оценки: Up to Day 35 after the last dose of study intervention in Period 2]
• Number of Participants With Clinically Significant Abnormalities in Vital Signs [Срок оценки: Up to Day 35 after the last dose of study intervention in Period 2]
• Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities [Срок оценки: Up to Day 35 after the last dose of study intervention in Period 2]
• Number of Participants With Clinically Significant Physical Examination Abnormalities [Срок оценки: Up to Day 35 after the last dose of study intervention in Period 2]

Критерии участия

Inclusion

• 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/m\^2); and a total body weight >50 kg (110 lb).

Exclusion

• 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).
• Current use of any prohibited concomitant medication(s) or unwillingness or inability to use a required concomitant medication(s).
• current use or anticipated need for food or drugs that are known strong inducers or inhibitors of CYP2C9 or CYP3A4, including their administration within 14 days plus 5 half-lives of the strong inducers or inhibitors of CYP2C9 or CYP3A4, whichever is longer, prior to first dose of study intervention, during the treatment period, and within 2 days after the last dose of prifetrastat
• Proton pump inhibitors must be discontinued at least 14 days prior to the first dose of study medication and throughout treatment period.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Открытое

Основная цель

Фундаментальное исследование

Центры проведения

Бельгия · 1 центр

• Pfizer Clinical Research Unit - Brussels — Brussels

Идентификаторы

NCT: NCT07721402 · C4551017 · 2026-526038-26-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗