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

Official title

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

Overview

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.

Interventions

• Drug prifetrastat Reference
  Reference Treatment
• Drug prifetrastat Test 1
  Test 1 Treatment
• Drug prifetrastat Test 2
  Test 2 Treatment

Primary outcome measures

• 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) [Time frame: 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 [Time frame: 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) [Time frame: 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 [Time frame: 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) [Time frame: 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 [Time frame: 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]

Secondary outcome measures (5)

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

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Crossover

Masking

Open label

Primary purpose

Basic science

Study locations

Belgium · 1 center

• Pfizer Clinical Research Unit - Brussels — Brussels

Identifiers

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

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗