How different particle sizes of Prifetrastat affect how much medicine gets into the blood

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1 trial in healthy adults compares the bioavailability of prifetrastat tablets with varied particle size distributions. Participants receive a single oral dose, followed by a second dose after at least 14 days, in a randomized sequence. The study measures how absorption, distribution, and elimination may differ between tablet lots, using standard safety monitoring and laboratory assessments. Participants stay in the clinic for 21 days, with one follow-up contact after completion. The goal is to determine if particle size distribution affects drug exposure in the body.

Why it matters

Who can join: the full rules

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.

Where it's running

• Pfizer Clinical Research Unit - Brussels
  Brussels, Bruxelles-capitale, Région de, Belgium Recruiting

Study contacts

• Study coordinator: Pfizer CT.gov Call Center
• Email: ClinicalTrials.gov_Inquiries@pfizer.com
• Phone: 1-800-718-1021

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.