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

NCT07721402 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: C45510172026-526038-26-00
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Participant

Keywords

Healthy Adults; Bioavailability; Pharmacokinetics; Absorption; Distribution; Metabolism; Elimination

Outcome Measures

Primary Outcomes (6)

• 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).

  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

  Cmax was the maximum observed plasma concentration directly observed from data.

  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)

  AUCinf was area under the plasma concentration time-curve from zero (pre-dose) extrapolated out to infinite time (If data permits).

  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

  Cmax was the maximum observed plasma concentration directly observed from data.

  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)

  AUCinf was area under the plasma concentration time-curve from zero (pre-dose) extrapolated out to infinite time (If data permits).

  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

  Cmax was the maximum observed plasma concentration directly observed from data.

  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 Outcomes (5)

• Number of Participants With Treatment Emergent Adverse Events (TEAEs)

  Up to Day 35 after the last dose of study intervention in Period 2

• Number of Participants with Clinically Significant Abnormalities in Laboratory Parameters

  Up to Day 35 after the last dose of study intervention in Period 2

• Number of Participants With Clinically Significant Abnormalities in Vital Signs

  Up to Day 35 after the last dose of study intervention in Period 2

• Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities

  Up to Day 35 after the last dose of study intervention in Period 2

• Number of Participants With Clinically Significant Physical Examination Abnormalities

  Up to Day 35 after the last dose of study intervention in Period 2

Study Arms (2)

Arm 1 prifetrastat

ACTIVE COMPARATOR

Crossover

Drug: prifetrastat Reference; Drug: prifetrastat Test 1

Arm 2 prifetrastat

ACTIVE COMPARATOR

Crossover

Drug: prifetrastat Reference; Drug: prifetrastat Test 2

Interventions

prifetrastat Reference DRUG

Reference Treatment

Arm 1 prifetrastat; Arm 2 prifetrastat

prifetrastat Test 1 DRUG

Test 1 Treatment

Arm 1 prifetrastat

prifetrastat Test 2 DRUG

Test 2 Treatment

Arm 2 prifetrastat

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Clinical Research Unit - Brussels

Brussels, Bruxelles-capitale, Région de, B-1070, Belgium

RECRUITING

Related Links

• To obtain contact information for a study center near you, click here.

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Central Study Contacts

Pfizer CT.gov Call Center

CONTACT

1-800-718-1021; ClinicalTrials.gov_Inquiries@pfizer.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2026
• First Posted: July 23, 2026
• Study Start: July 14, 2026
• Primary Completion (Estimated): December 8, 2026
• Study Completion (Estimated): December 8, 2026
• Last Updated: July 23, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)