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Completed

NCT Number: NCT07117799

A Study to Learn About How Different Forms of Study Medicine PF-07248144 Are Taken Up Into the Blood in Healthy Adults

Study has two arms. Arm 1 has two cohorts in which each cohort, under the fasted state, will either be given a single oral dose of Form 1 in Period 1 followed by a single oral dose of Form 5 in Period 2 or a single oral dose of Form 5 in Period 1 followed by a single oral dose of Form 1 in Period 2. A single oral dose of Form 1 will be administered in Arm 2 Period 1 under the fasted state. The results from Arm 1 will inform whether a different dose of Form 5 will be administered under the fasted state or if Form 5 will be administered under the fed state in Arm 2 Period 2.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Clinical Research Unit - New Haven

New Haven, Connecticut, 06511, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants of nonchildbearing potential , inclusive, at screening, who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs, and 12-lead electrocardiograms (ECGs).
  • Body mass index (BMI) of 18-32 kg/m2; and a total body weight >50 kg (110 lb)

Exclusion criteria

  • 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
  • Current use of any prohibited concomitant medication(s) or unwillingness or inability to use a required concomitant medication(s)
  • Additionally, 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 or 5 half-live 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 PF-07248144
  • Proton pump inhibitors must be discontinued at least 5 days prior to the first dose of study medication and throughout treatment period.

Treatment and study plan

PF-07248144

Drug

Period 1: Participants received Form 1 in a single dose of tablet fasted Period 2: Participants received Form 5 in a single dose of tablet fasted

Primary outcomes

  1. Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for PF-07248144 Form 1 uncoated tablet

    Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, and 168 hours post-dose

  2. AUCinf for PF-07248144 Form 5 film-coated tablet

    Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, and 168 hours post-dose

  3. Maximum Observed Plasma Concentration (Cmax) for PF-07248144 Form 1 uncoated tablet

    Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, and 168 hours post-dose

  4. Cmax for PF-07248144 Form 5 film-coated tablet

    Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, and 168 hours post-dose

Secondary outcomes

  1. Number of Participants With Treatment Emergent Treatment Related AEs and SAEs

    Time frame: From Baseline up to Day 35

  2. Number of Participants With Laboratory Test Abnormalities

    Time frame: From Baseline up to Day 35

  3. Number of Participants With Vital Signs Values Meeting Categorical Summarization Criteria

    Time frame: From Baseline up to Day 35

  4. Number of Participants With Clinically Significant Physical Examination Abnormalities

    Time frame: From Baseline up to Day 35

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A PHASE 1, RANDOMIZED, OPEN-LABEL, 2 ARM, 2-PERIOD, CROSS-OVER, SINGLE-DOSE STUDY IN HEALTHY PARTICIPANTS TO INVESTIGATE THE RELATIVE BIOAVAILABILITY OF TWO PF-07248144 CLINICAL TRIAL FORMULATIONS

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Aug 12, 2025
Registry last updated
Dec 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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