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

NCT07117799 | Completed Phase 1 FDA Drug

• 1 other identifier: C4551005
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Adults

Keywords

Bioavailability; Bioequivalent

Outcome Measures

Primary Outcomes (4)

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

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

• AUCinf for PF-07248144 Form 5 film-coated tablet

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

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

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

• Cmax for PF-07248144 Form 5 film-coated tablet

  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 (4)

• Number of Participants With Treatment Emergent Treatment Related AEs and SAEs

  From Baseline up to Day 35

• Number of Participants With Laboratory Test Abnormalities

  From Baseline up to Day 35

• Number of Participants With Vital Signs Values Meeting Categorical Summarization Criteria

  From Baseline up to Day 35

• Number of Participants With Clinically Significant Physical Examination Abnormalities

  From Baseline up to Day 35

Study Arms (3)

PF-07248144 Form 1 (uncoated) Arm

EXPERIMENTAL

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

Drug: PF-07248144

PF-07248144 Form 5 (film-coated) Arm

EXPERIMENTAL

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

Drug: PF-07248144

PF-07248144 Form 5 (film-coated) Adaptive Arm

EXPERIMENTAL

Period 1: Fasted participants received a single dose of tablet of Form 1 orally Period 2: Participants received a single dose of tablet orally of Form 5 in a fed state

Drug: PF-07248144

Interventions

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

PF-07248144 Form 1 (uncoated) Arm; PF-07248144 Form 5 (film-coated) Adaptive Arm; PF-07248144 Form 5 (film-coated) Arm

Eligibility Criteria

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

You may qualify if:

• 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)

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
• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Clinical Research Unit - New Haven

New Haven, Connecticut, 06511, United States

Location

Related Links

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

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

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: August 5, 2025
• First Posted: August 12, 2025
• Study Start: February 4, 2025
• Primary Completion: June 18, 2025
• Study Completion: July 11, 2025
• Last Updated: December 1, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)