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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy Adults

Treatments: Drug: PF-07248144

Study type: Interventional

Funder types: Industry

Identifiers

NCT07117799

C4551005

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 3 patient groups

PF-07248144 Form 1 (uncoated) Arm

Experimental group

Description:

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

Treatment:

Drug: PF-07248144

Drug: PF-07248144

Drug: PF-07248144

PF-07248144 Form 5 (film-coated) Arm

Experimental group

Description:

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

Treatment:

Drug: PF-07248144

Drug: PF-07248144

Drug: PF-07248144

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

Experimental group

Description:

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

Treatment:

Drug: PF-07248144

Drug: PF-07248144

Drug: PF-07248144