A Study to Learn PF-07817883 Blood Levels After Administration of Tablets of Study Drug to Healthy Adult Volunteers

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Drug: PF-07817883

Study type: Interventional

Funder types: Industry

Identifiers

NCT06122194

2023-506442-24-00 (Registry Identifier)

C5091013

Details and patient eligibility

About

The purpose of this study is to estimate the oral bioavailability of 3 new formulations of PF-07817883 (test) relative to reference tablet formulation in healthy adult participants under fasted conditions. The study will also assess the safety and tolerability of test and reference tablet formulations in healthy adult participants.

Full description

This is a Phase 1, open-label, randomized, 4-period, 4-sequence crossover study in healthy adult participants evaluating the rBA of 3 new PF-07817883 test oral formulation(s) compared to PF-07817883 reference oral formulation. Approximately 12 participants will be enrolled in this study with approximately equal number of participants randomized to 1 of 4 sequences.

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Male and female participants aged 18 years or older, at screening who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and standard 12-lead ECG.
• BMI of 16 to 32 kg/m2; and a total body weight >45 kg
• Capable of giving signed informed consent.

Exclusion criteria

• Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior, laboratory abnormality, or other conditions and situations that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.

• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).

  1. Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy).
  2. History of HIV infection, hepatitis B, or hepatitis C; positive testing for HIV, HBsAg, or HCVAb. Hepatitis B vaccination is allowed.

• Positive test result for SARS-CoV-2 infection at admission

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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12 participants in 4 patient groups

Period 1 formulation 1 PF-07817883

Experimental group

Description:

Single oral dose of PF-07817883 tablet under fasted condition

Treatment:

Drug: Drug: PF-07817883

Period 2 formulation 2 PF-07817883

Experimental group

Description:

Single oral dose of PF-07817883 tablet under fasted condition

Treatment:

Drug: Drug: PF-07817883

Period 3 formulation 3 PF-07817883

Experimental group

Description:

Single oral dose of PF-07817883 tablet under fasted condition

Treatment:

Drug: Drug: PF-07817883

Period 4 formulation 4 PF-07817883

Experimental group

Description:

Single oral dose of PF-07817883 tablet under fasted condition

Treatment:

Drug: Drug: PF-07817883