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

Pfizer12 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

Drug: PF-07817883DRUG

PF-07817883 tablet

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Pfizer Clinical Research Unit - Brussels

Brussels, Bruxelles-capitale, Région de, Belgium

Outcomes

Primary Outcomes

Maximum Observed Plasma Concentration (Cmax) of PF-07817883

Time frame: 0, 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hours post-dose on Day 1 of each treatment period

Area Under the Concentration-time Curve From Time Zero (0) Extrapolated to Infinity (AUCinf) of PF-07817883

Time frame: 0, 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hours post-dose on Day 1 of each treatment period

Secondary Outcomes

Number of Participants With Treatment-emergent Adverse Events (TEAEs)

An adverse event (AE) was any untoward medical occurrence in a participant temporally associated with the use of study treatment, whether or not considered related to the study treatment. Treatment-emergent are events between first dose of study treatment and up to 28-35 days after last dose that were absent before treatment or that worsened relative to pretreatment state.

Time frame: From start of study treatment (Day 1) up to 28-35 days after last dose of study treatment (maximum up to 47 days)

Number of Participants With Laboratory Test Abnormalities

Laboratory parameters included hematology (eosinophils/leukocytes \[%\] greater than \[\>\] 1.2\*upper limit of normal), and urinalysis (urine hemoglobin and leukocyte esterase greater than or equal \[\>=\] to 1).

Time frame: From start of study treatment (Day 1) up to last dose of study treatment (maximum up to 12 days)

Number of Participants With Clinically Significant Abnormality in Vital Signs

Vital signs included diastolic blood pressure (DBP), systolic blood pressure (SBP) and pulse rate (PR) were measured in a supine position after approximately 5 minutes of rest for the participant. Criteria for vital signs included: SBP: value less than (\<) 90 millimeters of mercury (mmHg), change from baseline greater than or equal to (\>=) 30 mmHg increase, change from baseline \>=30 mmHg decrease; DBP: value \<50 mmHg, change from baseline \>=20 mmHg increase, change from baseline \>=20 mmHg decrease; PR: value \<40 beats per minute (bpm), value greater than (\>) 120 bpm.

Data from ClinicalTrials.gov

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