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

Phase 1

Completed

• Conditions: Healthy

• Registration Number: NCT06122194
• Lead Sponsor: Pfizer

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2023-10-10
• Study First Submitted QC: 2023-11-02
• Study First Posted: 2023-11-08
• Study Start: 2023-11-23
• Primary Completion: 2024-01-12
• Study Completion: 2024-01-12
• Status Verified: 2024-09
• Results First Submitted: 2024-12-23
• Results First Submitted QC: 2024-12-23
• Last Update Submitted: 2024-12-23
• Results First Posted: 2025-01-30
• Last Update Posted: 2025-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Area Under the Concentration-time Curve From Time Zero (0) Extrapolated to Infinity (AUCinf) of PF-07817883	0, 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hours post-dose on Day 1 of each treatment period
Maximum Observed Plasma Concentration (Cmax) of PF-07817883	0, 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hours post-dose on Day 1 of each treatment period

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Treatment-emergent Adverse Events (TEAEs)	From start of study treatment (Day 1) up to 28-35 days after last dose of study treatment (maximum up to 47 days)	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.
Number of Participants With Laboratory Test Abnormalities	From start of study treatment (Day 1) up to last dose of study treatment (maximum up to 12 days)	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).
Number of Participants With Clinically Significant Abnormality in Vital Signs	From start of study treatment (Day 1) up to last dose of study treatment (maximum up to 12 days)	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.
Number of Participants With Clinically Significant Abnormality in Electrocardiogram (ECG)	From start of study treatment (Day 1) up to last dose of study treatment (maximum up to 12 days)	Standard 12 lead ECGs were obtained with the participant in a supine position after at least 5 minutes of rest. Criteria were PR interval (\>=300 millisecond \[msec\], percent \[%\] change from baseline \>=25 to 50%), QRS duration (\>=140 msec, %change from baseline \>=50%), corrected QT interval using Fridericia's formula (QTcF) (\>500 msec, %change from baseline \>60 msec, 450 msec\<value less than equal to \[\<=\] 480 msec, 480 msec\<value\<=500 msec, 30 msec\<=change\<=60 msec).

Trial Locations

Locations (1)

Pfizer Clinical Research Unit - Brussels; 🇧🇪 Brussels, Bruxelles-capitale, Région DE, Belgium