Pfizer Clinical Research Unit - Brussels
Brussels, Bruxelles-capitale, Région de, B-1070, Belgium
NCT Number: NCT06122194
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 1
Brussels, Bruxelles-capitale, Région de, B-1070, Belgium
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
PF-07817883 tablet
Time frame: 0, 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hours post-dose on Day 1 of each treatment period
Time frame: 0, 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hours post-dose on Day 1 of each treatment period
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)
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 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).
Time frame: 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.
Time frame: 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).
Pfizer
Industry
A PHASE 1, OPEN-LABEL, RANDOMIZED, SINGLE DOSE, CROSSOVER STUDY TO ESTIMATE THE RELATIVE BIOAVAILABILITY OF PF-07817883 FOLLOWING ORAL ADMINISTRATION OF NEW FORMULATIONS RELATIVE TO THE REFERENCE FORMULATION IN HEALTHY ADULT PARTICIPANTS UNDER FASTED CONDITION
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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