PF-07081532
DrugPF-07081532 20 milligrams (mg), 1 tablet orally, once on Day 1
NCT Number: NCT05478603
The purpose of this study is to understand the effects of liver functional impairment on the study medicine (PF-07081532). People with liver functional impairment may process the study medicine differently from healthy people.
We are seeking participants who:
* Are between 18 and 70 years of age; * Have a BMI (body mass index) of 17.5 to 38.0 kg/m2, inclusive, and a total body weight >50 kg (110 lbs.).
Participants will take the study medicine as a tablet once at the study clinic, and then will stay onsite for about 7 days. During this time, the study team will monitor their treatment experience and take some blood samples to test the level of PF-07081532. This will help us understand if certain level of liver functional impairment could affect the study medicine being processed in the body.
Looking for future studies?
Notify Me18 year–70 year
All sexes
Interventional
Phase 1
Orlando Clinical Research Center, Orlando, Florida, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
PF-07081532 20 milligrams (mg), 1 tablet orally, once on Day 1
Time frame: At 0 (prior to dose), 0.5, 1, 2, 4, 6, 8, 10, 12, 15, 24, 36, 48, 72, 96, 120, and 144 hours post dose on Day 1
Cmax is the maximum plasma concentration.
Time frame: At 0 (prior to dose), 0.5, 1, 2, 4, 6, 8, 10, 12, 15, 24, 36, 48, 72, 96, 120, and 144 hours post dose on Day 1
AUCinf is the area under the plasma concentration-time profile from time zero extrapolated to infinite time.
Time frame: At 0 (prior to dose), 0.5, 1, 2, 4, 6, 8, 10, 12, 15, 24, 36, 48, 72, 96, 120, and 144 hours post dose on Day 1
AUClast is the area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration.
Time frame: At 0 (prior to dose), 0.5, 1, 2, 4, 6, 8, 10, 12, 15, 24, 36, 48, 72, 96, 120, and 144 hours post dose on Day 1
Fu is the fraction of unbound drug in plasma, which is calculated by Cu/C (where Cu represents unbound concentration and C represents total concentration).
Time frame: At 0 (prior to dose), 0.5, 1, 2, 4, 6, 8, 10, 12, 15, 24, 36, 48, 72, 96, 120, and 144 hours post dose on Day 1
Cmax,u is the unbound Cmax.
Time frame: At 0 (prior to dose), 0.5, 1, 2, 4, 6, 8, 10, 12, 15, 24, 36, 48, 72, 96, 120, and 144 hours post dose on Day 1
AUCinf,u is the unbound AUCinf.
Time frame: At 0 (prior to dose), 0.5, 1, 2, 4, 6, 8, 10, 12, 15, 24, 36, 48, 72, 96, 120, and 144 hours post dose on Day 1
AUClast,u is the unbound AUClast.
Time frame: Day 1 to Day 36
An adverse event (AE) was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A serious AE (SAE) was defined as any untoward medical occurrence that, at any dose: resulted in death; was life-threatening; required inpatient hospitalization/prolongation of existing hospitalization; resulted in persistent disability/incapacity; was a congenital anomaly/birth defect; or other serious situations such as important medical events. TEAEs were defined as events that started during the effective duration of treatment (ie, starting on or after the dose of PF-07081532 up to the final follow-up visit). AEs presented below were TEAEs. The investigator was required to use clinical judgment to assess the potential relationship between investigational product and each AE, to define an treatment-related AE.
Time frame: From baseline (BL) to Day 7
Safety laboratory assessments included clinical chemistry, hematology, and urinalysis tests. Number of participants with clinical laboratory abnormalities meeting pre-specified criteria is reported.
Time frame: From BL to Day 7
Vital signs abnormalities included: seated diastolic blood pressure (BP) increase and decrease from BL of >=20mmHg or absolute value <50mmHg; systolic BP increase and decrease from BL of >=30mmHg or absolute value <90mmHg; pulse rate <40 or >120bpm.
Time frame: From BL to Day 7
ECG assessments included PR interval, QT interval, QTcF, and QRS complex. ECG abnormalities included PR interval BL >200msec and max ≥25% increase from BL, or BL ≤200msec and max ≥50% increase from BL, or absolute value ≥300msec; QRS interval percent change from BL ≥50% or absolute value ≥140msec; QTcF change from BL 30- ≤60msec, >60msec, or absolute value 450- ≤480msec, 480- ≤500msec, or >500msec.
Pfizer
Industry
A PHASE 1, OPEN-LABEL, SINGLE-DOSE, PARALLEL GROUP STUDY TO COMPARE THE PHARMACOKINETICS OF PF-07081532 IN ADULT PARTICIPANTS WITH VARYING DEGREES OF HEPATIC IMPAIRMENT RELATIVE TO PARTICIPANTS WITHOUT HEPATIC IMPAIRMENT
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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