PF-06882961 20MG
DrugPF-06882961 in 20 mg oral tablet will be administered on Day 1
NCT Number: NCT04604496
The current study is proposed to evaluate whether there is any clinically meaningful effect of hepatic impairment on the plasma Pharmacokinetic (PK) of PF-06882961
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Notify Me18 year–70 year
All sexes
Interventional
Phase 1
University of Miami Division of Clinical Pharmacology, Miami, Florida, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
HbA1c ≥6.5%; FPG ≥126 mg/Dl; eGFR<60 mL/min/1.73m2;
PF-06882961 in 20 mg oral tablet will be administered on Day 1
Time frame: Predose (0 hours), 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 36 and 48 hours post dose on Day 1.
Maximum observed plasma PF-06882961 concentration.
Time frame: Predose (0 hours), 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 36 and 48 hours post dose on Day 1.
Area under the plasma PF-06882961 concentration-time profile from time 0 extrapolated to infinite time.
Time frame: Predose (0 hours), 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 36 and 48 hours post dose on Day 1.
Area under the plasma PF-06882961 concentration-time profile from time 0 extrapolated to the time of the last quantifiable concentration.
Time frame: Predose (0 hours), and 4 hours post dose on Day 1.
fu = Cu/C (where Cu represents unbound concentration and C represents total concentration).
Time frame: Baseline to Day 30
Adverse events (AEs): any untoward medical occurrence in a clinical investigation participant administered a product or medical device, without regard to causality. Treatment-emergent AEs (TEAEs): AEs which occurred for the first time during the effective duration of treatment or AEs that increased in severity during treatment. AEs included SAEs and non-serious AEs. Serious AEs (SAEs) were any untoward medical occurrence at any dose that resulted in death; was life-threatening; required inpatient hospitalization or caused prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduction normal life functions). Treatment-related TEAEs were any untoward medical occurrence attributed to study treatment. Relatedness to study treatment was determined by the investigator.
Time frame: Baseline to Day 3
Protocol-required safety laboratory assessments included: hemoglobin <0.8 x lower limit of normal (LLN), hematocrit <0.8 x LLN, erythrocytes <0.8 x LLN, ery. mean corpuscular volume >1.1 x upper limit of normal (ULN), ery. mean corpuscular hemoglobin >1.1 x ULN, platelets <0.5 x LLN, eosinophils >1.2 x ULN, activated partial thromboplastin time >1.1 x ULN, prothrombin time >1.1 x ULN, prothrombin intl. normalized ratio >1.1 x ULN; bilirubin/direct bilirubin/indirect bilirubin >1.5 x ULN, aspartate aminotransferase/alanine aminotransferase/gamma glutamyl transferase >3.0 x ULN, albumin <0.8 x LLN, urate >1.2 x ULN, bicarbonate >1.1 x ULN, triacylglycerol lipase >1.5 x ULN; urine hemoglobin/urine urobilinogen/urine nitrite/urine leukocyte esterase ≥1.
Time frame: Baseline to Day 3
Vital signs categorical criteria: 1) supine systolic blood pressure (SBP) <90 millimeters of mercury (mmHg); 2) supine diastolic blood pressure (DBP) <50 mmHg; 3) supine pulse rate <40 or >120 beats per minute (bpm); 4) change from baseline (increase or decrease) in supine SBP greater than or equal to (≥) 30 mmHg; 5) change from baseline (increase or decrease) in supine DBP ≥ 20 mmHg.
Time frame: Baseline to Day 3
ECG categorical criteria: 1. PR interval (the interval between the start of the P wave and the start of the QRS complex, corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization): a) greater than or equal to (≥) 300 millisecond (msec), b) ≥25% increase when baseline is > 200 msec or ≥50% increase when baseline is less than or equal to (≤) 200 msec.
Pfizer
Industry
A Phase 1, Non-randomized, Open-label, Single-dose, Parallel Cohort Study to Compare the Pharmacokinetics of PF-06882961 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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