phase 1 pk study to evaluate the pk of cin-107 in subjects with hepatic impairment

Conditions: Hypertension

Summary: the goal of this phase 1, open-label, single-dose, parallel-group study is to evaluate the pharmacokinetics (pk) of a single 10-mg oral dose of baxdrostat in subjects with varying degrees of hepatic function. the main objectives are to: * to assess the safety and tolerability of baxdrostat following administration of a single oral dose of baxdrostat to subjects with varying degrees of hepatic function; and * to characterize the pk of baxdrostat following administration of a single oral dose of baxdrostat to subjects with varying degrees of hepatic function. participants were administered a single 10-mg oral dose of baxdrostat in the fasted state the morning of day 1. plasma samples were drawn at various timepoints. safety assessments included adverse events, vital signs, 12-lead electrocardiograms (ecgs), clinical laboratory evaluations, and physical examinations. twenty subjects in 2 groups based on the child-pugh classification in the protocol at screening: up to 10 subjects in the normal hepatic function group and up to 10 subjects in the moderate hepatic impairment group. twenty subjects entered and completed the study.


Eligibility criteria:
inclusion criteria: * is between the ages of 18 and 80 years, inclusive, and in stable health condition. (for hepatically impaired subjects, their hepatic function category must be stable for a minimum of 3 months prior to screening.) * is a non-nicotine user or smokes =\<10 cigarettes/day; * has a bmi between 18 and 42 kg/m2, inclusive; * is able to understand and willing to comply with study procedures and restrictions and provide written informed consent; * if a male subject with a female partner of childbearing potential must agree to use 2 medically accepted, highly effective methods of birth control for 90 days. * if male, must agree to abstain from sperm donation for 90 days; and * if female with a male partner, must be surgically sterile, postmenopausal, or agree to use 2 medically accepted, highly effective methods of birth control from day -14 until 60 days after study drug dosing main exclusion criteria: * personal or family history of long qt syndrome, torsades de pointes, or other complex ventricular arrhythmias, or family history of sudden death; * history of, or current, clinically significant arrhythmias; * prolonged qtcf (\>460 msec) based on the average of triplicate ecgs; * estimated glomerular filtration rate (or creatinine clearance) \<50 ml/min/1.73 m2; * evidence of any of the following: encephalopathy grade 2 or worse, seated systolic bp \>160 mmhg and/or diastolic bp \>100 mmhg, or systolic bp \ 100 beats per minute (bpm) or \ 37.6°c (\>99.68°f), respiration rate \ 20 breaths per minute, symptomatic postural tachycardia or orthostatic hypotension, abnormal serum potassium \>upper limit of normal range, abnormal serum sodium \<130 meq/l, positive test for hiv antibody, hepatitis c , hepatitis b , or sars-cov-2 rna * current treatment with weight loss medication or prior weight loss surgery; * use of a moderate or strong inhibitor of cyp3a4 within 14 days prior to the dose of study drug or use of a moderate or strong inducer of cyp3a4 within 28 days prior to the dose of study drug; * corticosteroid use (systemic or extensive topical use) within 3 months prior to study drug dosing * pregnant, breastfeeding, or planning to become pregnant during the study

Keywords: hepatic impairment pk baxdrostat