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Phase 1 PK Study to Evaluate the PK of CIN-107 in Subjects With Hepatic Impairment

CompletedPhase 1

Sponsor: AstraZeneca

Conditions: Hypertension

Interventions: baxdrostat

Countries: United States

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 overview

Sex: ALL

Age: 18 Years to 80 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

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 \<90 mmHg and/or diastolic BP \<50 mmHg, resting heart rate \>100 beats per minute (bpm) or \<50 bpm, Oral temperature \>37.6°C (\>99.68°F), Respiration rate \<12 or \>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

Locations (5)

Rialto, California, United States
Miami, Florida, United States
Orlando, Florida, United States
Knoxville, Tennessee, United States
San Antonio, Texas, United States