Multiple-dose study to measure pharmacokinetics, pharmacodynamics and safety of bempedoic acid in pediatric participants 6 to 17 years of age with HeFH.
Dose-selection based on body weight will be determined for use in pediatric clinical development.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
31
Once daily oral dosing with oral tablets.
Cedars-Sinai Medical Center
Los Angeles, California, United States
Plasma trough concentration of ETC-1002
Time frame: 8 weeks of steady-state dosing
Area under the plasma concentration-time curve (AUC,ss) of ETC-1002
Time frame: 8 weeks of steady-state dosing
Average plasma concentration (Cavg,ss) of ETC-1002
Time frame: 8 weeks of steady-state dosing
Maximum plasma concentration (Cmax,ss) of ETC-1002
Time frame: 8 weeks of steady-state dosing
Plasma trough concentration of ESP15228
Time frame: 8 weeks of steady-state dosing
Plasma concentration at 4 hours (C4hr) of ETC-1002
Time frame: Day 1
C4hr of ESP15228
Time frame: Day 1
Exposure/LDL-C response relationship
ETC-1002 dose and exposure/LDL-C-lowering response relationship
Time frame: 8 weeks of steady-state dosing
Percent change from Baseline in low-density lipoprotein cholesterol (LDL-C)
Time frame: Baseline and at Weeks 8 and 16
Absolute change from Baseline in LDL-C
Time frame: Baseline and at Weeks 8 and 16
Percent change from Baseline in non-high-density lipoprotein cholesterol (non-HDL-C)
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Providere Research Inc
West Covina, California, United States
Excel Medical Clinical Trials, LLC
Boca Raton, Florida, United States
Washington University School of Medicine, Division of Endocrinology, Metabolism and Lipid Research
St Louis, Missouri, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Cardiology Care for Children
Lancaster, Pennsylvania, United States
University of Utah and Primary Children's Hospital
Salt Lake City, Utah, United States
University of Alberta Hospital - Stollery Children's Hospital
Edmonton, Alberta, Canada
McMaster University Medical Center
Hamilton, Ontario, Canada
...and 14 more locations
Time frame: Baseline and at Weeks 8 and 16
Absolute change from Baseline in non-HDL-C
Time frame: Baseline and at Weeks 8 and 16
Percent change from Baseline in total cholesterol (TC)
Time frame: Baseline and at Weeks 8 and 16
Absolute change from Baseline in TC
Time frame: Baseline and at Weeks 8 and 16
Percent change from Baseline in high-sensitivity C-reactive protein (hsCRP)
Time frame: Baseline and at Weeks 8 and 16
Absolute change from Baseline in hsCRP
Time frame: Baseline and at Weeks 8 and 16
Acceptability of taste using a dosing acceptability questionnaire
Time frame: Up to Week 16
Acceptability of ease of swallowing using a dosing acceptability questionnaire
Time frame: Up to Week 16
Number of participants reporting Serious adverse events (SAEs) and non-SAEs
Time frame: Up to Week 16