Heterozygous familial hypercholesterolemia, Heterozygous Familial Hypercholesterolemia
Conditions
Brief summary
Observed trough plasma concentration of ETC-1002 following 8 weeks of steady-state dosing of bempedoic acid, Model-based PK parameters including steady-state estimates of: −area under the plasma concentration-time curve (AUCss), −average plasma concentration (Cavg,ss) and −maximum plasma concentration (Cmax,ss)
Detailed description
Observed trough plasma concentration of ESP15228 (active metabolite) following 8 weeks of steady-state dosing of bempedoic acid, Plasma concentration at 4 hours (C4hr) of ETC-1002 and ESP15228 following first dose, ETC-1002 dose and exposure/LDL-C-lowering response relationship, Percent and absolute from baseline to Weeks 8 and 16 in LDL-C, TC, non-HDL-C, and hsCRP, Evaluation of acceptability (taste and ease of swallowing) of the age appropriate formulations
Interventions
DRUGBempedoic acid
DRUGbempedoic acid
Sponsors
Esperion Therapeutics Inc.
Eligibility
Sex/Gender
All
Age
0 Years to 17 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Observed trough plasma concentration of ETC-1002 following 8 weeks of steady-state dosing of bempedoic acid, Model-based PK parameters including steady-state estimates of: −area under the plasma concentration-time curve (AUCss), −average plasma concentration (Cavg,ss) and −maximum plasma concentration (Cmax,ss) | — |
Secondary
| Measure | Time frame |
|---|---|
| Observed trough plasma concentration of ESP15228 (active metabolite) following 8 weeks of steady-state dosing of bempedoic acid, Plasma concentration at 4 hours (C4hr) of ETC-1002 and ESP15228 following first dose, ETC-1002 dose and exposure/LDL-C-lowering response relationship, Percent and absolute from baseline to Weeks 8 and 16 in LDL-C, TC, non-HDL-C, and hsCRP, Evaluation of acceptability (taste and ease of swallowing) of the age appropriate formulations | — |
Countries
Denmark, Germany, Netherlands, Spain
Outcome results
None listed