Trial Outcomes & Findings for Milk-Only Lactation Study to Evaluate the Concentration of Bempedoic Acid and Bempedoic Acid/Ezetimibe Fixed Combination Drug Product (FCDP) in the Breast Milk of Healthy Lactating Women (NCT NCT06021951)
NCT ID: NCT06021951
Last Updated: 2025-04-11
Results Overview
Daily infant dosage of study drug was calculated for Bempedoic Acid arm and FCDP arm respectively from the cumulative amount of study drug (bempedoic acid or bempedoic acid and ezetimibe) excreted in breast milk over 24 hours.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
16 participants
Primary outcome timeframe
24 hours post Day 6 dose administration
Results posted on
2025-04-11
Participant Flow
This was a Phase 4, open-label study that estimated the daily infant dosage and relative infant dose (RID) for bempedoic acid and bempedoic acid/ezetimibe fixed combination drug product (FCDP) and characterized the excretion of bempedoic acid (ETC-1002), ezetimibe, and metabolites ESP-15228, ETC-1002-glucuronide, and ezetimibe-glucuronide in the mature breast milk of healthy women.
A total of 16 subjects were enrolled into the study and randomized in a 1:1 ratio to receive bempedoic acid 180 milligrams (mg) or bempedoic acid 180 mg/ezetimibe 10 mg FCDP
Participant milestones
| Measure |
Bempedoic Acid
Participants received bempedoic acid 180 mg oral tablet for 6 days
|
Bempedoic Acid/Ezetimibe FCDP
Participants received bempedoic acid 180 mg/ezetimibe 10 mg FCDP oral tablets for 6 days
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
|
Overall Study
COMPLETED
|
8
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Milk-Only Lactation Study to Evaluate the Concentration of Bempedoic Acid and Bempedoic Acid/Ezetimibe Fixed Combination Drug Product (FCDP) in the Breast Milk of Healthy Lactating Women
Baseline characteristics by cohort
| Measure |
Bempedoic Acid
n=8 Participants
Participants received bempedoic acid 180 mg oral tablet for 6 days
|
Bempedoic Acid/Ezetimibe FCDP
n=8 Participants
Participants received bempedoic acid 180 mg/ezetimibe 10 mg FCDP oral tablets for 6 days
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
33.5 Years
STANDARD_DEVIATION 4.17 • n=5 Participants
|
27.1 Years
STANDARD_DEVIATION 4.09 • n=7 Participants
|
30.3 Years
STANDARD_DEVIATION 5.17 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 hours post Day 6 dose administrationPopulation: Pharmacokinetic Analysis Set comprised of all participants in Full Analysis Set who had at least 1 evaluable post-dosing breast milk bempedoic acid pharmacokinetic concentration data point.
Daily infant dosage of study drug was calculated for Bempedoic Acid arm and FCDP arm respectively from the cumulative amount of study drug (bempedoic acid or bempedoic acid and ezetimibe) excreted in breast milk over 24 hours.
Outcome measures
| Measure |
Bempedoic Acid
n=8 Participants
Bempedoic Acid Arm
|
Bempedoic Acid (FCDP)
n=8 Participants
Bempedoic Acid / Ezetimibe FCDP Arm
|
Ezetimibe (FCDP)
n=8 Participants
Bempedoic Acid / Ezetimibe FCDP Arm
|
ETC-1002 (FCDP)
Bempedoic Acid / Ezetimibe FCDP Arm
|
ESP-15228 (FCDP)
Bempedoic Acid / Ezetimibe FCDP Arm
|
ETC-1002-Glucuronide (FCDP)
Bempedoic Acid / Ezetimibe FCDP Arm
|
|---|---|---|---|---|---|---|
|
Daily Infant Dose
|
0.0331 Milligrams per day
Standard Deviation 0.0210
|
0.0337 Milligrams per day
Standard Deviation 0.0286
|
0.0002 Milligrams per day
Standard Deviation 0.0002
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 24 hours post Day 6 dose administrationPopulation: Pharmacokinetic Analysis Set.
Relevant Infant Dose (RID) (calculated as the ratio of estimated infant daily dose per kg body weight and maternal daily dose per kg of body weight multiplied by 100) was analyzed for the Bempedoic Acid arm and FCDP arm respectively. Maternal dosage is the ratio of bempedoic acid dose or ezetimibe dose administered daily divided by maternal body weight at baseline.
Outcome measures
| Measure |
Bempedoic Acid
n=8 Participants
Bempedoic Acid Arm
|
Bempedoic Acid (FCDP)
n=8 Participants
Bempedoic Acid / Ezetimibe FCDP Arm
|
Ezetimibe (FCDP)
n=8 Participants
Bempedoic Acid / Ezetimibe FCDP Arm
|
ETC-1002 (FCDP)
Bempedoic Acid / Ezetimibe FCDP Arm
|
ESP-15228 (FCDP)
Bempedoic Acid / Ezetimibe FCDP Arm
|
ETC-1002-Glucuronide (FCDP)
Bempedoic Acid / Ezetimibe FCDP Arm
|
|---|---|---|---|---|---|---|
|
Relative Infant Dose (RID)
|
0.4790 Percentage of maternal dose
Standard Deviation 0.1962
|
0.4678 Percentage of maternal dose
Standard Deviation 0.2889
|
0.0370 Percentage of maternal dose
Standard Deviation 0.0097
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 24 hours post Day 6 dose administrationPopulation: Pharmacokinetic Analysis Set. Only those participants with data available at specified time points has been presented.
Cumulative amount of ETC-1002, ESP-15228, and ETC-1002-glucuronide excreted in breast milk during the 24-hour collection period were analyzed for the Bempedoic Acid arm and FCDP arm respectively.
Outcome measures
| Measure |
Bempedoic Acid
n=8 Participants
Bempedoic Acid Arm
|
Bempedoic Acid (FCDP)
n=1 Participants
Bempedoic Acid / Ezetimibe FCDP Arm
|
Ezetimibe (FCDP)
n=8 Participants
Bempedoic Acid / Ezetimibe FCDP Arm
|
ETC-1002 (FCDP)
n=8 Participants
Bempedoic Acid / Ezetimibe FCDP Arm
|
ESP-15228 (FCDP)
n=1 Participants
Bempedoic Acid / Ezetimibe FCDP Arm
|
ETC-1002-Glucuronide (FCDP)
n=8 Participants
Bempedoic Acid / Ezetimibe FCDP Arm
|
|---|---|---|---|---|---|---|
|
Cumulative Amount of Bempedoic Acid (ETC-1002) and Metabolites (ESP-15228, ETC-1002-Glucuronide) in Breast Milk
|
33120.0 Nanograms
Standard Deviation 21034.11
|
14207.4 Nanograms
Standard Deviation NA
Not applicable (NA) due to 7 out of 8 participants had ESP-15228 concentration below the lower limit of quantification (BLQ) (\<20.0) at all nominal timepoints.
|
20690.5 Nanograms
Standard Deviation 6554.48
|
33673.4 Nanograms
Standard Deviation 28635.66
|
770.0 Nanograms
Standard Deviation NA
Not applicable (NA) due to 7 out of 8 participants had ESP-15228 concentration below the lower limit of quantification (BLQ) (\<20.0) at all nominal timepoints.
|
20709.1 Nanograms
Standard Deviation 16012.78
|
SECONDARY outcome
Timeframe: 24 hours post Day 6 dose administrationPopulation: Pharmacokinetic Analysis Set. Only those participants with data available at specified time points has been presented.
Cumulative amount of Ezetimibe, and EZE-glucuronide excreted in breast milk during 24-hour collection period were analyzed (FCDP arm only).
Outcome measures
| Measure |
Bempedoic Acid
n=8 Participants
Bempedoic Acid Arm
|
Bempedoic Acid (FCDP)
n=8 Participants
Bempedoic Acid / Ezetimibe FCDP Arm
|
Ezetimibe (FCDP)
Bempedoic Acid / Ezetimibe FCDP Arm
|
ETC-1002 (FCDP)
Bempedoic Acid / Ezetimibe FCDP Arm
|
ESP-15228 (FCDP)
Bempedoic Acid / Ezetimibe FCDP Arm
|
ETC-1002-Glucuronide (FCDP)
Bempedoic Acid / Ezetimibe FCDP Arm
|
|---|---|---|---|---|---|---|
|
Cumulative Amount of Ezetimibe (EZE) and Metabolite (EZE-Glucuronide) in Breast Milk
|
182.2 Nanograms
Standard Deviation 154.97
|
983.0 Nanograms
Standard Deviation 996.16
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 24 hours post Day 6 dose administrationPopulation: Pharmacokinetic Analysis Set. Only those participants with data available at specified time points has been presented.
Cmax of ETC-1002, ESP-15228, and ETC-1002-glucuronide in Breast Milk were analyzed for Bempedoic Acid arm and FCDP arm respectively
Outcome measures
| Measure |
Bempedoic Acid
n=8 Participants
Bempedoic Acid Arm
|
Bempedoic Acid (FCDP)
n=1 Participants
Bempedoic Acid / Ezetimibe FCDP Arm
|
Ezetimibe (FCDP)
n=8 Participants
Bempedoic Acid / Ezetimibe FCDP Arm
|
ETC-1002 (FCDP)
n=8 Participants
Bempedoic Acid / Ezetimibe FCDP Arm
|
ESP-15228 (FCDP)
n=1 Participants
Bempedoic Acid / Ezetimibe FCDP Arm
|
ETC-1002-Glucuronide (FCDP)
n=8 Participants
Bempedoic Acid / Ezetimibe FCDP Arm
|
|---|---|---|---|---|---|---|
|
Maximum Concentrations (Cmax) of Bempedoic Acid and Metabolites in Breast Milk
|
118.15 Nanograms per milliliter
Geometric Coefficient of Variation 38.91
|
NA Nanograms per milliliter
Geometric Coefficient of Variation NA
Not applicable (NA) due to 7 out of 8 participants had ESP-15228 concentration below the lower limit of quantification (BLQ) (\<20.0) at all nominal timepoints.
|
73.06 Nanograms per milliliter
Geometric Coefficient of Variation 56.59
|
107.46 Nanograms per milliliter
Geometric Coefficient of Variation 43.19
|
NA Nanograms per milliliter
Geometric Coefficient of Variation NA
Not applicable (NA) due to 7 out of 8 participants had ESP-15228 concentration below the lower limit of quantification (BLQ) (\<20.0) at all nominal timepoints.
|
57.29 Nanograms per milliliter
Geometric Coefficient of Variation 56.35
|
SECONDARY outcome
Timeframe: 24 hours post Day 6 dose administrationPopulation: Pharmacokinetic Analysis Set.
Cmax of Ezetimibe, and EZE-glucuronide analyzed in FCDP arm only.
Outcome measures
| Measure |
Bempedoic Acid
n=8 Participants
Bempedoic Acid Arm
|
Bempedoic Acid (FCDP)
n=8 Participants
Bempedoic Acid / Ezetimibe FCDP Arm
|
Ezetimibe (FCDP)
Bempedoic Acid / Ezetimibe FCDP Arm
|
ETC-1002 (FCDP)
Bempedoic Acid / Ezetimibe FCDP Arm
|
ESP-15228 (FCDP)
Bempedoic Acid / Ezetimibe FCDP Arm
|
ETC-1002-Glucuronide (FCDP)
Bempedoic Acid / Ezetimibe FCDP Arm
|
|---|---|---|---|---|---|---|
|
Cmax of Ezetimibe and Metabolite in Breast Milk
|
0.63 Nanograms per milliliter
Geometric Coefficient of Variation 44.29
|
2.93 Nanograms per milliliter
Geometric Coefficient of Variation 54.02
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 24 hours post Day 6 dose administrationPopulation: Pharmacokinetic Analysis Set. Only those participants with data available at specified time points has been presented.
Tmax of ETC-1002, ESP-15228, and ETC-1002-glucuronide in Breast Milk were analyzed for Bempedoic Acid arm and FCDP arm respectively
Outcome measures
| Measure |
Bempedoic Acid
n=8 Participants
Bempedoic Acid Arm
|
Bempedoic Acid (FCDP)
n=1 Participants
Bempedoic Acid / Ezetimibe FCDP Arm
|
Ezetimibe (FCDP)
n=8 Participants
Bempedoic Acid / Ezetimibe FCDP Arm
|
ETC-1002 (FCDP)
n=8 Participants
Bempedoic Acid / Ezetimibe FCDP Arm
|
ESP-15228 (FCDP)
n=1 Participants
Bempedoic Acid / Ezetimibe FCDP Arm
|
ETC-1002-Glucuronide (FCDP)
n=8 Participants
Bempedoic Acid / Ezetimibe FCDP Arm
|
|---|---|---|---|---|---|---|
|
Time of Maximum Concentration (Tmax) of Bempedoic Acid and Metabolites in Breast Milk
|
2.94 Hours
Interval 2.8 to 6.0
|
NA Hours
Not applicable (NA) due to 7 out of 8 participants had ESP-15228 concentration below the lower limit of quantification (BLQ) (\<20.0) at all nominal timepoints.
|
8.92 Hours
Interval 5.7 to 12.0
|
2.93 Hours
Interval 2.8 to 8.9
|
NA Hours
Not applicable (NA) due to 7 out of 8 participants had ESP-15228 concentration below the lower limit of quantification (BLQ) (\<20.0) at all nominal timepoints.
|
8.93 Hours
Interval 5.8 to 19.7
|
SECONDARY outcome
Timeframe: 24 hours post Day 6 dose administrationPopulation: Pharmacokinetic Analysis Set.
Tmax of Ezetimibe and EZE-glucuronide in Breast Milk were analyzed for FCDP arm only.
Outcome measures
| Measure |
Bempedoic Acid
n=8 Participants
Bempedoic Acid Arm
|
Bempedoic Acid (FCDP)
n=8 Participants
Bempedoic Acid / Ezetimibe FCDP Arm
|
Ezetimibe (FCDP)
Bempedoic Acid / Ezetimibe FCDP Arm
|
ETC-1002 (FCDP)
Bempedoic Acid / Ezetimibe FCDP Arm
|
ESP-15228 (FCDP)
Bempedoic Acid / Ezetimibe FCDP Arm
|
ETC-1002-Glucuronide (FCDP)
Bempedoic Acid / Ezetimibe FCDP Arm
|
|---|---|---|---|---|---|---|
|
Tmax of Ezetimibe and Metabolite in Breast Milk
|
2.93 Hours
Interval 2.8 to 6.0
|
5.88 Hours
Interval 2.8 to 8.9
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 24 hours post Day 6 dose administrationPopulation: Pharmacokinetic Analysis Set. Only those participants with data available at specified time points has been presented.
AUC24h of ETC-1002, ESP-15228, and ETC-1002-glucuronide in Breast Milk were analyzed for Bempedoic Acid arm and FCDP arm respectively.
Outcome measures
| Measure |
Bempedoic Acid
n=8 Participants
Bempedoic Acid Arm
|
Bempedoic Acid (FCDP)
n=1 Participants
Bempedoic Acid / Ezetimibe FCDP Arm
|
Ezetimibe (FCDP)
n=8 Participants
Bempedoic Acid / Ezetimibe FCDP Arm
|
ETC-1002 (FCDP)
n=8 Participants
Bempedoic Acid / Ezetimibe FCDP Arm
|
ESP-15228 (FCDP)
n=1 Participants
Bempedoic Acid / Ezetimibe FCDP Arm
|
ETC-1002-Glucuronide (FCDP)
n=8 Participants
Bempedoic Acid / Ezetimibe FCDP Arm
|
|---|---|---|---|---|---|---|
|
Area Under the Breast Milk Concentration-time Curve Over the 24-hour Collection Interval (AUC24h) of Bempedoic Acid and Metabolites in Breast Milk
|
1765.86 Hours*nanograms per milliliter
Geometric Coefficient of Variation 40.88
|
NA Hours*nanograms per milliliter
Geometric Coefficient of Variation NA
Not applicable (NA) due to 7 out of 8 participants had ESP-15228 concentration below the lower limit of quantification (BLQ) (\<20.0) at all nominal timepoints.
|
1308.84 Hours*nanograms per milliliter
Geometric Coefficient of Variation 56.24
|
1618.25 Hours*nanograms per milliliter
Geometric Coefficient of Variation 39.67
|
NA Hours*nanograms per milliliter
Geometric Coefficient of Variation NA
Not applicable (NA) due to 7 out of 8 participants had ESP-15228 concentration below the lower limit of quantification (BLQ) (\<20.0) at all nominal timepoints.
|
1057.69 Hours*nanograms per milliliter
Geometric Coefficient of Variation 43.21
|
SECONDARY outcome
Timeframe: 24 hours post Day 6 dose administrationPopulation: Pharmacokinetic Analysis Set.
AUC24h of Ezetimibe and EZE-glucuronide in Breast Milk were analyzed for FCDP arm only.
Outcome measures
| Measure |
Bempedoic Acid
n=8 Participants
Bempedoic Acid Arm
|
Bempedoic Acid (FCDP)
n=8 Participants
Bempedoic Acid / Ezetimibe FCDP Arm
|
Ezetimibe (FCDP)
Bempedoic Acid / Ezetimibe FCDP Arm
|
ETC-1002 (FCDP)
Bempedoic Acid / Ezetimibe FCDP Arm
|
ESP-15228 (FCDP)
Bempedoic Acid / Ezetimibe FCDP Arm
|
ETC-1002-Glucuronide (FCDP)
Bempedoic Acid / Ezetimibe FCDP Arm
|
|---|---|---|---|---|---|---|
|
AUC24h of Ezetimibe and Metabolite in Breast Milk
|
7.79 Hours*nanograms per milliliter
Geometric Coefficient of Variation 38.29
|
41.09 Hours*nanograms per milliliter
Geometric Coefficient of Variation 66.10
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 24 hours post Day 6 dose administrationPopulation: Pharmacokinetic Analysis Set. Only those participants with data available at specified time points has been presented.
Cavg (defined as AUC24h/24h) of ETC-1002, ESP-15228, and ETC-1002-glucuronide in Breast Milk were analyzed for Bempedoic Acid arm and FCDP arm respectively.
Outcome measures
| Measure |
Bempedoic Acid
n=8 Participants
Bempedoic Acid Arm
|
Bempedoic Acid (FCDP)
n=1 Participants
Bempedoic Acid / Ezetimibe FCDP Arm
|
Ezetimibe (FCDP)
n=8 Participants
Bempedoic Acid / Ezetimibe FCDP Arm
|
ETC-1002 (FCDP)
n=8 Participants
Bempedoic Acid / Ezetimibe FCDP Arm
|
ESP-15228 (FCDP)
n=1 Participants
Bempedoic Acid / Ezetimibe FCDP Arm
|
ETC-1002-Glucuronide (FCDP)
n=8 Participants
Bempedoic Acid / Ezetimibe FCDP Arm
|
|---|---|---|---|---|---|---|
|
Average Concentration (Cavg) of Bempedoic Acid and Metabolites in Breast Milk
|
74.181 Nanograms per milliliter
Geometric Coefficient of Variation 40.75
|
NA Nanograms per milliliter
Geometric Coefficient of Variation NA
Not applicable (NA) due to 7 out of 8 participants had ESP-15228 concentration below the lower limit of quantification (BLQ) (\<20.0) at all nominal timepoints.
|
54.982 Nanograms per milliliter
Geometric Coefficient of Variation 55.98
|
67.848 Nanograms per milliliter
Geometric Coefficient of Variation 39.77
|
NA Nanograms per milliliter
Geometric Coefficient of Variation NA
Not applicable (NA) due to 7 out of 8 participants had ESP-15228 concentration below the lower limit of quantification (BLQ) (\<20.0) at all nominal timepoints.
|
44.346 Nanograms per milliliter
Geometric Coefficient of Variation 43.42
|
SECONDARY outcome
Timeframe: 24 hours post Day 6 dose administrationPopulation: Pharmacokinetic Analysis Set.
Cavg of Ezetimibe and EZE-glucuronide in Breast Milk were analyzed for FCDP arm only.
Outcome measures
| Measure |
Bempedoic Acid
n=8 Participants
Bempedoic Acid Arm
|
Bempedoic Acid (FCDP)
n=8 Participants
Bempedoic Acid / Ezetimibe FCDP Arm
|
Ezetimibe (FCDP)
Bempedoic Acid / Ezetimibe FCDP Arm
|
ETC-1002 (FCDP)
Bempedoic Acid / Ezetimibe FCDP Arm
|
ESP-15228 (FCDP)
Bempedoic Acid / Ezetimibe FCDP Arm
|
ETC-1002-Glucuronide (FCDP)
Bempedoic Acid / Ezetimibe FCDP Arm
|
|---|---|---|---|---|---|---|
|
Cavg of Ezetimibe and Metabolite in Breast Milk
|
0.327 Nanograms per milliliter
Geometric Coefficient of Variation 38.41
|
1.723 Nanograms per milliliter
Geometric Coefficient of Variation 66.03
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 24 hours post Day 6 dose administrationPopulation: Pharmacokinetic Analysis Set. Only those participants with data available at specified time points has been presented.
Ctrough\_milk of ETC-1002, ESP-15228, and ETC-1002-glucuronide were analyzed for Bempedoic Acid arm and FCDP arm respectively.
Outcome measures
| Measure |
Bempedoic Acid
n=8 Participants
Bempedoic Acid Arm
|
Bempedoic Acid (FCDP)
n=1 Participants
Bempedoic Acid / Ezetimibe FCDP Arm
|
Ezetimibe (FCDP)
n=8 Participants
Bempedoic Acid / Ezetimibe FCDP Arm
|
ETC-1002 (FCDP)
n=8 Participants
Bempedoic Acid / Ezetimibe FCDP Arm
|
ESP-15228 (FCDP)
n=1 Participants
Bempedoic Acid / Ezetimibe FCDP Arm
|
ETC-1002-Glucuronide (FCDP)
n=8 Participants
Bempedoic Acid / Ezetimibe FCDP Arm
|
|---|---|---|---|---|---|---|
|
Trough Concentration (Ctrough) of Bempedoic Acid and Metabolites in Breast Milk
|
50.58 Nanograms per milliliter
Geometric Coefficient of Variation 47.59
|
NA Nanograms per milliliter
Geometric Coefficient of Variation NA
Not applicable (NA) due to 7 out of 8 participants had ESP-15228 concentration below the lower limit of quantification (BLQ) (\<20.0) at all nominal timepoints.
|
45.55 Nanograms per milliliter
Geometric Coefficient of Variation 62.72
|
58.60 Nanograms per milliliter
Geometric Coefficient of Variation 53.36
|
NA Nanograms per milliliter
Geometric Coefficient of Variation NA
Not applicable (NA) due to 7 out of 8 participants had ESP-15228 concentration below the lower limit of quantification (BLQ) (\<20.0) at all nominal timepoints.
|
39.32 Nanograms per milliliter
Geometric Coefficient of Variation 51.81
|
SECONDARY outcome
Timeframe: 24 hours post Day 6 dose administrationPopulation: Pharmacokinetic Analysis Set.
Ctrough\_milk of Ezetimibe and EZE-glucuronide were analyzed for FCDP arm only.
Outcome measures
| Measure |
Bempedoic Acid
n=8 Participants
Bempedoic Acid Arm
|
Bempedoic Acid (FCDP)
n=8 Participants
Bempedoic Acid / Ezetimibe FCDP Arm
|
Ezetimibe (FCDP)
Bempedoic Acid / Ezetimibe FCDP Arm
|
ETC-1002 (FCDP)
Bempedoic Acid / Ezetimibe FCDP Arm
|
ESP-15228 (FCDP)
Bempedoic Acid / Ezetimibe FCDP Arm
|
ETC-1002-Glucuronide (FCDP)
Bempedoic Acid / Ezetimibe FCDP Arm
|
|---|---|---|---|---|---|---|
|
Ctrough of Ezetimibe and Metabolite in Breast Milk
|
0.25 Nanograms per milliliter
Geometric Coefficient of Variation 38.66
|
1.33 Nanograms per milliliter
Geometric Coefficient of Variation 82.37
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 24 hours post Day 6 dose administrationPopulation: Pharmacokinetic Analysis Set.
Ctrough\_plasma of ETC-1002, ESP-15228, and ETC-1002-glucuronide were analyzed for Bempedoic Acid arm and FCDP arm respectively.
Outcome measures
| Measure |
Bempedoic Acid
n=8 Participants
Bempedoic Acid Arm
|
Bempedoic Acid (FCDP)
n=8 Participants
Bempedoic Acid / Ezetimibe FCDP Arm
|
Ezetimibe (FCDP)
n=8 Participants
Bempedoic Acid / Ezetimibe FCDP Arm
|
ETC-1002 (FCDP)
n=8 Participants
Bempedoic Acid / Ezetimibe FCDP Arm
|
ESP-15228 (FCDP)
n=8 Participants
Bempedoic Acid / Ezetimibe FCDP Arm
|
ETC-1002-Glucuronide (FCDP)
n=8 Participants
Bempedoic Acid / Ezetimibe FCDP Arm
|
|---|---|---|---|---|---|---|
|
Ctrough of Bempedoic Acid and Metabolites in Plasma
|
10025.6 Nanograms per milliliter
Geometric Coefficient of Variation 25.46
|
1862.4 Nanograms per milliliter
Geometric Coefficient of Variation 34.04
|
4904.9 Nanograms per milliliter
Geometric Coefficient of Variation 35.65
|
9665.9 Nanograms per milliliter
Geometric Coefficient of Variation 37.95
|
1641.8 Nanograms per milliliter
Geometric Coefficient of Variation 20.78
|
4984.7 Nanograms per milliliter
Geometric Coefficient of Variation 35.65
|
SECONDARY outcome
Timeframe: 24 hours post Day 6 dose administrationPopulation: Pharmacokinetic Analysis Set.
Ctrough\_plasma of Ezetimibe and EZE-glucuronide were analyzed for FCDP arm only.
Outcome measures
| Measure |
Bempedoic Acid
n=8 Participants
Bempedoic Acid Arm
|
Bempedoic Acid (FCDP)
n=8 Participants
Bempedoic Acid / Ezetimibe FCDP Arm
|
Ezetimibe (FCDP)
Bempedoic Acid / Ezetimibe FCDP Arm
|
ETC-1002 (FCDP)
Bempedoic Acid / Ezetimibe FCDP Arm
|
ESP-15228 (FCDP)
Bempedoic Acid / Ezetimibe FCDP Arm
|
ETC-1002-Glucuronide (FCDP)
Bempedoic Acid / Ezetimibe FCDP Arm
|
|---|---|---|---|---|---|---|
|
Ctrough of Ezetimibe and Metabolite in Plasma
|
2.29 Nanograms per milliliter
Geometric Coefficient of Variation 69.37
|
35.76 Nanograms per milliliter
Geometric Coefficient of Variation 77.54
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 24 hours post Day 6 dose administrationPopulation: Pharmacokinetic Analysis Set. Only those participants with data available at specified time points has been presented.
M/P Ratio of ETC-1002, ESP-15228, and ETC-1002-glucuronide were analyzed for Bempedoic Acid arm and FCDP arm respectively.
Outcome measures
| Measure |
Bempedoic Acid
n=8 Participants
Bempedoic Acid Arm
|
Bempedoic Acid (FCDP)
n=1 Participants
Bempedoic Acid / Ezetimibe FCDP Arm
|
Ezetimibe (FCDP)
n=8 Participants
Bempedoic Acid / Ezetimibe FCDP Arm
|
ETC-1002 (FCDP)
n=8 Participants
Bempedoic Acid / Ezetimibe FCDP Arm
|
ESP-15228 (FCDP)
n=1 Participants
Bempedoic Acid / Ezetimibe FCDP Arm
|
ETC-1002-Glucuronide (FCDP)
n=8 Participants
Bempedoic Acid / Ezetimibe FCDP Arm
|
|---|---|---|---|---|---|---|
|
Ctrough_milk/Ctrough_plasma (M/P Ratio) of Bempedoic Acid and Metabolites
|
0.005 Ratio
Geometric Coefficient of Variation 25.35
|
NA Ratio
Geometric Coefficient of Variation NA
Not applicable (NA) due to 7 out of 8 participants had ESP-15228 concentration below the lower limit of quantification (BLQ) (\<20.0) at all nominal timepoints.
|
0.009 Ratio
Geometric Coefficient of Variation 29.05
|
0.006 Ratio
Geometric Coefficient of Variation 59.39
|
NA Ratio
Geometric Coefficient of Variation NA
Not applicable (NA) due to 7 out of 8 participants had ESP-15228 concentration below the lower limit of quantification (BLQ) (\<20.0) at all nominal timepoints.
|
0.008 Ratio
Geometric Coefficient of Variation 63.91
|
SECONDARY outcome
Timeframe: 24 hours post Day 6 dose administrationPopulation: Pharmacokinetic Analysis Set.
M/P Ratio of Ezetimibe and EZE-glucuronide were analyzed for FCDP arm only.
Outcome measures
| Measure |
Bempedoic Acid
n=8 Participants
Bempedoic Acid Arm
|
Bempedoic Acid (FCDP)
n=8 Participants
Bempedoic Acid / Ezetimibe FCDP Arm
|
Ezetimibe (FCDP)
Bempedoic Acid / Ezetimibe FCDP Arm
|
ETC-1002 (FCDP)
Bempedoic Acid / Ezetimibe FCDP Arm
|
ESP-15228 (FCDP)
Bempedoic Acid / Ezetimibe FCDP Arm
|
ETC-1002-Glucuronide (FCDP)
Bempedoic Acid / Ezetimibe FCDP Arm
|
|---|---|---|---|---|---|---|
|
M/P Ratio of Ezetimibe and Metabolite
|
0.108 Ratio
Geometric Coefficient of Variation 62.21
|
0.037 Ratio
Geometric Coefficient of Variation 81.68
|
—
|
—
|
—
|
—
|
Adverse Events
Bempedoic Acid
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Bempedoic Acid / Ezetimibe FCDP
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Bempedoic Acid
n=8 participants at risk
Participants received bempedoic acid 180 mg oral tablet for 6 days
|
Bempedoic Acid / Ezetimibe FCDP
n=8 participants at risk
Participants received bempedoic acid 180 mg/ezetimibe 10 mg FCDP oral tablets for 6 days
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal discomfort
|
12.5%
1/8 • Up to Day 43
Treatment emergent adverse events and serious adverse events were collected in Full Analysis Set.
|
12.5%
1/8 • Up to Day 43
Treatment emergent adverse events and serious adverse events were collected in Full Analysis Set.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/8 • Up to Day 43
Treatment emergent adverse events and serious adverse events were collected in Full Analysis Set.
|
25.0%
2/8 • Up to Day 43
Treatment emergent adverse events and serious adverse events were collected in Full Analysis Set.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/8 • Up to Day 43
Treatment emergent adverse events and serious adverse events were collected in Full Analysis Set.
|
25.0%
2/8 • Up to Day 43
Treatment emergent adverse events and serious adverse events were collected in Full Analysis Set.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/8 • Up to Day 43
Treatment emergent adverse events and serious adverse events were collected in Full Analysis Set.
|
12.5%
1/8 • Up to Day 43
Treatment emergent adverse events and serious adverse events were collected in Full Analysis Set.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/8 • Up to Day 43
Treatment emergent adverse events and serious adverse events were collected in Full Analysis Set.
|
12.5%
1/8 • Up to Day 43
Treatment emergent adverse events and serious adverse events were collected in Full Analysis Set.
|
|
General disorders
Asthenia
|
0.00%
0/8 • Up to Day 43
Treatment emergent adverse events and serious adverse events were collected in Full Analysis Set.
|
25.0%
2/8 • Up to Day 43
Treatment emergent adverse events and serious adverse events were collected in Full Analysis Set.
|
|
Infections and infestations
Rhinitis
|
12.5%
1/8 • Up to Day 43
Treatment emergent adverse events and serious adverse events were collected in Full Analysis Set.
|
0.00%
0/8 • Up to Day 43
Treatment emergent adverse events and serious adverse events were collected in Full Analysis Set.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/8 • Up to Day 43
Treatment emergent adverse events and serious adverse events were collected in Full Analysis Set.
|
12.5%
1/8 • Up to Day 43
Treatment emergent adverse events and serious adverse events were collected in Full Analysis Set.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/8 • Up to Day 43
Treatment emergent adverse events and serious adverse events were collected in Full Analysis Set.
|
12.5%
1/8 • Up to Day 43
Treatment emergent adverse events and serious adverse events were collected in Full Analysis Set.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/8 • Up to Day 43
Treatment emergent adverse events and serious adverse events were collected in Full Analysis Set.
|
12.5%
1/8 • Up to Day 43
Treatment emergent adverse events and serious adverse events were collected in Full Analysis Set.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
12.5%
1/8 • Up to Day 43
Treatment emergent adverse events and serious adverse events were collected in Full Analysis Set.
|
0.00%
0/8 • Up to Day 43
Treatment emergent adverse events and serious adverse events were collected in Full Analysis Set.
|
|
Nervous system disorders
Headache
|
25.0%
2/8 • Up to Day 43
Treatment emergent adverse events and serious adverse events were collected in Full Analysis Set.
|
0.00%
0/8 • Up to Day 43
Treatment emergent adverse events and serious adverse events were collected in Full Analysis Set.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/8 • Up to Day 43
Treatment emergent adverse events and serious adverse events were collected in Full Analysis Set.
|
12.5%
1/8 • Up to Day 43
Treatment emergent adverse events and serious adverse events were collected in Full Analysis Set.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee If the Principal Investigator plans to publish information from the study, a copy of the manuscript should be provided to the Sponsor for review before submission for publication or presentation. The Sponsor may request that that publication be withheld.
- Publication restrictions are in place
Restriction type: OTHER