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MND-2119 Clinical Pharmacology Study

MND-2119 Clinical Pharmacology Study

32

Age (mean (SD)) in the control, MND-2119 2-g, MND-2119 4-g, and EPA-E 1.8-g groups was 29.0 (7.2) years, 25.0 (5.9) years, 26.0 (4.1) years, and 30.5 (5.6) years, respectively. BMI (mean (SD)) in these groups in the same order was 21.66 (1.62) kg/m2, 21.30 (2.16) kg/m2, 21.48 (1.66) kg/m2, and 21.69 (1.63) kg/m2, respectively.

There were 32 subjects (N = 8 for each group), and no subjects discontinued the study.

The incidence of adverse events (AEs) reported in the study in the control, MND-2119 2-g, MND-2119 4-g, and EPA-E 1.8-g groups was 12.5% (1/8 subjects), 62.5% (5/8 subjects), 37.5% (3/8 subjects), and 25.0% (2/8 subjects), respectively. The incidence of adverse drug reactions in these groups in the same order was 0% (0/8 subjects), 62.5% (5/8 subjects), 37.5% (3/8 subjects), and 25.0% (2/8 subjects), respectively. The only AE reported in two or more subjects in any group was diarrhea (one in the control group, two each in the MND-2119 2- and 4-g groups, and one in the EPA-E 1.8-g group). All the AEs reported in the study were mild and nonserious, did not result in discontinuation of study treatment, and were resolved.

<Plasma total EPA and EPA/AA ratio> At 3 h (hour) postdose on Days 1 and 7, changes in plasma total EPA concentrations were significantly higher in the MND-2119 2-g group than in the EPA-E 1.8-g group. At all the time points, changes in plasma total EPA concentrations were significantly higher in the MND-2119 4-g group than in the MND-2119 2-g group. Changes in the plasma EPA/AA ratio showed a similar trend to plasma total EPA concentrations. <EPA-derived metabolites in plasma> Plasma 18-HEPE concentrations were significantly higher in the MND-2119 2-g group than in the EPA-E 1.8-g group at 3 h on Days 1 and 7 and were significantly higher in the MND-2119 4-g group than in the MND-2119 2-g group at 3 h on Day 1 and 24 h on Day 7. Plasma 17,18-EpETE concentration showed a similar trend to plasma 18-HEPE concentration. RvE1 levels under static condition were below the lower limit of quantification (BLQ) in most plasma samples. <Total EPA in blood cells> In blood cells, there were only slight changes in total EPA concentration on Day 1, but it increased significantly after 7-day multiple administrations in the MND-2119 2-g, MND-2119 4-g, and EPA-E 1.8-g groups. <EPA-derived metabolite production by neutrophils> RvE1 and 17,18-EpETE levels were BLQ in most samples. The amounts of 18-HEPE produced in some samples were also BLQ, making group comparisons difficult. However, in a correlation analysis of 18-HEPE production and the total EPA concentration in neutrophils on Day 7 (3 and 24 h), indicating a positive correlation between them. <Cytokine> The cytokine production from LPS-stimulated ex vivo whole blood culture changed little over time among treatment groups.

These results demonstrate that MND-2119 increases the plasma and cellular concentrations of EPA and EPA-derived metabolites to a greater extent than conventional EPA-E formulations.

Aug. 02, 2023

https://pubmed.ncbi.nlm.nih.gov/37532570/

No

https://jrct.niph.go.jp/latest-detail/jRCT2031210362

Mori Takuya

Mochida Pharmaceutical Co., Ltd.

7, Yotsuya 1-chome, Shinjuku-ku, Tokyo

clinical.trials.contact@mochida.co.jp

relations Public

Mochida Pharmaceutical Co., Ltd.

7, Yotsuya 1-chome, Shinjuku-ku, Tokyo

+81-3-3225-6303

webmaster@mochida.co.jp

Complete

Sept. 23, 2021

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

treatment purpose

Male participants willing to participate in this clinical trial with the ability to consent and provide written consent

Participants with or with a history of, cardiac, hepatic, renal, respiratory, hematologic, gastrointestinal, thyroid gland, psychological, neurologic, metabolic, and electrolyte disorders that are considered by the principal (or sub-) investigator as ineligible to participate in the study

Male

Healthy adult subjects

No intervention arm
MND-2119 2 g arm:MND-2119 2 g, orally, once daily after breakfast.
MND-2119 4 g arm:MND-2119 4 g, orally, once daily after breakfast.
EPADEL 1.8 g arm:Ethyl icosapentate 0.9 g, orally, twice daily after breakfast and dinner.

Fatty acid composition of plasma and blood cells
Leukocyte-derived EPA metabolites
Cytokine

+81-3-5791-6177

Sept. 22, 2021

none