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Clinical pharmacology study of K-237 in healthy adult volunteers

Clinical pharmacology study of K-237

23

K-237 fasting administration group (n=6) [Sex] Male: 6 subjects (100.0%), Female 0 subjects (0.0%) [Age, Mean (SD)] 23.0 (2.9) years [Weight, Mean (SD)] 66.95(8.14)kg [Height, Mean(SD)] 170.38(4.85)cm [Body Mass Index, Mean(SD)] 23.03(2.66)kg/m2 [weight,category]<59.5 kg: 2 subjects (33.3%), 59.5 kg <=: 4 subjects (66.7%) K-237 after breakfast administration group (n=6) [Sex] Male: 6 subjects (100.0%), Female: 0 subjects (0.0%) [Age, Mean (SD)] 29.3(8.7) years [Weight, Mean (SD)] 63.33(5.27)kg [Height, Mean(SD)] 169.77(7.31)cm [Body Mass Index, Mean(SD)] 22.23(2.37)kg/m2 [weight,category]<59.5 kg: 2 subjects (33.3%), 59.5 kg <=: 4 subjects (66.7%)

Informed Consent Obtained: 23 subjects Randomized: 12 subjects (K-237 fasting administration group: 6, K-237 after breakfast administration group: 6) Completed: 12 subjects (K-237 fasting administration group: 6, K-237 after breakfast administration group: 6) Primary Efficacy Analysis Set: 12 Randomized subjects Safety Analysis Set: 12 Randomized subjects

An adverse event, "blood potassium increased," was observed in one subject in the fasting administration group, but it was mild and non-serious, a causal relationship with the study drug was ruled out. No deaths or other serious adverse events were observed.

<PK parameters> For the PK parameters of IVM B1a (unchanged Ivermectin) following K-237 at 0.3-0.4 mg/kg once daily for 3 days, the geometric mean of Cmax was 134.943 ng/mL and 197.172 ng/mL in fasting and post-breakfast groups, respectively, with AUC0-T of 1793.262 ng*h/mL and 2846.272 ng*h/mL, respectively. The geometric mean of MRTss was 43.83 h and 56.13 h in the fasting and post-breakfast groups, respectively, with a median tmax of 3.500 h and 5.000 h and a geometric mean of t1/2 of 45.516 h and 53.799 h, respectively. <Safety> An adverse event ""increase in blood potassium"" was observed in one patient in the fasting group. It was mild and not serious, a causal relationship with the study drug was ruled out, and the event resolved without treatment.

Plasma IVM B1a (unchanged Ivermectin) concentration after K-237 administration can be affected by food. No clinically relevant adverse events or side effects were observed.

No

https://jrct.mhlw.go.jp/latest-detail/jRCT2071210085

Tanigawa Ryohei

Kowa Company, Ltd.

4-14, Nihonbashi-honcho 3-chome, Chuo-ku, Tokyo

ctrdinfo@kowa.co.jp

- Contact for clinical trial information

Kowa Company, Ltd.

4-14, Nihonbashi-honcho 3-chome, Chuo-ku, Tokyo

+81-3-3279-7454

ctrdinfo@kowa.co.jp

Complete

Oct. 21, 2021

Interventional

randomized controlled trial

open(masking not used)

uncontrolled control

parallel assignment

treatment purpose

(1) Subject is a healthy adult volunteer.
(2) Subject is between the ages of 20 and 40 years at the time of signing informed consent.
(3) Subject has a body mass index of 17.6 to 26.4 kg/m2 at Screening.

(1) Subject has a supine blood pressure after resting for at least 5 minutes that is lower than 90 mmHg systolic or higher than 140 mmHg systolic, and lower than 40 mmHg diastolic or higher than 90 mmHg diastolic at Screening.
(2) Subject has used a drug (including over-the-counter drug) within 14 days before the administration of the study drug or a supplement within 4 weeks before the administration of the study drug, or those who need to use it during the study period.
(3) Subject has a current malabsorption, and those who had an operation on the gastrointestinal tract that may affect absorption (excluding appendectomy and treatment for hernia).

Both

COVID-19

K-237 under fasting administration group: K-237 0.3-0.4 mg / kg once daily for 3 days under fasting
K-237 after breakfast administration group: K-237 0.3-0.4 mg / kg once daily for 3 days after breakfast

Adverse events and adverse drug reactions

+81-942-35-3705

Oct. 20, 2021

none