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Drug-drug interaction study to assess the effects of administration of K-237 on the pharmacokinetics of digoxin or rosuvastatin in healthy adult volunteers (COVID-19)

Drug-drug interaction study of K-237 (digoxin, rosuvastatin)

18

[Age, Mean(SD)] 26.5 (5.1) [Weight, Mean(SD)] 70.44(7.60)kg [Height, Mean(SD)] 176.67(5.82)cm [Bode Mass Index, Mean(SD)] 22.52(1.53)kg/m2

Informed Consent Obtained: 18 subjects Treatment Period 1 Completion: 10 subjects Treatment Period 2 Completion : 10 subjects Primary Efficacy Analysis Set: 10 subjects Safety Analysis Set: 10 subjects

Among the 10 subjects who received a study drug, an adverse event and an adverse drug reaction were observed in one subject each after having received K-237 in Treatment Period 2 (Pre-dose period). The adverse event and adverse drug reaction were "Faeces soft". The event and reaction were considered causally related to the study drug, but the event and reaction were mild and resolved without treatment. No death, other serious adverse events, or other significant adverse events were reported.

The geometric mean ratios (90% CI) of Cmax and AUC0-t in Treatment Period 2 to those in Treatment Period 1 were 1.486 (1.178 to 1.875) and 1.221 (0.934 to 1.597) for unchanged digoxin, respectively, and 1.192 (1.029 to 1.382) and 1.095 (1.014 to 1.184) for unchanged rosuvastatin, respectively.

In K-237-05, the drug interaction of K-237 affecting PK of digoxin and rosuvastatin was confirmed by comparing the plasma PK parameters for unchanged digoxin and unchanged rosuvastatin of a single oral dose of digoxin and rosuvastatin, and a 3-day repeated dose of K-237 followed by a single oral dose of digoxin and rosuvastatin, in healthy adult male subjects. In addition, the safety of the treatment periods was also examined.

No

https://jrct.mhlw.go.jp/latest-detail/jRCT2051220054

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

July. 01, 2022

Interventional

non-randomized controlled trial

open(masking not used)

uncontrolled control

crossover assignment

treatment purpose

(1) Subject is a healthy adult male volunteer.
(2) Subject is between the ages of 18 and 45 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 used a drug (including over-the-counter drug, vaccination) within 14 days before the administration of the study drug in the first treatment period, or those who need to use it during the study period.
(2) Subject has received products containing St John's wort within 4 weeks before the administration of the study drug in the first treatment period. Subject has received supplements and products containing grapefruit within 14 days before the administration of the study drug in the first treatment period.
(3) Subject has a current malabsorption, and those who had an operation on the gastrointestinal tract that may affect absorption (excluding appendectomy).

Male

COVID-19

- K-237 0.3-0.4 mg / kg once daily for 3 days under fasting
- Digoxin 0.25 mg single dose administration under fasting
- Rosuvastatin 5 mg single dose administration under fasting

Plasma pharmacokinetic parameters

+81-6-6395-9000

July. 01, 2022

none