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

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)

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2051220054
Enrollment
10
Registered
2022-06-18
Start date
2022-07-11
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19

Interventions

- 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

Sponsors

Tanigawa Ryohei
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: (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.

Exclusion criteria

Exclusion criteria: (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).

Design outcomes

Primary

MeasureTime frame
Plasma pharmacokinetic parameters

Contacts

Public Contact- Contact for clinical trial information

Kowa Company, Ltd.

ctrdinfo@kowa.co.jp+81-3-3279-7454

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026