Drug-drug interaction study of K-237 (clarithromycin, rifampicin)

Phase 1

• Conditions: COVID-19

• Registration Number: JPRN-jRCT2051210203
• Lead Sponsor: Tanigawa Ryohei

Brief Summary

Cmax and AUC0-72h of K-237 increased when K-237 was co-administered with clarithromycin, while these parameters decreased when K-237 was administered following repeated dosing of rifampicin, suggesting that K-237 may be affected by drug interactions with clarithromycin or rifampicin. Finally, no safety issues were identified in the treatment periods.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-03-23
• Study Completion: 2022-08-19
• Last Update Posted: 1 April 2024

Recruitment & Eligibility

• Status: Complete
• Sex: Male
• Target Recruitment: 30

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

(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).

Study & Design

• Study Type: Interventional
• Study Design: Not specified