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

JRCT ID: jRCT2051210203

Registered date:23/03/2022

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: COVID-19
• Date of first enrollment: 19/05/2022
• Target sample size: 20
• Study type: Interventional

Intervention(s)

- Clarithromycin administration group:
K-237 3 mg single dose administration under fasting
Clarithromycin 400 mg twice daily before breakfast and supper
- Rifampicin administration group:
K-237 0.3-0.4 mg / kg single dose administration under fasting
Rifampicin 600 mg once daily before breakfast

Outcome(s)

• Primary Outcome: Plasma pharmacokinetic parameters

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 45age old
• Gender: Male

Include 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.

Exclude 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).

Related Information

• Primary Sponsor: Tanigawa Ryohei