Clinical pharmacology study of K-237

JRCT ID: jRCT2071210085

Registered date:26/10/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: COVID-19
• Date of first enrollment: 26/10/2021
• Target sample size: 12
• Study type: Interventional

Intervention(s)

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

Outcome(s)

• Primary Outcome: Adverse events and adverse drug reactions

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 40age old
• Gender: Both

Include criteria

(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.

Exclude criteria

(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).

Related Information

• Primary Sponsor: Tanigawa Ryohei