Clinical pharmacology study of K-237

Phase 1

• Conditions: COVID-19

• Registration Number: JPRN-jRCT2071210085
• Lead Sponsor: Tanigawa Ryohei

Brief Summary

Plasma IVM B1a (unchanged Ivermectin) concentration after K-237 administration can be affected by food. No clinically relevant adverse events or side effects were observed.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-10-26
• Study Completion: 2021-11-26
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 23

Inclusion 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.

Exclusion 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).

Study & Design

• Study Type: Interventional
• Study Design: Not specified