COVID-19 trials registries data warehouse

https://jrct.niph.go.jp/latest-detail/jRCT2071210085

Contact for clinical trial information -

ctrdinfo@kowa.co.jp

2021-10-26

Not recruiting

RCT

Randomized

Parallel

Open label

unclear

Prevention

(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.

(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).

2

Tanigawa Ryohei

20

40

Japan

Healthy volunteers

N/A

12

Adverse events and adverse drug reactions

Phase 1

[{"arm_notes": "under fasting administration group: K-237 0.3-0.4 mg / kg once daily for 3 days under fasting", "treatment_id": 2007, "treatment_name": "K237", "treatment_type": "Others pharmacological treatment", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "after breakfast administration group: K-237 0.3-0.4 mg / kg once daily for 3 days after breakfast", "treatment_id": 2007, "treatment_name": "K237", "treatment_type": "Others pharmacological treatment", "pharmacological_treatment": "Pharmacological treatment"}]