NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCT2031240587

Registered date:27/12/2024

A Phase 1 BA/FE Study of Ensitrelvir Granules (COVID-19)

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedCOVID-19
Date of first enrollment16/12/2024
Target sample size28
Countries of recruitment
Study typeInterventional
Intervention(s)Oral administration of ensitrelvir

Outcome(s)

Primary OutcomePharmacokinetics parameters
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum>= 18age old
Age maximum<= 55age old
GenderBoth
Include criteriaApparently healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and 12-lead ECG. A person with Japanese parents Participant must be 18 to 55 years of age inclusive, at the time of signing the ICF. BMI >= 18.5 and 30.0 <= Male and female
Exclude criteriaPresence or History of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders that may significantly alter the absorption, metabolism, or elimination of drugs; determined to constitute a risk when administering the study intervention or to interfere with the interpretation of data. Participants whose systolic blood pressure is outside the range of 90 to 140 mmHg, diastolic blood pressure is outside the range of 50 to 90 mmHg, or pulse rate is outside the range of 50 to 100 bpm at rest at screening or on admission (day -1) and who are considered ineligible for the study by the investigator. Any of the following abnormalities at screening or on admission (day -1): - Total bilirubin: > 1.5 x upper limit of normal (ULN) based on the facility criteria - Alanine aminotransferase (ALT): > 1.5 x ULN based on the facility criteria - Aspartate aminotransferase (AST): > 1.5 x ULN based on the facility criteria - Creatinine clearance (CLcr) (Cockcroft-Gault formula): < 90 mL/min

Related Information

Contact

Public contact
Name - - Corporate Communications Department
Address 1-8, Doshomachi 3-chome, Chuo-ku, Osaka, Osaka Osaka Japan 541-0045
Telephone +81-6-6209-7885
E-mail shionogiclintrials-admin@shionogi.co.jp
Affiliation Shionogi &amp; Co., Ltd.
Scientific contact
Name Juan Carlos - Gomez
Address 1-8, Doshomachi 3-chome, Chuo-ku, Osaka, Osaka Osaka Japan 541-0045
Telephone +81-6-6209-7885
E-mail shionogiclintrials-admin@shionogi.co.jp
Affiliation Shionogi &amp; Co., Ltd.