COVID-19
Conditions
Interventions
Oral administration of ensitrelvir
Sponsors
Gomez - Juan Carlos
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Apparently 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
Exclusion criteria
Exclusion criteria: Presence 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics parameters | — |
Contacts
Public Contact- Corporate Communications Department
Shionogi & Co., Ltd.
Outcome results
None listed