None listed
Conditions
Interventions
Drug : The starting dose of baloxavir marboxil will be 20 mg, administered once orally to subjects in the first group. The dose will be increased by up to 100 %
of the preceding dose level for each successive dose level, until a dose of 80 mg is reached or a safety threshold (defined as a DLT in at least 3 subjects during the dose-escalation assessment window
Sponsors
Roche Korea
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: · Subjects who are able to understand the study and comply with all study procedures and willing to provide written informed consent prior to screening. · Korean male subjects aged from 19 to 45 years at time of signing Informed Consent Form · Healthy adults: determined by the investigator or sub-investigator, based on a medical evaluation including medical history, physical examination, laboratory tests and electrocardiogram. In the case of subjects with clinically significant findings or with clinical laboratory test results beyond upper limit of normal (ULN), subjects must be considered appropriate for the study by the investigator or sub-investigator with consideration of additional risk for participation in the study. · Body weight between 50 to 80 kg (typical body weight) and body mass index (BMI) between 18.5 to 25 kg/m2 inclusive. At dose level D only, body weight above 80 kg (typical body weight) inclusive. · Ability to comply with the study protocol, in the investigator’s judgment
Exclusion criteria
Exclusion criteria: · Subjects who are considered ineligible for this study by the investigator or subinvestigator due to current or history of significant metabolic, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, urological, endocrine, neurological, or psychiatric disorders with clinical manifestations. · Subjects with the following laboratory abnormalities pre-dose: - total bilirubin > 1.5 x ULN - aspartate aminotransferase (AST) > 1.5 x ULN - alanine aminotransferase (ALT) > 1.5 x ULN - estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m2 · QTc interval > 450 msec (with Fridericia’s correction) · Subjects whose systolic blood pressure is outside the range of 80-150 mmHg, or diastolic blood pressure is outside the range of 40-100 mmHg, or pulse rate is outside the range of 40-100 bpm. · Subjects with a history of stomach, vagus nerve, or intestinal surgery (except for appendectomy). · Subjects who have a history of allergic symptoms including food allergy (NOTE: Nonactive allergic rhinitis will be allowed). · Subjects who require chronic drug therapy or those who have used drugs (eg,prescription or over-the-counter drugs, herbal and dietary supplements, vitamins) within 3 days prior to screening or within 14 days prior to administration of the study drug. · Subjects who have used alcohol-containing, caffeine-containing, grapefruit containing,or St. John’s wort-containing products within 72 hours prior to administration of the study drug. · Subjects who have used tobacco- or nicotine-containing products between 24 weeks prior to screening and administration of the study drug. · Subjects who have a history of abuse of drugs and/or alcohol. · Subjects who have a positive pre-study urine drug/alcohol screen. · Subjects who are positive for serological test for syphilis (Rapid Plasma Reagin [RPR]), hepatitis B surface (HBs) antigen, hepatitis C virus (HCV) antibody, or HIV antibody at screening. · Subjects who have donated > 400 mL of blood within 12 weeks or > 200 mL of blood within 4 weeks prior to screening, or have donated any amount of blood between screening and administration of the study drug. · Subjects who have been exposed to an investigational drug within 90 days prior to the administration of the study drug. · Subjects who have received baloxavir marboxil previously. · Subjects who are considered inappropriate for the study by the investigator or subinvestigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum plasma concentration (Cmax),Time to maximum plasma concentration (Tmax),Area under the plasma concentration-time curve (AUC0-last,AUC0-72), Terminal elimination half-life (t1/2), Mean residence time (MRT), Apparent total clearance (CL/F), Apparent volume of distribution based on the terminal phase (Vz/F), Plasma concentration at 24 hours (C24), 48 hours (C48) and 72 hours (C72) post-dose | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety - Incidence, severity, and timing of adverse events, serious adverse events, vital sign measurements, 12-Lead ECGs, physical examinations, and clinical laboratory test results | — |
Countries
Korea, Republic of
Contacts
Public ContactInjin Jang
Seoul National University Hospital
Outcome results
None listed