No indication
Conditions
Interventions
investigational material(s)
Generic name etc : Napabucasin
INN of investigational material : Napabucasin
Therapeutic category code : 4-- Agents affecting cellular function
Dosage and Administration fo
Sponsors
Sumitomo Dainippon Pharma. Co,.Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects who met all of the following inclusion criteria were selected. 1) Subjects who provided written voluntary informed consent after fully receiving and understanding the information including the study objectives, contents, expected drug effect and pharmacological action and risks, before participation in this study 2) Subjects who were capable of and willing to fulfil the study requirements during participation in the study, undergo protocol-stipulated physical examination and other examinations, and report symptoms or other abnormalities 3) Subjects aged between 20 and =50.0 kg and =18.5 and =40.0 kg and =16.8 and =50.0 kg and =18.5 and < 30.0 at screening examination. BMI was calculated as follows: BMI = body weight (kg) / [height (m)]2 9) Subjects whose education level was high enough to appropriately communicate with the Investigator, Subinvestigator and clinical research coordinators, and who understood Japanese or English
Exclusion criteria
Exclusion criteria: Subjects meeting any of the following criteria will be excluded from this study: 1) Subjects with current or past history of significant disease such as cardiovascular, hematological, hemorrhagic, hepatic, renal, metabolic, endocrine, respiratory, gastrointestinal, urological, neurological, central nervous system or psychoneurological disease or allergic disease (with the exception of asymptomatic, untreated seasonal allergy at the time of screening examination) that is inappropriate for participation in the study in the opinion of the Investigator 2) Subjects who currently have any medical problem (requiring certain treatment or follow-up observation) in the opinion of the Investigator on the basis of physical examination and other examinations (except for centrally assessed ECG parameters) performed at screening, on the day before administration of the study drug, or at pre-dose on the day of administration of the study drug 3) Subjects with a risk factor for torsade de pointes, such as a family history of long QT syndrome or sudden death in immediate family members (ie, biological parents and siblings) 4) Subjects with a history of cardiac failure or hypokalemia 5) Subjects with screening 12-lead analog ECG demonstrating any of the following: heart rate (HR) 100 bpm, QRS > 100 msec, Fridericia-corrected QT interval (QTcF) > 450 msec, or PR > 200 msec 6) Subjects with a history of severe allergy or of allergy to two or more drugs. Subjects with a history of allergy to any ingredients in the study drug product. Subjects with known or suspected hypersensitivity to drugs. 7) Subjects who received another study drug while in another clinical trial within 90 days before administration of the study drug in the present study 8) Subjects who had been hospitalized within 45 days before administration of the study drug 9) Subjects who donated blood or blood components as follows: a) 400 mL or more blood within 90 days before administration of the study drug b) 200 mL or more blood within 30 days before administration of the study drug c) Blood components within 14 days before administration of the study drug 10) Subjects with a positive urine drug screen test at screening or with a positive immunology test at screening 11) Subjects who used any prescription drug or over-the-counter drug during a specified time period before administration of the study drug (ie, five elimination half-lives of the drug or 14 days, whichever is longer), or who are anticipated to require any drugs during the study period (except for drugs to treat adverse events) 12) Subjects who used any drugs that can induce drug-metabolizing enzymes within 30 days before administration of the study drug 13) Subjects who consumed St. John's wort-containing foods or beverages within 14 days before administration of the study drug 14) Subjects who consumed grapefruit-containing foods or beverages within 7 days before administration of the study drug 15) Subjects with known or suspected alcohol abuse 16) Subjects with high consumption of caffeine-containing beverages (e.g., coffee, black tea, green tea, cola, energy drinks) 17) Subjects with a history of tobacco dependence. Subjects who used tobacco or nicotine-containing products (eg, pipes, cigars, nicotine patches, chewing tobacco, nasal spray, inhaler, nicotine gum) within 30 days before screening examination 18) Subjects who do not tolerate venipuncture or have poor venous access that would cause difficulty for c
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety bioavailability pharmacokinetics other -To assess the safety and tolerability of a single oral dose of BBI608 in healthy Japanese male Volunteers - To assess QT/QTc interval prolongation effect of a single oral dose of BBI608 in healthy Japanese male volunteers and female volunteers - To assess the food effect on the pharmacokinetics of a single oral dose of BBI608 in healthy Japanese male volunteers - To assess the pharmacokinetics of a single oral dose of BBI608 in healthy non-Asian male volunteers | — |
Secondary
| Measure | Time frame |
|---|---|
| safety pharmacokinetics other - To assess the pharmacokinetics of a single oral dose of BBI608 in healthy Japanese male volunteers and female volunteers - To assess the safety and tolerability of a single oral dose of BBI608 in healthy Japanese male volunteers and female volunteers - To assess the safety and tolerability of a single oral dose of BBI608 in healthy non-Asian male volunteers. | — |
Countries
Japan
Outcome results
None listed