Diffuse large B-cell lymphoma
Conditions
Interventions
A single oral dose of an antiemetic drug (Nasea OD Tablets 0.1 mg) will be administered at 1 hour (acceptable window: 55 to 60 minutes) prior to IMP administration with approximately 150 mL of water.
Sponsors
Sanada Nobuhito
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) Japanese males at least 18 years of age and below the age of 40 at the time of informed consent 2) Subjects with a body mass index (BMI) between 18.5 and 25.0 kg/m2 (inclusive) at screening 3) Subjects who are able to provide personally-signed informed consent prior to initiation of any trial-related procedures and who are judged by the investigator or subinvestigator to be capable of meeting all of the requirement of the trial
Exclusion criteria
Exclusion criteria: 1) Subjects with clinically significant abnormalities in the screening examination or in their medical history that could potentially pose a risk to the subject or affect such endpoints as the absorption, distribution, metabolism, or excretion of the drug as judged by the investigator or subinvestigator 2) Subjects who fall under any of the following criteria for hepatitis -Subjects with a history or current symptoms of hepatitis B or current symptoms of hepatitis C, or who test positive for hepatitis B surface (HBs) antigen or hepatitis C virus (HCV) antibody at screening -Subjects with a history or current symptoms of alcoholic hepatitis or nonalcoholic steatohepatitis 3) Subjects who have acquired immunodeficiency syndrome (AIDS) or a history of human immunodeficiency virus (HIV) infection, who test positive for HIV or syphilis at screening, or who have a positive polymerase chain reaction (PCR) test for SARS coronavirus 2 (SARS-CoV-2) at screening and at pre-admission) 4) Subjects with a history or complication of a serious mental disorder 5) Subjects with a history or complication of diabetes mellitus
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety endpoints: clinical laboratory tests (hematology, bloodchemistry, urinalysis, blood gas test [venous]), physical examination findings,vital signs (blood pressure, pulse rate, body temperature),12-lead Electrocardiogram(ECG),body weight, Adverse Events(AEs) Pharmacokinetic endpoints: Plasma drug concentrations and pharmacokinetic parameters (OPB-111077 and its metabolites) | — |
Contacts
Public ContactDrug Information Center
Otsuka Pharmaceutical Co., LTD.
Outcome results
None listed