A Pharmacokinetic Trial of the OPB-111077 Current Formulation Versus the Modified Formulation by Single Administration in Healthy Adult Male Subjects

JRCT ID: jRCT2071230033

Registered date:27/06/2023

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Diffuse large B-cell lymphoma
• Date of first enrollment: 30/08/2023
• Target sample size: 56
• Study type: Interventional

Intervention(s)

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. At 30 minutes (acceptable window: 25 to 30 minutes) after the start of breakfast, a single oral dose of the IMP scheduled for each cohort and group will be administered with approximately 150 mL of water.
The dose for Cohort 1 is 100 mg for the current formulation and 50 mg for the modified formulation and while confirming the tolerability and safety of each of the current and modified formulations, the sponsor will decide whether to proceed to the next cohort based on the procedure for advancing to the next cohort.
The dose of the current formulation in Cohort 2 and Cohort 3 is 200 mg and 400mg. The sponsor will determine the dose of the modified formulation to be administered in Cohort 2 and Cohort 3 based on the pharmacokinetic data for the unchanged drug up until 96 hours postdose.

Outcome(s)

Primary Outcome

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)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 40age old
• Gender: Male

Include 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

Exclude 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

Related Information

• Primary Sponsor: Sanada Nobuhito