ONO-4059 relative bioavailability comparative study

JRCT ID: jRCT2071230119

Registered date:28/02/2024

Basic Information

• Recruitment status: Complete

Health condition(s) or Problem(s) studied

Primary central nervous system lymphoma
Primary macroglobulinemia
Lymphoplasmacytic lymphoma

• Date of first enrollment: 27/03/2024
• Target sample size: 24
• Study type: Interventional
• Intervention(s): 480mg of ONO-4059 will be oraly administered with fasted condition

Outcome(s)

Primary Outcome

- Relative bioavailability
Using the administration of the test product as the test group and the administration of the reference product as the control group, the geometric mean ratios and their 90% confidence intervals for Cmax and AUClast of ONO-4059 will be calculated and used to evaluate the relative bioavailability.

Secondary Outcome

- Safety
Adverse events and adverse drug reactions, lab. test (hematology, blood chemistry, coagulation, and urinalysis), vital signs (blood pressure / pulse rate, SpO2, body temperature)
- Pharmacokinetics
Summary statistics of plasma concentration and pharmacokinetic parameters (Cmax, Tmax, AUClast, AUCinf, T1/2, CL/F, kel, MRT) will be calculated for each formulation.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 45age old
• Gender: Male

Include criteria

1. Healthy Japanese adult males
2. The subject is aged 18 to 45 years, inclusive, at the time of signing the informed consent form.
3. The subject has a BMI of 18.5 kg/m2 or more and less than 25.0 kg/m2 (rounded down to one decimal place) at Screening.
4. Subjects who agree to use contraceptive from the start of the study drug administration to 7 days after the last dose of the study drug
5. Subject who understands the details of the study and has given written informed consent to participate in the study.

Exclude criteria

1. Those who are receiving treatment or have a history of these in the respiratory system, cardiovascular system, psychiatric system, nervous system, gastrointestinal system, immune system, liver, kidney, hematopoietic function, endocrine function, etc. (History of malignancy within 5 years before admission)
2. The subject has a disease (Asthma, Crohn's disease, etc.) that requires systemic steroids.
3. The subject has an active infection (excluding superficial mycosis).
4. The subject has a history of serious recurrent infection or chronic infection.
5. The subject has received an antibiotic infusion or has an infection requiring hospitalization within 56 days prior to hospitalization.
6. The subject has received oral antibiotics within 14 days prior to admission.
7. The subject has a history of bacteremia caused by Staphylococcus aureus or Pseudomonas aeruginosa within 1 year prior to hospitalization.
This does not apply to patients who have received treatment and are cured.)
8. The subject had a bone and soft tissue infection within 1 year prior to admission.
9. The subject has undergone surgery (excluding biopsy) within 28 days prior to admission.
10. The subject has a history of serious infection while on immunosuppressant therapy (Grade 4 or higher according to NCI-CTCAE v5.0)

Related Information

• Primary Sponsor: Namba Yoshinobu