Single Administration study of Bomedemstat (MK-3543) in Healthy Japanese

JRCT ID: jRCT2071230096

Registered date:25/11/2023

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Essential thrombocythaemia
• Date of first enrollment: 09/01/2024
• Target sample size: 45
• Study type: Interventional
• Intervention(s): Treatment of MK-3543

Outcome(s)

• Primary Outcome: MK-3543 PK
• Secondary Outcome: Adveres event

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 64age old
• Gender: Both

Include criteria

1) Be in good health based on medical history, physical examination, vital sign measurements, 12-lead ECGs at the Screening Visit and before administration of the dose of the study intervention.
2) BMI >= 18.5 and <= 32.0 kg/m2, inclusive, with a body weight >= 50 and <= 100 kg.
3) Is an individual of any sex/gender, from 18 years to 64 years of age inclusive, at the time of providing the informed consent.

Exclude criteria

1) History of clinically significant endocrine, GI, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases.
2) History of cancer (malignancy).

Related Information

• Primary Sponsor: Fujita Tomoko