Clinical Pharmacology Study of AK1830 (Drug-Drug Interaction Study in Healthy Men)

JRCT ID: jRCT2051200119

Registered date:22/01/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: healthy subjects
• Date of first enrollment: 07/02/2021
• Target sample size: 20
• Study type: Interventional
• Intervention(s): AK1830 oral administration and blood collection

Outcome(s)

• Primary Outcome: Plasma concentration of compound(s)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 44age old
• Gender: Male

Include criteria

The subjects will be individuals who meet all of the following criteria.
[1] Healthy men
[2] Individuals >=20 to <45 years of age at the time of informed consent
[3] Individuals who fully understand the details of the study and who are capable of providing written informed consent

Exclude criteria

Individuals meeting any of the following criteria will be excluded from the study.
[1] Past history of disease of kidney, liver, heart, brain, or other conditions considered unsuitable for this study
[2] Past history of disease or surgery that could affect absorption of the investigational product or designated concomitant drug
[3] Other protocol defined exclusion criteria could apply

Related Information

• Primary Sponsor: Shimizu Tomohito