Phase I study to investigate the pharmacokinetics, food effect, and safety of AKP-009 after single and multiple oral doses

ASKA Pharmaceutical Co., Ltd.0 个研究点目标入组 81 人开始时间: 待定最近更新: 2024年3月28日

适应症

试验速览

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•Individuals who are capable of understanding the nature of the study and can provide written voluntary consent to participate in the study
•Healthy adult Japanese men 65 to 85 years of age (inclusive) at the time of informed consent for the multiple-dose 20 mg-H group, and healthy adult Japanese men 20 to 40 years of age (inclusive) at the time of informed consent for the other groups
•Individuals with a BMI of >= 18.5 and <= 25.0 at screening

•Individuals with current or previous disease considered inappropriate for participation in the study, such as liver disorders, kidney disorders, cerebrovascular/cardiovascular disorders, gastrointestinal disorders, blood diseases, or endocrine diseases
•Individuals with drug allergy
•Individuals with current or previous convulsive disorder such as epilepsy
•Individuals with current or previous alcoholism
•Individuals who test positive for drug abuse at screening
•Individuals who test positive for HBs antigen, HCV antibody, HIV antigen/antibody, or serological syphilis at screening
•Individuals who weigh less than 50 kg at screening
•Individuals from whom at least 200 mL or 400 mL of blood had been collected within 4 or 12 weeks before study treatment, respectively, or who had donated blood component within 2 weeks before study treatment
•Individuals who are considered by the investigator/subinvestigator to be unsuitable for participation in the study based on the medication status within 1 week before study treatment
•Individuals who had participated in another clinical trial within 16 weeks before study treatment

Pharmacokinetics and safety

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发起方