AKP-009 Phase I clinical trial

JRCT ID: jRCT2071230052

Registered date:23/08/2023

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Benign prostatic hyperplasia
• Date of first enrollment: 19/09/2023
• Target sample size: 81
• Study type: Interventional

Intervention(s)

Single-dose groups: single oral dose of AKP-009 (5 mg, 10 mg, 20 mg, 40 mg, 80 mg, 160 mg or 240 mg) or placebo
Multiple-dose groups: multiple oral doses of AKP-009 (5 mg, 10 mg, 20 mg or 40 mg) or placebo once daily for 10 days

Outcome(s)

• Primary Outcome: Pharmacokinetics and safety

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 85age old
• Gender: Male

Include criteria

- 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

Exclude criteria

- 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

Related Information

• Primary Sponsor: Shimomiya Kazuhiro