AKP-009 Phase I clinical trial
- Conditions
- Benign prostatic hyperplasia
- Registration Number
- JPRN-jRCT2071230052
- Lead Sponsor
- Shimomiya Kazuhiro
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Male
- Target Recruitment
- 81
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pharmacokinetics and safety
- Secondary Outcome Measures
Name Time Method