Benign prostatic hyperplasia
Conditions
Interventions
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 pl
Sponsors
Shimomiya Kazuhiro
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion 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
Exclusion criteria
Exclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics and safety | — |
Contacts
Public ContactKazuhiro Shimomiya
ASKA Pharmaceutical Co., Ltd.
Outcome results
None listed