AKP-009 additional Phase I clinical trial

JRCT ID: jRCT2071210062

Registered date:22/09/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Benign prostatic hyperplasia
• Date of first enrollment: 12/10/2021
• Target sample size: 45
• Study type: Interventional

Intervention(s)

Single dosing group: single oral administration of 80mg or 120mg of AKP-009 or Placebo
Multiple dosing group: Multiple oral administration of 20 or 30mg of AKP-009 or Placebo once daily for 10 days

Outcome(s)

Primary Outcome

Pharmacokinetics : AKP-009 plasma concentrations and pharmacokinetic parameter described below
Cmax, AUC0-t. AUC0-inf, Tmax, half life, MRT0-t, MRT0-inf, ramdaZ, CL/F, Vd/F, AUC0-tau, Ctrough
Safety: medical examinations, physical findings, electrocardiography, laboratory tests, endocrinological tests, adverse events

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Male

Include criteria

-The subjects are capable of understanding the requirements of this protocol and of providing voluntary written informed consent for participation in this study.
-Japanese healthy adult male aged 65 years or older in the multiple-dose 20 mg-H group and 20 years through 40 years in the other groups at the time of informed consent
-Subjects with a BMI of 18.5 or higher and < 25.0 (rounded down at the second decimal place)at the time of screening
-Subjects appropriate for the study as determined by principal investigator or sub-investigator (hereinafter, "Investigators") based on screening tests

Exclude criteria

-Subjects with a pre-existing or a history of liver disorder, renal disorder, cerebro-cardiovascular disease, gastrointestinal disorder, hematologic disorder, endocrine disease, or other disease that would be inappropriate for this study
-Subjects with tendency of drug allergy
-Subjects with a pre-existing or history of epilepsy or other convulsive disease
-Subjects with a pre-existing or history of alcohol dependence
-Subjects with a positive test result for drugs of abuse at the screening test
-Subjects whose HBs-antigen, HCV-antibody, HIV antigen/antibody, or serologic test for syphilis is positive at the time of screening
-Subjects whose body weight is <50 kg at the time of screening
-Subjects undergoing blood draw exceeding 200 mL within 4 weeks or 400 mL within 12 weeks prior to the start of dose in this study, or subjects undergoing pheresis within 2 weeks prior to the start of dose in this study
-Subjects inappropriate to take part in this study based on the status of drug use within 1 week prior to the start of dose in this study as determined by the investigators
-Subjects who have taken part in other clinical study within 16 weeks before the start of treatment in this study (but within 12 weeks if the investigational product is already approved)
-Subjects who received the first dose of vaccination for prevention of new coronavirus infection (COVID-19) within the 2 weeks prior to the screening test
-Subjects who is otherwise inappropriate for the study as determined by the investigators

Related Information

• Primary Sponsor: Shimomiya Kazuhiro