臨床研究等提出・公開システム

A Phase I, Randomized, Single-Center, Double-Blind, Placebo-Controlled Study to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics of a Single Dose of AKP-021 in Healthy Male Adults

Phase I Clinical Study of AKP-021 in Healthy Male Adults

Sawae Juichi

ASKA Pharmaceutical Co., Ltd.

2-5-1, Shibaura, Minato-ku, Tokyo, Japan

aska-clinical@aska-pharma.co.jp

Sawae Juichi

ASKA Pharmaceutical Co., Ltd.

2-5-1, Shibaura, Minato-ku, Tokyo, Japan

+81-90-3644-6645

aska-clinical@aska-pharma.co.jp

Complete

Feb. 03, 2025

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

other

1)Capable of understanding the details of the study and can provide written voluntary consent to participate in the study
2)Healthy Japanese male adult aged >=18 years and <=40 years at the time of informed consent
3)BMI >=18.5 and <25.0 at screening tests
4)A participant who has undergone screening and is deemed suitable as a participant in this study by the investigator

1)Current or previous diseases considered unsuitable for this study, such as liver disorders, renal disorders, cerebral cardiovascular disorders, gastrointestinal disorders, hematological disorders, and endocrine disorders.
2)Allergic predisposition to a drug or food
3)Current or previous convulsive disorder such as epilepsy
4)Alcohol dependence or history of alcohol dependence
5)Positive drug abuse test result at the screening tests
6)Positive for HBs antigen, HCV antibody, HIV antigen/antibody, or serologic test for syphilis at the screening tests
7)Body weight <50 kg at the screening tests
8)At least 200 mL or 400 mL of blood has been collected within 4 or 12 weeks before receiving the investigational product, respectively, or blood components have been donated within 2 weeks before receiving the investigational product
9)Use of medications within 1 week prior to dosing of the investigational product that the investigator deems to be unsuitable for participation in the study
10)Participated in another clinical study in which an investigational product was received within 16 weeks (or within 12 weeks for an approved investigational product) prior to dosing of the investigational product
11)Any other person who is deemed by the investigator to be unsuitable as a participant in this study or those who are deemed ineligible for this study to be conducted by the investigator due to the possibility of an increased risk associated with participation in the study or the possibility of affecting the interpretation of the results of the study

Male

Healthy adult subjects

The investigational product will be taken (orally) with 200 mL of water after meals.
Part A: Two AKP-021-5mg tablets or AKP-021-placebo tablets per time
Part B: 4 to 8 AKP-021-5mg tablets or AKP-021-placebo tablets per time (the number of tablets is to be adjusted to achieve the determined dose)

Safety: Adverse events, physical findings (medical examination and body weight), vital signs (blood pressure, pulse rate, and body temperature), standard 12-lead electrocardiogram (ECG), and laboratory tests
Pharmacokinetics: Plasma AKP-021 concentration, urinary AKP-021 excretion, plasma AKP-021 metabolite (AKP-021-O-glucuronic acid conjugate) concentration, and pharmacokinetic parameters
Pharmacodynamics: LPS-induced PGE2 concentration in blood sample

+81-92-283-7701

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