Healthy adult participants
Conditions
Interventions
1)5 mg single dose under fed condition (Healthy Japanese male): One AKP-021-5mg tablet or AKP-021-5mg placebo tablet per time
2)20 mg single dose under fed condition (Healthy Japanese male): Four AKP-
Sponsors
Sawae Juichi
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1)Capable of understanding the details of the study and can provide written voluntary consent to participate in the study 2)Healthy Japanese and Caucasian male adult aged >=18 years and =18.5 and =18.5 and <30.0 for Caucasians)at screening tests 4)A participant who has undergone screening and is deemed suitable as a participant in this study by the investigator
Exclusion criteria
Exclusion criteria: 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)Positive for fecal occult blood or fecal occult blood test could not be performed at the screening tests 9)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 10)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 11)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 12)A participant who have previously dosed AKP-021 13)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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety: Adverse events, laboratory tests, vital signs, weight, standard 12-lead electrocardiogram, and Holter electrocardiography Pharmacokinetics: Plasma AKP-021 concentration, plasma AKP-021 metabolite (AKP-021-O-glucuronic acid conjugate) concentration, and pharmacokinetic parameters Pharmacodynamics: LPS-induced PGE2 concentration in blood sample | — |
Contacts
Public ContactJuichi Sawae
ASKA Pharmaceutical Co., Ltd.
Outcome results
None listed