This is a Phase 1, randomized, single-dose, open-label, two-way crossover study to evaluate the effect of food on AJ201, and to evaluate the safety, tolerability, and pharmacokinetics of AJ201 in Japanese and White healthy male participants.
Male, non-smokers (no use of tobacco or nicotine products within 3 months prior to Screening), ≥ 18 and ≤ 55 years of age, with body mass index (BMI) ≥ 18.5 and ≤ 30.0 kg/m2 and body weight ≥ 50.0 kg.
Normal renal function at Screening.
The absence of clinically significant illness and surgery within 4 weeks prior to study drug administration.
The absence of a clinically significant history of neurological, endocrine, cardiovascular, respiratory, hematological, immunological, psychiatric, depression, attempted suicide, gastrointestinal, renal, hepatic, and metabolic disease.
Any clinically significant abnormal finding at physical examination.
Clinically significant abnormal laboratory test results or positive serology test results for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) antigen and antibody, at Screening.
Positive urine drug screen, urine cotinine test, or alcohol breath test.
History of significant allergic reactions to any drug.
Crossover
AJ201
DrugAll participants are planned to be administered a single dose of AJ201 for each period (fed and fasted).
Plasma PK of AJ201
AUC0-24hr: Area under the concentration-time curve from zero to 24 hours under fasting and fed conditions
Plasma PK of AJ201
AUC0-last: Area under the concentration-time curve from zero to the last observed concentration under fasting and fed conditions
Plasma PK of AJ201
AUC0-inf: Area under the concentration-time curve from time zero to infinity (extrapolated) under fasting and fed conditions
Plasma PK of AJ201
Cmax: Maximal observed concentration under fasting and fed conditions
Safety and Tolerability of AJ201
Incidence and proportion of volunteers with AEs, including TEAEs and SAEs
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