๐ฌIn plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
Key Inclusion Criteria:
* Male, non-smokers (no use of tobacco or nicotine products within 3 months prior to Screening), โฅ 18 and โค 55 years of age, with body mass index (BMI) โฅ 18.5 and โค 30.0 kg/m2 and body weight โฅ 50.0 kg.
* Normal renal function at Screening.
* Healthy as defined by:
* 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.
* Participants must be either Japanese or White.
* Able to understand the study procedures and provide signed informed consent to participate in the study.
Key Exclusion Criteria:
* 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.
* Clinically significant ECG abnormalities or vital signs abnormalities at Screening.
* History of drug abuse of any soft drugs or hard drugs.
* History of alcohol abuse.
* History of smoking or uses other nicotine-containing products.
* Undergone major surgery โค 3 months before first study drug administration.
* History of clinically significant opportunistic infection or serious local infection or significant medical/surgical procedure or trauma or any current infection.
* Use of medications for the timeframes specified in the protocol.
* Presence of orthodontic braces or orthodontic retention wires, or any physical findings in the mouth or tongue that would interfere with the dosing procedure.