NCT07549919 · AnnJi Pharmaceutical Co., Ltd.
A Study to Evaluate the Effect of Food on the Bioavailability of AJ201, and Safety, Tolerability, and Pharmacokinetics of AJ201 in Japanese and White Healthy Male Participants
What this study is about
This is a Phase 1, randomly assigned, single-dose, where both patients and doctors know the treatment given, two-way crossover study to evaluate the effect of food on AJ201, and to evaluate the safety, tolerability, and how the drug moves through the body of AJ201 in Japanese and White healthy male participants.
View original scientific description
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.
Interventions
DRUG
AJ201
All participants are planned to be administered a single dose of AJ201 for each period (fed and fasted).
Primary outcome measures
Plasma PK of AJ201
Time frame: Pre-dose to Day 6
AUC0-24hr: Area under the concentration-time curve from zero to 24 hours under fasting and fed conditions
Plasma PK of AJ201
Time frame: Pre-dose to Day 6
AUC0-last: Area under the concentration-time curve from zero to the last observed concentration under fasting and fed conditions
Plasma PK of AJ201
Time frame: Pre-dose to Day 6
AUC0-inf: Area under the concentration-time curve from time zero to infinity (extrapolated) under fasting and fed conditions
Plasma PK of AJ201
Time frame: Pre-dose to Day 6
Cmax: Maximal observed concentration under fasting and fed conditions
Plasma PK of AJ201
Time frame: Pre-dose to Day 6
Tmax: Time when the maximal concentration is observed under fasting and fed conditions
Plasma PK of AJ201
Time frame: Pre-dose to Day 6
Residual area: Percentage of AUC0-inf due to extrapolation from the time of the last observed concentration to infinity, calculated as \[1 - (AUC0-last/AUC0-inf)\] x 100 under fasting and fed conditions
Plasma PK of AJ201
Time frame: Pre-dose to Day 6
Tlag: Time of observation prior to the first observation with a measurable (non-zero) concentration under fasting and fed conditions
Plasma PK of AJ201
Time frame: Pre-dose to Day 6
T½ el: Terminal elimination half-life under fasting and fed conditions
Plasma PK of AJ201
Time frame: Pre-dose to Day 6
Kel: Terminal elimination rate constant under fasting and fed conditions
Plasma PK of AJ201
Time frame: Pre-dose to Day 6
Cl/F: Apparent clearance under fasting and fed conditions
Plasma PK of AJ201
Time frame: Pre-dose to Day 6
Vz/F: Apparent volume of distribution under fasting and fed conditions
Urine PK of AJ201
Time frame: Pre-dose to Day 7
Ae0-24hr: Cumulative urinary excretion from time zero to 24 hours, calculated as the sum of the amounts excreted over each collection interval under fasting and fed conditions
Urine PK of AJ201
Time frame: Pre-dose to Day 7
Ae0-48hr: Cumulative urinary excretion from time zero to 48 hours, calculated as the sum of the amounts excreted over each collection interval under fasting and fed conditions
Urine PK of AJ201
Time frame: Pre-dose to Day 7
Ae0-last: Cumulative urinary excretion from time zero to the last observed concentrations, calculated as the sum of the amounts excreted over each collection interval under fasting and fed conditions
Urine PK of AJ201
Time frame: Pre-dose to Day 7
Rmax: Maximal rate of urinary excretion, calculated by dividing the amount of drug excreted in each collection interval by the time over which it was collected under fasting and fed conditions
Urine PK of AJ201
Time frame: Pre-dose to Day 7
TRmax: Time of maximal urinary excretion, calculated as the midpoint of the collection interval during which Rmax occurred under fasting and fed conditions
Urine PK of AJ201
Time frame: Pre-dose to Day 7
ClR: Renal clearance, calculated as Ae0-24hr /AUC0-24hr under fasting and fed conditions
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
- 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 ≤ 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.
Where
- Los Alamitos, California
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 24, 2026 · Source of record for eligibility and locations