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Tests treatment safety and results for Healthy Male Adults
Official title 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
ClinicalTrials.gov ID: NCT07549919
What this study is testing
What is AJ201?
AJ201 is an investigational medicine, being studied as a potential treatment for healthy male adults.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 55, men only. Healthy volunteers may be eligible.
You may be able to join if
- 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)...
- 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...
You likely can't join if
- 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...
- 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.
See the full eligibility 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...
- Participants must be either Japanese or White.
- Able to understand the study procedures and provide signed informed consent to participate in the study. Key
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Los Alamitos, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years to 55 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Alamitos, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.