Clinical Trials in the USA / NCT07549919
Recruiting
Phase 1
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
NCT07549919 · tracked via the Priya Life Science USA tracker
Condition(s) studied
Healthy Male AdultsFood Effect in Healthy Volunteers
Investigational drug(s) / intervention(s)
AJ201
AJ201: All participants are planned to be administered a single dose of AJ201 for each period (fed and fasted).
Study summary
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.
Eligibility
Key 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.
Primary outcome measure(s)
- Plasma PK of AJ201 — 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 — 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 — 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 — Pre-dose to Day 6
Cmax: Maximal observed concentration under fasting and fed conditions - Plasma PK of AJ201 — Pre-dose to Day 6
Tmax: Time when the maximal concentration is observed under fasting and fed conditions - Plasma PK of AJ201 — 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 — 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 — Pre-dose to Day 6
T½ el: Terminal elimination half-life under fasting and fed conditions - Plasma PK of AJ201 — Pre-dose to Day 6
Kel: Terminal elimination rate constant under fasting and fed conditions - Plasma PK of AJ201 — Pre-dose to Day 6
Cl/F: Apparent clearance under fasting and fed conditions - Plasma PK of AJ201 — Pre-dose to Day 6
Vz/F: Apparent volume of distribution under fasting and fed conditions - Urine PK of AJ201 — 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 — 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 — 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 — 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 — 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 — Pre-dose to Day 7
ClR: Renal clearance, calculated as Ae0-24hr /AUC0-24hr under fasting and fed conditions
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| AnnJi Investigational Site | Los Alamitos | California | Recruiting |
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07549919 on ClinicalTrials.gov ↗ ← All trials in the USA