Food Effect in Healthy Volunteers, Healthy Male Adults
Conditions
Keywords
Healthy Male Adults, Healthy Volunteers, Food Effect
Brief 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.
Interventions
DRUGAJ201
All participants are planned to be administered a single dose of AJ201 for each period (fed and fasted).
Sponsors
AnnJi Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Tolerability of AJ201 | Baseline to Day 12 | Incidence and proportion of volunteers with AEs, including TEAEs and SAEs |
Countries
United States
Contacts
CONTACTAndy Chen, PhD
Outcome results
None listed