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Recruiting NCT07549919

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

Phase I Interventional Healthy Male Adults Food Effect in Healthy Volunteers

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: AJ201.
Who it may be relevant to
Registry conditions: Healthy Male Adults, Food Effect in Healthy Volunteers. Basic parameters: 18 years — 55 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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]
  • Plasma PK of AJ201 [Time frame: Pre-dose to Day 6]
  • Plasma PK of AJ201 [Time frame: Pre-dose to Day 6]
  • Plasma PK of AJ201 [Time frame: Pre-dose to Day 6]
  • Plasma PK of AJ201 [Time frame: Pre-dose to Day 6]
  • Plasma PK of AJ201 [Time frame: Pre-dose to Day 6]
  • Plasma PK of AJ201 [Time frame: Pre-dose to Day 6]
  • Plasma PK of AJ201 [Time frame: Pre-dose to Day 6]
  • Plasma PK of AJ201 [Time frame: Pre-dose to Day 6]
  • Plasma PK of AJ201 [Time frame: Pre-dose to Day 6]
Secondary outcome measures (1)
  • Safety and Tolerability of AJ201 [Time frame: Baseline to Day 12]

Eligibility criteria

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.

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • AnnJi Investigational Site — Los Alamitos

Identifiers

NCT: NCT07549919 · JM17-201-102

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗