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 1RecruitingNCT07549919

AnnJi Pharmaceutical Co., Ltd.26 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy Male Adults Food Effect in Healthy Volunteers

Interventions

AJ201

Eligibility

Sex: MALEMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Plasma PK of AJ201

AUC0-24hr: Area under the concentration-time curve from zero to 24 hours under fasting and fed conditions

Time frame: Pre-dose to Day 6

Plasma PK of AJ201

AUC0-last: Area under the concentration-time curve from zero to the last observed concentration under fasting and fed conditions

Time frame: Pre-dose to Day 6

Plasma PK of AJ201

AUC0-inf: Area under the concentration-time curve from time zero to infinity (extrapolated) under fasting and fed conditions

Time frame: Pre-dose to Day 6

Plasma PK of AJ201

Cmax: Maximal observed concentration under fasting and fed conditions

Time frame: Pre-dose to Day 6

Plasma PK of AJ201

Tmax: Time when the maximal concentration is observed under fasting and fed conditions

Time frame: Pre-dose to Day 6

Plasma PK of AJ201

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

Time frame: Pre-dose to Day 6

Plasma PK of AJ201

Tlag: Time of observation prior to the first observation with a measurable (non-zero) concentration under fasting and fed conditions

Time frame: Pre-dose to Day 6

Plasma PK of AJ201

T½ el: Terminal elimination half-life under fasting and fed conditions

Time frame: Pre-dose to Day 6

Plasma PK of AJ201

Kel: Terminal elimination rate constant under fasting and fed conditions

Time frame: Pre-dose to Day 6

Plasma PK of AJ201

Cl/F: Apparent clearance under fasting and fed conditions

Time frame: Pre-dose to Day 6

Plasma PK of AJ201

Vz/F: Apparent volume of distribution under fasting and fed conditions

Time frame: Pre-dose to Day 6

Urine PK of AJ201

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

Time frame: Pre-dose to Day 7

Urine PK of AJ201

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

Time frame: Pre-dose to Day 7

Urine PK of AJ201

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

Time frame: Pre-dose to Day 7

Urine PK of AJ201

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

Time frame: Pre-dose to Day 7

Urine PK of AJ201

TRmax: Time of maximal urinary excretion, calculated as the midpoint of the collection interval during which Rmax occurred under fasting and fed conditions

Time frame: Pre-dose to Day 7

Urine PK of AJ201

ClR: Renal clearance, calculated as Ae0-24hr /AUC0-24hr under fasting and fed conditions

Time frame: Pre-dose to Day 7

Secondary Outcomes

Safety and Tolerability of AJ201

Incidence and proportion of volunteers with AEs, including TEAEs and SAEs

Time frame: Baseline to Day 12

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts