Mass Balance Study of [14C]JAB-21822

Study Overview
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Brief Summary
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Mass Balance Study of [14C]JAB-21822 in China Healthy Subjects

Detailed Description
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A phase I study to quantify the total mass balance in healthy subjects after a single dose of [14C]JAB-21822

Official Title
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Mass Balance Study of [14C]JAB-21822 in China Healthy Subjects

Conditions
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Mass Balance Study in Healthy Subjects

Intervention / Treatment
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* Drug: [14C]JAB-21822


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male subjects between the ages of 18 and 45 years (inclusive). Subjects weighing ≥ 50 kg and Body Mass Index of 19.0 to 26.0 kg/m2. Subjects who have voluntarily participated in the study and signed the informed consent form with good compliance. Exclusion Criteria: With abnormal and clinically significant comprehensive physical examinations, vital signs, or laboratory examinations. Has a positive test for HBV, HCV, HIV, or syphilis. Known medical history judged by the investigator as not suitable for the study. Known history of drug or food allergy. Has drug or alcohol abuse history or positive drug or alcohol abuse test results. Heavy smokers or caffeine addicts. Has diseases or other conditions affecting the absorption, distribution, metabolism, and excretion of oral drugs. Disagree to strict contraception within one year after the trial Has any other conditions judged by the investigator as not suitable for the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: [14C]JAB-21822<br>Single oral dose of 800mg 14C]JAB-2182 suspension | Drug: [14C]JAB-21822<br>* Single oral administration of Carbon-14 labeled JAB-21822 800 mg/100 μCi on empty stomach<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recovery of total radioactivity in urine and fecal samples | Mass balance recovery of total radioactivity in urine and fecal samples | up to 504 hours post dose | 
| Total radioactivity in plasma PK: Cmax | Highest radioactivity observed plasma concentration | up to 504 hours post dose | 
| Total radioactivity in plasma PK: Area under the curve | Area under the plasma concentration time curve | up to 504 hours post dose | 
| Total radioactivity in plasma PK: t1/2 | Elimination half-life | up to 504 hours post dose | 
| Total radioactivity in plasma PK: MRT | Mean residence time | up to 504 hours post dose | 
| Total radioactivity in plasma PK: Tmax | Time for Cmax | up to 504 hours post dose | 
| Percentage of radioactivity and identification of metabolites in plasma, urine and fecal samples | Percentage of prototype drugs and its metabolites in plasma, urine and fecal samples. Identification of the major metabolites | up to 504 hours post dose | 
| Whole blood to plasma total radioactivity ratio |  | up to 504 hours post dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| JAB-21822 PK: Cmax | Highest observed plasma concentration of JAB-21822 | up to 504 hours post dose | 
| JAB-21822 PK: Area under the curve | Area under the plasma concentration time curve of JAB-21822 | up to 504 hours post dose | 
| JAB-21822 PK: t1/2 | Elimination half-life of JAB-21822 | up to 504 hours post dose | 
| JAB-21822 PK: MRT | Mean residence time of JAB-21822 | up to 504 hours post dose | 
| JAB-21822 PK: Tmax | Time for Cmax of JAB-21822 | up to 504 hours post dose | 
| Number of participants with adverse events | All subjects will be assessed for incidence and severity of adverse events (AEs) and serious AEs, including changes in laboratory values, vital signs, electrocardiograms and ophthalmological assessments | up to 504 hours post dose |