Mass Balance Study in Healthy Subjects
Conditions
Brief summary
Mass Balance Study of \[14C\]JAB-21822 in China Healthy Subjects
Detailed description
A phase I study to quantify the total mass balance in healthy subjects after a single dose of \[14C\]JAB-21822
Interventions
DRUG[14C]JAB-21822
Single oral administration of Carbon-14 labeled JAB-21822 800 mg/100 μCi on empty stomach
Sponsors
Allist Pharmaceuticals, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy male subjects between the ages of 18 and 45 years (inclusive). 2. Subjects weighing ≥ 50 kg and Body Mass Index of 19.0 to 26.0 kg/m2. 3. Subjects who have voluntarily participated in the study and signed the informed consent form with good compliance.
Exclusion criteria
1. With abnormal and clinically significant comprehensive physical examinations, vital signs, or laboratory examinations. 2. Has a positive test for HBV, HCV, HIV, or syphilis. 3. Known medical history judged by the investigator as not suitable for the study. 4. Known history of drug or food allergy. 5. Has drug or alcohol abuse history or positive drug or alcohol abuse test results. 6. Heavy smokers or caffeine addicts. 7. Has diseases or other conditions affecting the absorption, distribution, metabolism, and excretion of oral drugs. 8. Disagree to strict contraception within one year after the trial 9. Has any other conditions judged by the investigator as not suitable for the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Whole blood to plasma total radioactivity ratio | up to 504 hours post dose | — |
| Total radioactivity in plasma PK: Cmax | up to 504 hours post dose | Highest radioactivity observed plasma concentration |
| Total radioactivity in plasma PK: Area under the curve | up to 504 hours post dose | Area under the plasma concentration time curve |
| Total radioactivity in plasma PK: t1/2 | up to 504 hours post dose | Elimination half-life |
| Total radioactivity in plasma PK: MRT | up to 504 hours post dose | Mean residence time |
| Total radioactivity in plasma PK: Tmax | up to 504 hours post dose | Time for Cmax |
| Percentage of radioactivity and identification of metabolites in plasma, urine and fecal samples | up to 504 hours post dose | Percentage of prototype drugs and its metabolites in plasma, urine and fecal samples. Identification of the major metabolites |
| Recovery of total radioactivity in urine and fecal samples | up to 504 hours post dose | Mass balance recovery of total radioactivity in urine and fecal samples |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| JAB-21822 PK: Area under the curve | up to 504 hours post dose | Area under the plasma concentration time curve of JAB-21822 |
| JAB-21822 PK: t1/2 | up to 504 hours post dose | Elimination half-life of JAB-21822 |
| JAB-21822 PK: MRT | up to 504 hours post dose | Mean residence time of JAB-21822 |
| JAB-21822 PK: Tmax | up to 504 hours post dose | Time for Cmax of JAB-21822 |
| Number of participants with adverse events | up to 504 hours post dose | 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 |
| JAB-21822 PK: Cmax | up to 504 hours post dose | Highest observed plasma concentration of JAB-21822 |
Countries
China
Outcome results
None listed