Mass Balance Study of [14C]JAB-21822 in China Healthy Subjects
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Allist Pharmaceuticals, Inc.
- Enrollment
- 6
- Locations
- 1
- Primary Endpoint
- Recovery of total radioactivity in urine and fecal samples
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
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/m
- •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.
Arms & Interventions
[14C]JAB-21822
Single oral dose of 800mg 14C]JAB-2182 suspension
Intervention: [14C]JAB-21822 (Drug)
Outcomes
Primary Outcomes
Recovery of total radioactivity in urine and fecal samples
Time Frame: up to 504 hours post dose
Mass balance recovery of total radioactivity in urine and fecal samples
Total radioactivity in plasma PK: Cmax
Time Frame: up to 504 hours post dose
Highest radioactivity observed plasma concentration
Percentage of radioactivity and identification of metabolites in plasma, urine and fecal samples
Time Frame: up to 504 hours post dose
Percentage of prototype drugs and its metabolites in plasma, urine and fecal samples. Identification of the major metabolites
Total radioactivity in plasma PK: MRT
Time Frame: up to 504 hours post dose
Mean residence time
Total radioactivity in plasma PK: Tmax
Time Frame: up to 504 hours post dose
Time for Cmax
Total radioactivity in plasma PK: Area under the curve
Time Frame: up to 504 hours post dose
Area under the plasma concentration time curve
Total radioactivity in plasma PK: t1/2
Time Frame: up to 504 hours post dose
Elimination half-life
Whole blood to plasma total radioactivity ratio
Time Frame: up to 504 hours post dose
Secondary Outcomes
- JAB-21822 PK: Tmax(up to 504 hours post dose)
- JAB-21822 PK: Area under the curve(up to 504 hours post dose)
- JAB-21822 PK: t1/2(up to 504 hours post dose)
- JAB-21822 PK: Cmax(up to 504 hours post dose)
- JAB-21822 PK: MRT(up to 504 hours post dose)
- Number of participants with adverse events(up to 504 hours post dose)