Clinical trial NCT05920941: Mass Balance Study of [14C]JAB-21822
Official title: Mass Balance Study of [14C]JAB-21822 in China Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Mass Balance Study in Healthy Subjects
Lead sponsor: Allist Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2023-06-27
Enrollment: 6
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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

Eligibility criteria: 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.

Primary outcomes:
measure: Recovery of total radioactivity in urine and fecal samples
timeFrame: up to 504 hours post dose
measure: Total radioactivity in plasma PK: Cmax
timeFrame: up to 504 hours post dose
measure: Total radioactivity in plasma PK: Area under the curve
timeFrame: up to 504 hours post dose
measure: Total radioactivity in plasma PK: t1/2
timeFrame: up to 504 hours post dose
measure: Total radioactivity in plasma PK: MRT
timeFrame: up to 504 hours post dose
measure: Total radioactivity in plasma PK: Tmax
timeFrame: up to 504 hours post dose
measure: Percentage of radioactivity and identification of metabolites in plasma, urine and fecal samples
timeFrame: up to 504 hours post dose
measure: Whole blood to plasma total radioactivity ratio
timeFrame: up to 504 hours post dose
Secondary outcomes:
measure: JAB-21822 PK: Cmax
timeFrame: up to 504 hours post dose
measure: JAB-21822 PK: Area under the curve
timeFrame: up to 504 hours post dose
measure: JAB-21822 PK: t1/2
timeFrame: up to 504 hours post dose
measure: JAB-21822 PK: MRT
timeFrame: up to 504 hours post dose
measure: JAB-21822 PK: Tmax
timeFrame: up to 504 hours post dose
measure: Number of participants with adverse events
timeFrame: up to 504 hours post dose
Other outcomes:
Locations:
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University
state: Jiangsu
Study officials:
affiliation: The First Affiliated Hospital of Soochow University
name: Miao Liyan doctor of pharmacy
role: PRINCIPAL_INVESTIGATOR
References: