Mass Balance Study of [14C]HLX208 in China Healthy Subjects
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 6
- Locations
- 1
- Primary Endpoint
- Mass balance recovery of total radioactivity in urine and fecal samples.
Study Overview
Brief Summary
Mass Balance Study of [14C]HLX208 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]HLX208.
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 18.0 to 32.0 kg/m
- •No sperm donation or fertility plan during the study and within 12 months after the end of the study.
- •Subjects who have voluntarily participated in the study and signed the informed consent form with good compliance.
Exclusion Criteria
- •Known history of drug or food allergy.
- •Known medical history judged by the investigator as not suitable for the study.
- •Has laboratory or physical examination abnormalities during the screening period.
- •Has a positive test for, HBV，HCV，HIV，or syphilis.
- •Has drug abuse history or positive drug abuse test results.
- •Has diseases affecting the absorption, distribution, metabolism, and excretion of oral drugs.
- •Has any other conditions judged by the investigator as not suitable for the study.
Arms & Interventions
[14C]HLX208
Single oral dose of 450mg [14C]HLX208 suspension.
Intervention: [14C]HLX208 (Drug)
Outcomes
Primary Outcomes
Mass balance recovery of total radioactivity in urine and fecal samples.
Time Frame: Up to 336 hours post dose.
Mass balance recovery of total radioactivity in urine and fecal samples.
Total radioactivity in plasma PK: Tmax
Time Frame: Up to 240 hours post dose.
Time for Cmax
Total rradioactivity in plasma PK: t1/2
Time Frame: Up to 240 hours post dose.
Elimination half-life.
Total radioactivity in plasma PK: Vz/F
Time Frame: Up to 240 hours post dose.
Apparent volume of distribution following oral administration.
Total radioactivity in plasma PK: Cmax
Time Frame: Up to 240 hours post dose.
Maximum plasma concentration
Total radioactivity in plasma PK: AUC0-t
Time Frame: Up to 240 hours post dose.
Area under the plasma concentration time profile from time 0 to time of the last quantifiable concentration.
Total radioactivity in plasma PK: AUC0-∞
Time Frame: Up to 240 hours post dose.
Area under the plasma concentration time profile from time 0 to infinity.
Total radioactivity in plasma PK: CL/F
Time Frame: Up to 240 hours post dose.
Drug clearance.
Secondary Outcomes
- HLX208 and metabolite PK: t1/2(Up to 240 hours post dose.)
- Adverse events(Screening up to Day 15)
- HLX208 and metabolite PK: Cmax(Up to 240 hours post dose.)
- HLX208 and metabolite PK: AUC0-t(Up to 240 hours post dose.)
- HLX208 and metabolite PK: AUC0-∞(Up to 240 hours post dose.)
- HLX208 and metabolite PK: Tmax(Up to 240 hours post dose.)