A Mass Balance Study of [14C]IBI351 in Healthy Male Chinese Subjects
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 6
- Locations
- 1
- Primary Endpoint
- cumulative recovery of total radioactivity in excreta (urine and feces)
Study Overview
Brief Summary
This study is to evaluate the mass balance of single oral dose of [14C] IBI351 in healthy subjects. Six to eight healthy male subjects were planned to be enrolled. After passing the screening, subjects were admitted to hospital and received training on medication, urine and feces collection and other procedures to ensure that they could perform relevant operations according to the protocol and SOP requirements. On the evening before medication, the patient had standard meals, and fasted uniformly overnight. On D1, the suspension containing recommended dose of [14C] IBI351 was administered in the morning on an empty stomach. Subjects have standardized meal during the trial and blood, urine, and feces samples were collected and safety laboratory tests were performed as scheduled.
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
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
[14C] IBI351
Recommended dose of [14C] IBI351
Intervention: [14C] IBI351 (Drug)
Outcomes
Primary Outcomes
cumulative recovery of total radioactivity in excreta (urine and feces)
Time Frame: approximately 30 days after first dose
percentage of metabolite in total exposure AUC in plasma (% AUC)
Time Frame: approximately 30 days after first dose
Percentage of each metabolite in feces to administered dose (% of administered dose)
Time Frame: approximately 30 days after first dose
total radioactivity ratio for whole blood/plasma
Time Frame: approximately 30 days after first dose
maximum concentrations (Cmax ) for total plasma radioactivity
Time Frame: approximately 30 days after first dose
time-to-maximum concentration (Tmax) for total plasma radioactivity
Time Frame: approximately 30 days after first dose
area under the curve from time 0 to the last time point (AUC0-t) for total plasma radioactivityarea under the curve from time 0 to the last time point (AUC0-t) for total plasma radioactivity
Time Frame: approximately 30 days after first dose
apparent clearance (CL/F) for total plasma radioactivity
Time Frame: approximately 30 days after first dose
apparent volume of distribution(Vz/F) for total plasma radioactivity
Time Frame: approximately 30 days after first dose
percentage of each metabolite in urine to administered dose (% of administered dose)
Time Frame: approximately 30 days after first dose
half-life (t1/2) for total plasma radioactivity
Time Frame: approximately 30 days after first dose
area under the curve from time 0 to infinity(AUC0-inf) for total plasma radioactivity
Time Frame: approximately 30 days after first dose
Secondary Outcomes
- abnormality in ECG parameters(approximately 30 days after first dose)
- time-to-maximum concentration (Tmax) for plasma(approximately 30 days after first dose)
- apparent clearance (CL/F) for plasma(approximately 30 days after first dose)
- abnormality in clinical chemistry parameters(approximately 30 days after first dose)
- maximum concentrations (Cmax ) for plasma(approximately 30 days after first dose)
- area under the curve from time 0 to infinity(AUC0-inf) for plasma(approximately 30 days after first dose)
- abnormality in routine stool parameters(approximately 30 days after first dose)
- area under the curve from time 0 to the last time point (AUC0-t) for plasma(approximately 30 days after first dose)
- adverse events(approximately 30 days after first dose)
- apparent volume of distribution(Vz/F) for plasma(approximately 30 days after first dose)
- abnormality in vital signs(approximately 30 days after first dose)
- abnormality in physical examination(approximately 30 days after first dose)
- abnormality in hematology parameters(approximately 30 days after first dose)
- abnormality in routine urinalysis parameters(approximately 30 days after first dose)
- abnormality in Troponin T (TnT)(approximately 30 days after first dose)
- abnormality in coagulation parameters(approximately 30 days after first dose)