Healthy Volunteers
Conditions
Brief summary
The purpose of this study is to investigate the absorption, the metabolic pathways and the excretion of ICP-022 in healthy male adult participants after administration of a single oral dose of 150 mg of 14C ICP-022.
Interventions
DRUG[14C]ICP-022
150mg suspension containing 100μCi of \[14C\]ICP-022
Sponsors
Beijing InnoCare Pharma Tech Co., Ltd.
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
key Inclusion criteria: 1. Weight: Body mass index (BMI) is 19\ 26 kg/m2 2. signing of informed consent 3. Volunteers are able to communicate well with the investigators and be able to complete the trial according to the process Key
Exclusion criteria
1. physical examination, vital signs, routine laboratory tests (blood routine, blood biochemistry, blood coagulation routine, urine routine, stool routine + occult blood, serum amylase, thyroid function, etc.), 12-lead ECG, Chest X-ray (Anteroposterior), abdominal B-ultrasound (hepatobiliary, pancreas, spleen and kidney) and other abnormalities and clinical significance. 2. ophthalmologic examination shows abnormality and clinical significance 3. Positive test for hepatitis B (surface antigens HBs), or C (antibody HCs), positive test for HIV, positive test for Syphilis antibody. 4. Within 1 month before the screening, having not limited to known as hepatic enzyme inducers, inhibitors or substrates; (eg, inducer - barbiturate, carbamazepine, phenytoin, rifampicin, dexamethasone, rifabutin, rifapentine; inhibitors - SSRI antidepressants, cimetidine, diltiazem, macrolides, verapamil, imidazole antifungals) ; 5. Within 1 month before the screening, receiving the anticoagulant therapy such as warfarin or thrombin inhibitor and/or aspirin antiplatelet therapy NOTE: Other protocol defined Inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Distribution ratio of total radioactivity in whole blood and plasma of [14C]ICP-022 | Up to14 days | To investigate the pharmacokinetics of total radioactivity in plasma after oral \[14C\] ICP-022 in healthy volunteers, and the distribution ratio of total radioactivity in whole blood and plasma. |
| Quantitative analysis of total radioactivity in excreta after oral [14C] ICP-022 in healthy volunteers | Up to14 days | Quantitative analysis of total radioactivity in excreta after oral \[14C\] ICP-022 in healthy volunteers, obtaining body material balance data and main excretion pathways |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quantitative analysis of the concentration of ICP-022 in plasma | Up to14 days | Quantitative analysis of the concentration of ICP-022 in plasma to obtain the pharmacokinetic parameters of ICP-022 |
| The biotransformation pathways of [14C]ICP-022 | Up to14 days | Urine and fecal collection for metabolite profiling. Identify the main metabolites in humans after oral \[14\]ICP-022 in healthy volunteers to determine the main biotransformation pathways. |
Countries
China
Outcome results
None listed