Status:
COMPLETED
ADME Study of [14C]ICP-022 in Healthy Males
Lead Sponsor:
Beijing InnoCare Pharma Tech Co., Ltd.
Conditions:
Healthy Volunteers
Eligibility:
MALE
18-45 years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- key Inclusion criteria:
- Weight: Body mass index (BMI) is 19\~26 kg/m2
- signing of informed consent
- Volunteers are able to communicate well with the investigators and be able to complete the trial according to the process
- Key Exclusion Criteria:
- 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.
- ophthalmologic examination shows abnormality and clinical significance
- Positive test for hepatitis B (surface antigens HBs), or C (antibody HCs), positive test for HIV, positive test for Syphilis antibody.
- 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) ;
- 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/Exclusion criteria may apply.
Exclusion
Key Trial Info
Start Date :
July 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 6 2019
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT04441450
Start Date
July 1 2019
End Date
August 6 2019
Last Update
June 22 2020
Active Locations (1)
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1
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China