ADME Study of [14C]ICP-022 in Healthy Males

InnoCare Pharma

Status: Completed

Conditions: Healthy Volunteers

Treatments: Drug: [14C]ICP-022

Study type: Interventional

Funder types: Industry

Identifiers

NCT04441450

ICP-CL-00110

Details and patient eligibility

About

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.

Enrollment: 6 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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/Exclusion criteria may apply.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

[14C]ICP-022

Experimental group

Description:

Subjects will take a single of 150mg 100μCi of \[14C\]ICP-022.

Treatment:

Drug: [14C]ICP-022