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

Not Applicable

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: [14C]ICP-022

• Registration Number: NCT04441450
• Lead Sponsor: Beijing InnoCare Pharma Tech Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-07-01
• Primary Completion: 2019-08-06
• Study Completion: 2019-08-06
• Status Verified: 2020-06
• Study First Submitted: 2020-06-16
• Study First Submitted QC: 2020-06-18
• Last Update Submitted: 2020-06-18
• Study First Posted: 2020-06-22
• Last Update Posted: 2020-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 6

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

The First Affiliated Hospital of Soochow University; 🇨🇳 Suzhou, Jiangsu, China