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

NCT04441450 | Completed

• 1 other identifier: ICP-CL-00110
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (2)

• Distribution ratio of total radioactivity in whole blood and plasma of [14C]ICP-022

  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.

  Up to14 days

• Quantitative analysis of total radioactivity in excreta after oral [14C] ICP-022 in healthy volunteers

  Quantitative analysis of total radioactivity in excreta after oral \[14C\] ICP-022 in healthy volunteers, obtaining body material balance data and main excretion pathways

  Up to14 days

Secondary Outcomes (2)

• Quantitative analysis of the concentration of ICP-022 in plasma

  Up to14 days

• The biotransformation pathways of [14C]ICP-022

  Up to14 days

Study Arms (1)

[14C]ICP-022

EXPERIMENTAL

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

Drug: [14C]ICP-022

Interventions

[14C]ICP-022 DRUG

150mg suspension containing 100μCi of \[14C\]ICP-022

[14C]ICP-022

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing InnoCare Pharma Tech Co., Ltd.: lead

Study Sites (1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2020
• First Posted: June 22, 2020
• Study Start: July 1, 2019
• Primary Completion: August 6, 2019
• Study Completion: August 6, 2019
• Last Updated: June 22, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)