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

Healthy Volunteers Clinical Trial

Official title:

Absorption, Metabolism, and Excretion of Oral 14C Radiolabeled ICP-022: An Open-Label, Phase I, Single-Dose Study in Healthy Males

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04441450
• Other study ID #: ICP-CL-00110
• Status: Completed
• Phase: N/A
• Start date: July 1, 2019
• Est. completion date: August 6, 2019

Study information

• Verified date: June 2020
• Source: Beijing InnoCare Pharma Tech Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: August 6, 2019
• Est. primary completion date: August 6, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• [14C]ICP-022
150mg suspension containing 100µCi of [14C]ICP-022

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Soochow University	Suzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Beijing InnoCare Pharma Tech Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Quantitative analysis of the concentration of ICP-022 in plasma	Quantitative analysis of the concentration of ICP-022 in plasma to obtain the pharmacokinetic parameters of ICP-022	Up to14 days
Secondary	The biotransformation pathways of [14C]ICP-022	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.	Up to14 days