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

• Sponsor: Beijing InnoCare Pharma Tech Co., Ltd. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04441450
• Collaborator: (none)
• Enrollment: 6
• Location: 1
• Arm: 1
• Actual Duration (Months): 1.2
• Patients Per Site Per Month: 5.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Drug: [14C]ICP-022	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 6 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Absorption, Metabolism, and Excretion of Oral 14C Radiolabeled ICP-022: An Open-Label, Phase I, Single-Dose Study in Healthy Males
• Actual Study Start Date: Jul 1, 2019
• Actual Primary Completion Date: Aug 6, 2019
• Actual Study Completion Date: Aug 6, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: [14C]ICP-022 Subjects will take a single of 150mg 100μCi of [14C]ICP-022.	Drug: [14C]ICP-022; 150mg suspension containing 100μCi of [14C]ICP-022

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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

1. 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

2. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The First Affiliated Hospital of Soochow University	Suzhou	Jiangsu	China

Sponsors and Collaborators

• Beijing InnoCare Pharma Tech Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Beijing InnoCare Pharma Tech Co., Ltd.
• ClinicalTrials.gov Identifier: NCT04441450
• Other Study ID Numbers: ICP-CL-00110
• First Posted: Jun 22, 2020
• Last Update Posted: Jun 22, 2020
• Last Verified: Jun 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Jun 22, 2020