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Completed

NCT Number: NCT04441450

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

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.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

key Inclusion criteria:

  • 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

Key Exclusion Criteria:

  • 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

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Treatment and study plan

[14C]ICP-022

Drug

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

Primary outcomes

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

    Time frame: 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

    Time frame: 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 outcomes

  1. Quantitative analysis of the concentration of ICP-022 in plasma

    Time frame: 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Beijing InnoCare Pharma Tech Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jun 22, 2020
Registry last updated
Jun 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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