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Completed

NCT Number: NCT06098027

Study of [14C]CS0159 in China Healthy Subjects

Study of [14C]CS0159 in China Healthy Subjects.

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Key information

Conditions

Primary Biliary Cholangitis Bile Duct Diseases Biliary Tract Diseases Cholestasis Cholestasis, Intrahepatic Digestive System Diseases Fibrosis Liver Cirrhosis Liver Cirrhosis, Biliary Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215006, China

About this study

A phase I study to quantify the total mass balance in healthy subjects after a single dose of [14C]CS0159.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy male subjects between the ages of 18 and 45 years (inclusive).
  • Subjects should not weigh less than 50 kg, BMI between 19~26 kg/㎡.
  • No sperm donation or fertility plan during the study and within 12 months after the end of the study.
  • Understand the purpose and requirements of trial, subjects who have voluntarily participated in the study and signed the ICF, completion of tests as required.

Exclusion criteria

  • With abnormal and clinically significant comprehensive physical examinations, vital signs,laboratory examinations, 12-ECG, chest X-ray, and abdominal ultrasound.
  • 12-ECG QT(QTcF)>450ms.
  • The history of drug allergy.
  • Patients with malabsorption and gastrointestinal disorders or history of Vomiting, diarrhoea in the week prior to the screening period.
  • Patients with difficulty swallowing or interfere with drug absorption.
  • HBs Ag or E antigen, TPAb, or HIV-Ag/Ab positive person.
  • Have taken any clinical trial medication or participated in any other clinical trial within 3 months prior to the screening period.
  • Habitual constipation or diarrhoea.
  • Heavy smokers addicts
  • Heavy drinker addicts.
  • Has drug abuse history or positive drug abuse test results.
  • Heavy caffeine addicts.
  • Special dietary requirements.
  • Poor adherence or any other conditions judged by the investigator as not suitable for the study.

Treatment and study plan

[14C]CS0159

Drug

Single oral administration of 4mg [14C]CS0159

Primary outcomes

  1. Mass Balance

    Time frame: Screening period (-48 hours) to 240 hours

    Mass balance recovery of total radioactivity in urine and fecal samples.

  2. [14C] CS0159 metabolite

    Time frame: Screening period (-48 hours) to 240 hours

    Identification of the major metabolites of CS0159 in human plasma, urine and faeces, determine the main Determine the main biotransformation pathways and calculate the percentage of the administered dose of the prodrug and each metabolite in urine and faeces, and plasma prodrugs and circulating metabolites as a percentage of total exposure AUC.

  3. Radioactivity of CS0159

    Time frame: Up to 90 hours post dose

    Whole blood to plasma total radioactivity ratio

  4. Area under the curve

    Time frame: Up to 90 hours post dose

    Total radioactivity in plasma PK: AUC

  5. Highest radioactivity observed plasma concentration

    Time frame: Up to 90 hours post dose

    Total radioactivity in plasma PK: Cmax

  6. Time for Cmax

    Time frame: Up to 90 hours post dose

    Total radioactivity in plasma PK: Tmax

  7. Elimination half-life

    Time frame: Up to 90 hours post dose

    Total radioactivity in plasma PK: T1/2

Secondary outcomes

  1. Blood plasma PK

    Time frame: Up to 90 hours post dose

    other major metabolites in plasma( if any).

  2. Adverse events

    Time frame: Up to 240 hours post dose

    All subjects will be assessed for incidence and severity of adverse events (AEs) and serious AEs

  3. AUC of CS0159

    Time frame: Up to 90 hours post dose

    Area under the plasma concentration time curve of CS0159

  4. Cmax of CS0159

    Time frame: Up to 90 hours post dose

    Highest observed plasma concentration of CS0159

  5. T1/2 of CS0159

    Time frame: Up to 90 hours post dose

    Elimination half-life of CS0159

  6. Tmax of CS0159

    Time frame: Up to 90 hours post dose

    Time for Cmax of CS0159

Sponsors and collaborators

Lead sponsor

Cascade Pharmaceuticals, Inc

Other

Registry information

Official study title

[14C]CS0159 in Chinese Healthy Subjects for Mass Balance Phase I Study

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Oct 24, 2023
Registry last updated
Nov 21, 2023

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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