Study of [14C]CS0159 in China Healthy Subjects

NCT06098027 | Completed Phase 1

• 1 other identifier: CS0159-001B
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Primary Biliary Cholangitis

Outcome Measures

Primary Outcomes (7)

• Mass Balance

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

  Screening period (-48 hours) to 240 hours

• [14C] CS0159 metabolite

  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.

  Screening period (-48 hours) to 240 hours

• Radioactivity of CS0159

  Whole blood to plasma total radioactivity ratio

  Up to 90 hours post dose

• Area under the curve

  Total radioactivity in plasma PK: AUC

  Up to 90 hours post dose

• Highest radioactivity observed plasma concentration

  Total radioactivity in plasma PK: Cmax

  Up to 90 hours post dose

• Time for Cmax

  Total radioactivity in plasma PK: Tmax

  Up to 90 hours post dose

• Elimination half-life

  Total radioactivity in plasma PK: T1/2

  Up to 90 hours post dose

Secondary Outcomes (6)

• Blood plasma PK

  Up to 90 hours post dose

• Adverse events

  Up to 240 hours post dose

• AUC of CS0159

  Up to 90 hours post dose

• Cmax of CS0159

  Up to 90 hours post dose

• T1/2 of CS0159

  Up to 90 hours post dose

Study Arms (1)

[14C]CS0159

EXPERIMENTAL

Single oral dose of 4mg \[14C\]CS0159

Drug: [14C]CS0159

Interventions

[14C]CS0159 DRUG

Single oral administration of 4mg \[14C\]CS0159

[14C]CS0159

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• With abnormal and clinically significant comprehensive physical examinations, vital signs,laboratory examinations, 12-ECG, chest X-ray, and abdominal ultrasound.
• 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.

Sponsors & Collaborators

• Cascade Pharmaceuticals, Inc: lead

Study Sites (1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215006, China

Location

MeSH Terms

Conditions

Liver Cirrhosis, Biliary

Condition Hierarchy (Ancestors)

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

Study Officials

• Deng Rong

  Cascade Pharmaceuticals, Inc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2023
• First Posted: October 24, 2023
• Study Start: October 23, 2023
• Primary Completion: November 2, 2023
• Study Completion: November 2, 2023
• Last Updated: November 21, 2023

Record last verified: 2023-10

Locations

CN (1)