Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06098027
Other study ID # CS0159-001B
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date October 23, 2023
Est. completion date November 2, 2023

Study information

Verified date October 2023
Source Cascade Pharmaceuticals, Inc
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

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


Recruitment information / eligibility

Status Completed
Enrollment 6
Est. completion date November 2, 2023
Est. primary completion date November 2, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria: 1. Healthy male subjects between the ages of 18 and 45 years (inclusive). 2. Subjects should not weigh less than 50 kg, BMI between 19~26 kg/?. 3. No sperm donation or fertility plan during the study and within 12 months after the end of the study. 4. 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: 1. With abnormal and clinically significant comprehensive physical examinations, vital signs,laboratory examinations, 12-ECG, chest X-ray, and abdominal ultrasound. 2. 12-ECG QT(QTcF)>450ms. 3. The history of drug allergy. 4. Patients with malabsorption and gastrointestinal disorders or history of Vomiting, diarrhoea in the week prior to the screening period. 5. Patients with difficulty swallowing or interfere with drug absorption. 6. HBs Ag or E antigen, TPAb, or HIV-Ag/Ab positive person. 7. Have taken any clinical trial medication or participated in any other clinical trial within 3 months prior to the screening period. 8. Habitual constipation or diarrhoea. 9. Heavy smokers addicts 10. Heavy drinker addicts. 11. Has drug abuse history or positive drug abuse test results. 12. Heavy caffeine addicts. 13. Special dietary requirements. 14. Poor adherence or any other conditions judged by the investigator as not suitable for the study.

Study Design


Intervention

Drug:
[14C]CS0159
Single oral administration of 4mg [14C]CS0159

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Cascade Pharmaceuticals, Inc

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mass Balance Mass balance recovery of total radioactivity in urine and fecal samples. Screening period (-48 hours) to 240 hours
Primary [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
Primary Radioactivity of CS0159 Whole blood to plasma total radioactivity ratio Up to 90 hours post dose
Primary Area under the curve Total radioactivity in plasma PK: AUC Up to 90 hours post dose
Primary Highest radioactivity observed plasma concentration Total radioactivity in plasma PK: Cmax Up to 90 hours post dose
Primary Time for Cmax Total radioactivity in plasma PK: Tmax Up to 90 hours post dose
Primary Elimination half-life Total radioactivity in plasma PK: T1/2 Up to 90 hours post dose
Secondary Blood plasma PK other major metabolites in plasma( if any). Up to 90 hours post dose
Secondary Adverse events All subjects will be assessed for incidence and severity of adverse events (AEs) and serious AEs Up to 240 hours post dose
Secondary AUC of CS0159 Area under the plasma concentration time curve of CS0159 Up to 90 hours post dose
Secondary Cmax of CS0159 Highest observed plasma concentration of CS0159 Up to 90 hours post dose
Secondary T1/2 of CS0159 Elimination half-life of CS0159 Up to 90 hours post dose
Secondary Tmax of CS0159 Time for Cmax of CS0159 Up to 90 hours post dose
See also
  Status Clinical Trial Phase
Completed NCT02516605 - A Multi-part, Double Blind Study to Assess Safety, Tolerability and Efficacy of Tropifexor (LJN452) in PBC Patients Phase 2
Recruiting NCT06051617 - Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis Phase 3
Recruiting NCT06060665 - IDEAL: Intended to Determine the Effects of Seladelpar on Normalization of Alkaline Phosphatase Levels in Subjects With Primary Biliary Cholangitis (PBC) and an Incomplete Response or Intolerance to Ursodeoxycholic Acid (UDCA) Phase 3
Recruiting NCT05450887 - Efficacy and Safety of Obeticholic Acid in the Treatment of Primary Biliary Cholangitis Phase 3
Recruiting NCT05050136 - A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Biliary Cholangitis Phase 2
Recruiting NCT05151809 - National Database on Primary Biliary Cholangitis
Recruiting NCT04076527 - Prospective, Multicenter Cohort Study on Primary Biliary Cholangitis
Recruiting NCT04950764 - An Open-Label Study Following Oral Dosing of Seladelpar to Subjects With Primary Biliary Cholangitis (PBC) and Hepatic Impairment (HI) Phase 1
Completed NCT03545672 - Early Identification of Myocardial Impairment in PBC
Active, not recruiting NCT04594694 - Study of OCA in Combination With BZF Evaluating Efficacy, Safety, and Tolerability in Participants With PBC Phase 2
Completed NCT03602560 - ENHANCE: Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or an Intolerance to Ursodeoxycholic Acid (UDCA) Phase 3
Suspended NCT03684187 - Mindfulness - Based Intervention in the Treatment of Fatigue in Patients With Primary Biliary Cholangitis N/A
Recruiting NCT04617561 - Ursodeoxycholic Acid Combined With Low Dose Glucocorticoid in the Treatment of PBC With AIH Features II Phase 4
Terminated NCT03092765 - Study of E6011 in Japanese Subjects With Primary Biliary Cholangitis Inadequately Responding to Ursodeoxycholic Acid Phase 2
Completed NCT04604652 - Open-Label Study of HTD1801 in Adult Subjects With Primary Biliary Cholangitis Phase 2
Not yet recruiting NCT06417398 - Preliminary Clinical Study of UTAA09 Injection in the Treatment of Relapsed/Refractory Autoimmune Diseases Early Phase 1
Recruiting NCT05919433 - Detection Program for Patients With Primary Biliary Cholangitis Lost in the System
Completed NCT06309589 - The Effectiveness of Combining Ursodeoxycholic Acid With Vitamin D in Treating Patients With Primary Biliary Cholangitis N/A
Completed NCT05292872 - Real-World Data Study to Evaluate the Effectiveness of OCA on Hepatic Outcomes in PBC Patients
Withdrawn NCT05293938 - A Real-World Data Study to Evaluate the Effectiveness of OCA on Hepatic Outcomes in PBC Patients