Study of [14C]CS0159 in China Healthy Subjects

November 20, 2023 updated by: Cascade Pharmaceuticals, Inc

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
6

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Jiangsu
      • Suzhou, Jiangsu, China, 215006
        • The First Affiliated Hospital of Soochow University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: [14C]CS0159
Single oral dose of 4mg [14C]CS0159
Drug: [14C]CS0159
Single oral administration of 4mg [14C]CS0159

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Mass Balance
Time Frame: Screening period (-48 hours) to 240 hours
Mass balance recovery of total radioactivity in urine and fecal samples.
Screening period (-48 hours) to 240 hours
[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.
Screening period (-48 hours) to 240 hours
Radioactivity of CS0159
Time Frame: Up to 90 hours post dose
Whole blood to plasma total radioactivity ratio
Up to 90 hours post dose
Area under the curve
Time Frame: Up to 90 hours post dose
Total radioactivity in plasma PK: AUC
Up to 90 hours post dose
Highest radioactivity observed plasma concentration
Time Frame: Up to 90 hours post dose
Total radioactivity in plasma PK: Cmax
Up to 90 hours post dose
Time for Cmax
Time Frame: Up to 90 hours post dose
Total radioactivity in plasma PK: Tmax
Up to 90 hours post dose
Elimination half-life
Time Frame: Up to 90 hours post dose
Total radioactivity in plasma PK: T1/2
Up to 90 hours post dose

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Blood plasma PK
Time Frame: Up to 90 hours post dose
other major metabolites in plasma( if any).
Up to 90 hours post dose
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
Up to 240 hours post dose
AUC of CS0159
Time Frame: Up to 90 hours post dose
Area under the plasma concentration time curve of CS0159
Up to 90 hours post dose
Cmax of CS0159
Time Frame: Up to 90 hours post dose
Highest observed plasma concentration of CS0159
Up to 90 hours post dose
T1/2 of CS0159
Time Frame: Up to 90 hours post dose
Elimination half-life of CS0159
Up to 90 hours post dose
Tmax of CS0159
Time Frame: Up to 90 hours post dose
Time for Cmax of CS0159
Up to 90 hours post dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cascade Pharmaceuticals, Inc

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Deng Rong, Cascade Pharmaceuticals, Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 23, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 2, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 2, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 21, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 18, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 24, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 21, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 20, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CS0159-001B

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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