Primary Biliary CholangitisPhase 1NCT06098027
Study of [14C]CS0159 in China Healthy Subjects
A Phase 1 study testing [14C]CS0159 in people with Primary Biliary Cholangitis, run by Cascade Pharmaceuticals, Inc at 1 site in China.
Trial summary
Study of [14C]CS0159 in China Healthy Subjects. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Primary Biliary Cholangitis
- What is being tested?
- [14C]CS0159
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteChina
- Study dates
- 23 Oct 2023to 2 Nov 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006
About this study
Official title: [14C]CS0159 in Chinese Healthy Subjects for Mass Balance Phase I Study
Study of [14C]CS0159 in China Healthy Subjects.
Read the detailed description
A phase I study to quantify the total mass balance in healthy subjects after a single dose of [14C]CS0159.
- Conditions
- Primary Biliary Cholangitis
- Being tested
- [14C]CS0159
- Medical subject headings
- Liver Cirrhosis, Biliary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[14C]CS0159Drug
Single oral administration of 4mg [14C]CS0159
| Study group | Role | What they receive |
|---|---|---|
| [14C]CS0159 | Experimental | Single oral dose of 4mg [14C]CS0159 Receives: Drug: [14C]CS0159 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mass Balance
Mass balance recovery of total radioactivity in urine and fecal samples.
Measured: 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.
Measured: Screening period (-48 hours) to 240 hours
Radioactivity of CS0159
Whole blood to plasma total radioactivity ratio
Measured: Up to 90 hours post dose
Area under the curve
Total radioactivity in plasma PK: AUC
Measured: Up to 90 hours post dose
Highest radioactivity observed plasma concentration
Total radioactivity in plasma PK: Cmax
Measured: Up to 90 hours post dose
Time for Cmax
Total radioactivity in plasma PK: Tmax
Measured: Up to 90 hours post dose
Elimination half-life
Total radioactivity in plasma PK: T1/2
Measured: Up to 90 hours post dose
Secondary outcomes (6)
Blood plasma PK
other major metabolites in plasma( if any).
Measured: Up to 90 hours post dose
Adverse events
All subjects will be assessed for incidence and severity of adverse events (AEs) and serious AEs
Measured: Up to 240 hours post dose
AUC of CS0159
Area under the plasma concentration time curve of CS0159
Measured: Up to 90 hours post dose
Cmax of CS0159
Highest observed plasma concentration of CS0159
Measured: Up to 90 hours post dose
T1/2 of CS0159
Elimination half-life of CS0159
Measured: Up to 90 hours post dose
Tmax of CS0159
Time for Cmax of CS0159
Measured: Up to 90 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2023
- Study start23 Oct 2023
- Primary completion2 Nov 2023
- Study completion2 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Biliary CholangitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cascade Pharmaceuticals, Inc
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Deng Rong, Study director, Cascade Pharmaceuticals, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06098027
- Sponsor's protocol ID
- CS0159-001B
- Status last verified
- Oct 2023
- First submitted
- 21 Sep 2023
- Last updated
- 21 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- [14C]CS0159 in Chinese Healthy Subjects for Mass Balance Phase I Study
- ClinicalTrials.gov ID
- NCT06098027
- Acronym / sponsor ID
- CS0159-001B
- Conditions
- Primary Biliary Cholangitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Cascade Pharmaceuticals, IncUniversity, hospital or other
- Study start
- 23 Oct 2023 (actual)
- Primary completion
- 2 Nov 2023 (actual)
- Study completion
- 2 Nov 2023 (actual)
- First posted
- 24 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study of [14C]CS0159 in China Healthy Subjects.
Detailed description
A phase I study to quantify the total mass balance in healthy subjects after a single dose of [14C]CS0159.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [14C]CS0159 | Experimental | Drug: [14C]CS0159Single oral dose of 4mg [14C]CS0159 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [14C]CS0159Single oral administration of 4mg [14C]CS0159 | Drug | [14C]CS0159 |
Primary outcome
Mass Balance
Time frame: Screening period (-48 hours) to 240 hours
Mass balance recovery of total radioactivity in urine and fecal samples.
[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.
Radioactivity of CS0159
Time frame: Up to 90 hours post dose
Whole blood to plasma total radioactivity ratio
Area under the curve
Time frame: Up to 90 hours post dose
Total radioactivity in plasma PK: AUC
Highest radioactivity observed plasma concentration
Time frame: Up to 90 hours post dose
Total radioactivity in plasma PK: Cmax
Time for Cmax
Time frame: Up to 90 hours post dose
Total radioactivity in plasma PK: Tmax
Elimination half-life
Time frame: Up to 90 hours post dose
Total radioactivity in plasma PK: T1/2
6 secondary outcomes
Blood plasma PK
Time frame: Up to 90 hours post dose
Adverse events
Time frame: Up to 240 hours post dose
AUC of CS0159
Time frame: Up to 90 hours post dose
Cmax of CS0159
Time frame: Up to 90 hours post dose
T1/2 of CS0159
Time frame: Up to 90 hours post dose
Tmax of CS0159
Time frame: Up to 90 hours post dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2023.
Related trials for Primary Biliary Cholangitis
RecruitingPhase 3
A Long-Term Study of Elafibranor in Adult Participants With Primary Biliary Cholangitis
Primary Biliary Cholangitis (PBC)
Active, not recruitingObservational study
A Study Observing Everyday Effectiveness and Safety of the Drug Elafibranor in Participants With Primary Biliary Cholangitis Who Are Receiving Ongoing Treatment
Primary Biliary Cholangitis
Active, not recruitingPhase 3
A Study of Elafibranor in Adult Japanese Participants With Primary Biliary Cholangitis (PBC)
Primary Biliary Cholangitis
RecruitingPhase 3
Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis
Primary Biliary Cholangitis
Not yet recruitingPhase 2
Nemolizumab for the Treatment of Moderate to Severe Chronic Hepatic Pruritus
Chronic Hepatic Pruritus, Cholestatic Liver Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deng Rong study director
Cascade Pharmaceuticals, Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing [14C]CS0159 in people with Primary Biliary Cholangitis, run by Cascade Pharmaceuticals, Inc at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mass Balance (time frame: Screening period (-48 hours) to 240 hours). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2023; AzTrials last refreshed its copy on 26 Oct 2026.