Healthy VolunteersPhase 1NCT07429331

Drug Interaction and Food Effect Study of CS0159

A Phase 1 study testing CS0159 Tablet, Rifampicin Capsule and Itraconazole Capsule in people with Healthy Volunteers, run by Cascade Pharmaceuticals, Inc at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Purpose: This study aims to evaluate the effect of food (high-fat, high-calorie meal) on the pharmacokinetic (PK) profile of CS0159 tablets and to assess the drug-drug interactions (DDI) when CS0159 is co-administered with a strong CYP3A4 inducer (rifampicin) and a strong CYP3A4 inhibitor (itraconazole), respectively. Read more about this study

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers
What is being tested?: CS0159 Tablet, Rifampicin Capsule and Itraconazole Capsule
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 32 participants
Where: 1 siteChina
Study dates: 9 Mar 2026to 1 Apr 2026
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
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy male or female participants aged between 18 and 45 years (inclusive);
Male weight ≥ 50.0 kg, female weight ≥ 45.0 kg; body mass index (BMI) within the range of 19.0 to 26.0 kg/m² (including the threshold values);
Normal renal function (glomerular filtration rate calculated using the CKD-EPI equation ≥ 90 mL/min/1.73 m²);
Participants (including male participants) agree to have no plans for conception from screening until 3 months after the last dose, voluntarily adopt effective contraceptive measures, and have no plans for sperm or egg donation;
Participants fully understand the study purpose, nature, procedures, and potential adverse events, voluntarily agree to participate as subjects, can communicate well with the investigator, comply with all study requirements, and sign the informed consent form before the initiation of any study procedures.

Who cannot join

History of allergic diseases (e.g., asthma, urticaria, eczema, etc.), allergic constitution (e.g., allergy to two or more drugs), or known hypersensitivity to CS0159, rifampicin, itraconazole, or any excipients;
Participants with clinically significant findings, as judged by the investigator, of the following diseases (including but not limited to gastrointestinal, renal, hepatic, neurological, hematological, endocrine, oncological, pulmonary, immunological, psychiatric, or cardiovascular/cerebrovascular diseases) that may complicate protocol implementation or interpretation of study results, or whom the investigator considers to be at risk from participating in the study;
History of susceptibility to pruritus, or presence of conditions such as eczema/atopic dermatitis, neurodermatitis, psoriasis, or other diseases that may cause pruritus;
History of corrected QT interval (QTc) prolongation at screening:
QTc interval prolongation on 12-lead electrocardiogram (ECG) (QTcF ≥450 ms in males; QTcF ≥470 ms in females);
Family history of hypocalcemia or long QT syndrome.

Show all 28Show fewer

History of acute or chronic bronchospasm (including treated or untreated asthma, chronic obstructive pulmonary disease);
Occurrence of an acute illness within 2 weeks prior to the first dose;
Presence of any known disease or condition that may interfere with drug absorption, distribution, metabolism, or excretion, including bile salt metabolism in the large intestine. Examples include inflammatory bowel disease, gastrectomy, cholecystectomy, etc.;
Use of drugs affecting hepatic metabolic enzyme function (e.g., barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole, SSRIs, cimetidine, diltiazem, macrolides, nitroimidazoles, sedative-hypnotics, verapamil, fluoroquinolones, antihistamines) within 30 days prior to the first dose, or requirement for concomitant use of other drugs that may affect the absorption, distribution, metabolism, or excretion of the investigational drug during the study period;
History of blood donation within 3 months prior to the first dose, total blood loss ≥400 mL due to donation or other reasons within 6 months, or plans to donate blood during the study or within 3 months after study completion;
Current smokers, or participants unwilling to discontinue nicotine product use from 3 months before screening and during the study, or with positive urine cotinine test results;
Excessive consumption of tea, coffee, or caffeinated beverages (more than 8 cups per day, 1 cup = 250 mL) within 6 months prior to screening; or consumption of any food or beverage rich in caffeine and/or xanthine (e.g., coffee, strong tea, chocolate, caffeinated carbonated beverages, cola, etc.) from 48 hours before the first dose until the end of the study; or unwillingness to abstain from alcohol, fruit juice beverages, strenuous exercise, or other factors that may affect drug absorption, distribution, metabolism, or excretion;
Average weekly alcohol consumption exceeding 14 units (1 unit = 360 mL beer, 45 mL of 40% alcohol liquor, or 150 mL wine) in the past year, or inability to abstain from alcohol during the study, or alcohol breath test result >0.0 mg/100 mL;
Drug abusers or participants with positive results on drug abuse screening (morphine, tetrahydrocannabinol acid, methamphetamine, methylenedioxymethamphetamine, ketamine, and cocaine);
Participation in another drug clinical trial within 3 months prior to this study (Note: The end date is defined as the date of discontinuation from the most recent clinical trial involving drugs or devices);
Positive screening results for hepatitis C virus antibody, hepatitis B surface antigen, HIV antibody, or syphilis treponemal antibody; abnormal liver function: AST, ALT, ALP, GGT, and TBil > upper limit of normal (ULN);
Abnormal and clinically significant findings on physical examination, vital signs, laboratory tests, 12-lead ECG, or abdominal ultrasound at screening, as judged by the investigator;
Use of prescription or over-the-counter medications within 14 days prior to the first dose or within at least 5 half-lives (whichever is longer);
Use of any drugs or substances (e.g., herbal medicines, grapefruit, etc.) that may affect CYP3A activity within 14 days before taking the study drug and during the study period;
Difficulty swallowing, intolerance to venipuncture/indwelling needles, difficulty with blood sampling, history of needle or blood phobia, special dietary requirements, or inability to comply with standardized meals;
Any other conditions deemed unsuitable for participation by the investigator.
Additional exclusion criteria for female participants:
Use of oral contraceptives within 30 days prior to screening until randomization;
Use of long-acting estrogen or progestin injections (including progestin-containing intrauterine devices) or implants within 6 months prior to screening until randomization;
Unprotected sexual intercourse with a partner within 14 days prior to screening until randomization;
Positive pregnancy test;
Pregnant or breastfeeding females.

Trial locations and contacts

1 site in 1 country.

China1 site

Shanghai Xuhui Central Hospital
Shanghai, Shanghai Municipality

Other trials in China

About this study

Official title: Evaluation of Drug-Drug Interactions Between CS0159 Tablets and Rifampicin/Itraconazole and the Effect of a High-Fat Meal on the Pharmacokinetic Characteristics of CS0159 Tablets in Healthy Adult Participants

Design:

Part A (DDI - Induction): Single-center, open-label, fixed-sequence design. Sixteen healthy participants will receive a single dose of CS0159 (4 mg) under fasting conditions on Day 1, rifampicin alone (600 mg, QD) under fasting conditions on Days 2-8, and co-administration of CS0159 with rifampicin under fasting conditions on Day 9.

Part B (Food Effect \& DDI - Inhibition): Single-center, open-label, two-phase design. Sixteen healthy participants will first undergo a randomized, two-period, two-sequence crossover food effect study (CS0159 4 mg administered under fasting vs. high-fat meal conditions). All participants will then enter the second phase, receiving itraconazole (200 mg, QD) after a meal for 5 consecutive days, followed by co-administration of CS0159 with itraconazole after a high-fat meal on the 6th day.

Endpoints: The primary endpoints are the pharmacokinetic parameters of CS0159 (C~max, AUC~0-t, AUC~0-∞)and other PK parameters (Tmax，t1/2，λz，AUC_%Extrap，Tlag，CL/F，V/F). Secondary endpoints include safety (adverse events, vital signs, laboratory tests, etc.) .

Read the detailed description

Study Background: CS0159 is a novel farnesoid X receptor agonist under development for the treatment of diseases such as nonalcoholic steatohepatitis, primary biliary cholangitis, and primary sclerosing cholangitis. Preclinical studies indicate that CS0159 is primarily metabolized by the CYP3A4 enzyme. According to relevant guidelines, it is necessary to evaluate the impact of CYP3A4 modulators (rifampicin and itraconazole) on the exposure of CS0159, as well as the effect of food on its pharmacokinetics, to guide safe clinical use.
Study Design and Methods: Overall Design: The study consists of two independent parts (Part A and Part B), planning to enroll a total of 32 healthy adult participants (both sexes) aged 18-45. Part A - DDI Study with Rifampicin: A fixed-sequence design is employed. Participants, under fasting conditions, sequentially receive CS0159 monotherapy, rifampicin monotherapy (for 7 consecutive days), and then co-administration of both drugs. Intensive blood sampling is performed for PK analysis. Part B - Food Effect and DDI Study with Itraconazole: Phase 1 (Food Effect): A randomized, open-label, two-period, two-sequence crossover design is used. Participants are randomly divided into two groups to receive a single dose of CS0159 under fasting and high-fat meal conditions, respectively, with a 2-day washout period between the two periods. Phase 2 (DDI Study with Itraconazole): All participants who complete Phase 1 enter this phase. Participants first receive itraconazole after a meal for 5 consecutive days, followed by co-administration of CS0159 with itraconazole after a high-fat meal. Pharmacokinetic and Safety Assessments: Blood samples are collected at scheduled time points during all CS0159 dosing periods (monotherapy or co-administration). CS0159 plasma concentrations are determined using a validated LC-MS/MS method. Throughout the study, adverse events, vital signs, physical examinations, 12-lead ECGs, and laboratory test results are continuously monitored and recorded.
Statistical Methods:

Pharmacokinetic parameters will be calculated using non-compartmental analysis. For DDI analysis, analysis of variance will be performed on log-transformed C~max~ and AUC values, and geometric mean ratios with their 90% confidence intervals will be calculated. Food effect analysis will employ a crossover design analysis of variance. Safety data will be summarized using descriptive statistics.

Conditions: Healthy Volunteers
Being tested: CS0159 Tablet, Rifampicin Capsule, Itraconazole Capsule

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CS0159 TabletDrug
Also called Investigational drug (FXR agonist)
A novel, selective farnesoid X receptor (FXR) agonist.
Rifampicin CapsuleDrug
Also called CYP3A4 inducer (perpetrator drug)
A strong cytochrome P450 3A4 (CYP3A4) enzyme inducer.
Itraconazole CapsuleDrug
Also called CYP3A4 inhibitor (perpetrator drug)
A strong cytochrome P450 3A4 (CYP3A4) enzyme inhibitor.

Study groups in NCT07429331
Study group	Role	What they receive
Part A: CS0159 + Rifampicin (DDI)	Experimental	Healthy participants receive a single oral dose of CS0159 (4 mg) under fasting conditions on Day 1, followed by oral rifampicin (600 mg) once daily under fasting conditions on Days 2-8, and then co-administration of both drugs under fasting conditions on Day 9. Receives: Drug: CS0159 Tablet; Drug: Rifampicin Capsule
Part B: CS0159 (Food Effect)	Experimental	The 16 enrolled participants are randomly assigned to two groups (fasting-fed group and fed-fasting group) in Phase 1, with an equal number in each group. Each group receives a single 4 mg dose per period, with a 2-day washout period (in-house). Receives: Drug: CS0159 Tablet
Part B: CS0159 + Itraconazole (DDI)	Experimental	Healthy participants receive oral itraconazole capsules (200 mg, two capsules of 0.1 g each) once daily in the morning under fed conditions (following a standard meal) from Day 4 to Day 8 (D4~D8), which corresponds to days 2 to 6 after completing the second period of Phase 1. This constitutes 5 consecutive days of itraconazole administration. On the 6th administration day (D9), participants simultaneously take itraconazole capsules (200 mg) and CS0159 tablets (4 mg, two tablets of 2 mg each) under fed conditions (following a high-fat meal). Receives: Drug: CS0159 Tablet; Drug: Itraconazole Capsule

What is being measured

The primary outcome is the main question the study is designed to answer.

Cmax of CS0159
Maximum observed plasma concentration (Cmax) of CS0159
Measured: Day 1, Day 3, Day 9
AUC0-t of CS0159
Area under the plasma concentration-time curve from time zero to the last measurable concentration (AUC0-t) of CS0159
Measured: Day 1, Day 3, Day 9
AUC0-∞ of CS0159
Area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC0-∞) of CS0159
Measured: Day 1, Day 3, Day 9
Tmax of CS0159
Time to reach Cmax (Tmax)
Measured: Day 1, Day 3, Day 9
t1/2 of CS0159
terminal elimination half-life (t1/2)
Measured: Day 1, Day 3, Day 9
CL/F of CS0159
apparent oral clearance (CL/F)
Measured: Day 1, Day 3, Day 9

Secondary outcomes (1)

Incidence of Treatment-Emergent Adverse Events (TEAEs)
Observe all adverse medical events occurring in participants during the clinical study period, including clinical symptoms and clinically significant abnormalities in vital signs, physical examinations, laboratory tests, and electrocardiograms. Record their clinical manifestations, severity, time of onset, time of resolution, duration, management measures, outcomes, and assess their relationship to the investigational product.
Measured: From screening until 7 days after the last dose.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 Mar 20261 Apr 2026

First posted24 Feb 2026
Study start9 Mar 2026
Primary completion25 Mar 2026
Study completion1 Apr 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Healthy VolunteersStudies 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: Basic science
Allocation: Randomised
Intervention model: Crossover
Model description: This is a two-part, hybrid-design pharmacokinetic study: 1. Part A (n=16): A single-group, fixed-sequence study. All participants receive CS0159 monotherapy (Day 1), followed by rifampicin alone (Days 2-8), and then co-administration of both drugs (Day 9) to assess the inducing effect of rifampicin on CS0159. 2. Part B (n=16): This part consists of two sequential phases within the same cohort: * Phase 1 (Food Effect):\*\* A randomized, two-period, two-sequence crossover study. Participants are randomized to receive CS0159 either under fasting conditions or after a high-fat meal in the first period, and then cross over to the opposite condition in the second period after a washout. * Phase 2 (DDI with Itraconazole):\*\* Following Phase 1, all participants enter a single-group, fixed-sequence study. They receive itraconazole alone for 5 days, followed by co-administration of CS0159 with itraconazole to assess the inhibitory effect.
Masking: None (open label)
Enrolment: 32 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07429331
Sponsor's protocol ID: CS0159-DDI-CN-I-08
Status last verified: Jun 2026
First submitted: 9 Feb 2026
Last updated: 3 Jun 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of Drug-Drug Interactions Between CS0159 Tablets and Rifampicin/Itraconazole and the Effect of a High-Fat Meal on the Pharmacokinetic Characteristics of CS0159 Tablets in Healthy Adult Participants
ClinicalTrials.gov ID: NCT07429331
Acronym / sponsor ID: CS0159-DDI-CN-I-08
Conditions: Healthy Volunteers
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 32 participants (actual)
Lead sponsor: Cascade Pharmaceuticals, IncUniversity, hospital or other
Study start: 9 Mar 2026 (actual)
Primary completion: 25 Mar 2026 (actual)
Study completion: 1 Apr 2026 (actual)
First posted: 24 Feb 2026 (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.

Design:

Detailed description

Study Background: CS0159 is a novel farnesoid X receptor agonist under development for the treatment of diseases such as nonalcoholic steatohepatitis, primary biliary cholangitis, and primary sclerosing cholangitis. Preclinical studies indicate that CS0159 is primarily metabolized by the CYP3A4 enzyme. According to relevant guidelines, it is necessary to evaluate the impact of CYP3A4 modulators (rifampicin and itraconazole) on the exposure of CS0159, as well as the effect of food on its pharmacokinetics, to guide safe clinical use.
Study Design and Methods: Overall Design: The study consists of two independent parts (Part A and Part B), planning to enroll a total of 32 healthy adult participants (both sexes) aged 18-45. Part A - DDI Study with Rifampicin: A fixed-sequence design is employed. Participants, under fasting conditions, sequentially receive CS0159 monotherapy, rifampicin monotherapy (for 7 consecutive days), and then co-administration of both drugs. Intensive blood sampling is performed for PK analysis. Part B - Food Effect and DDI Study with Itraconazole: Phase 1 (Food Effect): A randomized, open-label, two-period, two-sequence crossover design is used. Participants are randomly divided into two groups to receive a single dose of CS0159 under fasting and high-fat meal conditions, respectively, with a 2-day washout period between the two periods. Phase 2 (DDI Study with Itraconazole): All participants who complete Phase 1 enter this phase. Participants first receive itraconazole after a meal for 5 consecutive days, followed by co-administration of CS0159 with itraconazole after a high-fat meal. Pharmacokinetic and Safety Assessments: Blood samples are collected at scheduled time points during all CS0159 dosing periods (monotherapy or co-administration). CS0159 plasma concentrations are determined using a validated LC-MS/MS method. Throughout the study, adverse events, vital signs, physical examinations, 12-lead ECGs, and laboratory test results are continuously monitored and recorded.
Statistical Methods:

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 3
Model description: This is a two-part, hybrid-design pharmacokinetic study: 1. Part A (n=16): A single-group, fixed-sequence study. All participants receive CS0159 monotherapy (Day 1), followed by rifampicin alone (Days 2-8), and then co-administration of both drugs (Day 9) to assess the inducing effect of rifampicin on CS0159. 2. Part B (n=16): This part consists of two sequential phases within the same cohort: * Phase 1 (Food Effect):** A randomized, two-period, two-sequence crossover study. Participants are randomized to receive CS0159 either under fasting conditions or after a high-fat meal in the first period, and then cross over to the opposite condition in the second period after a washout. * Phase 2 (DDI with Itraconazole):** Following Phase 1, all participants enter a single-group, fixed-sequence study. They receive itraconazole alone for 5 days, followed by co-administration of CS0159 with itraconazole to assess the inhibitory effect.

Arm	Type	Receives
Part A: CS0159 + Rifampicin (DDI)	Experimental	Drug: CS0159 Tablet, Drug: Rifampicin CapsuleHealthy participants receive a single oral dose of CS0159 (4 mg) under fasting conditions on Day 1, followed by oral rifampicin (600 mg) once daily under fasting conditions on Days 2-8, and then co-administration of both drugs under fasting conditions on Day 9.
Part B: CS0159 (Food Effect)	Experimental	Drug: CS0159 TabletThe 16 enrolled participants are randomly assigned to two groups (fasting-fed group and fed-fasting group) in Phase 1, with an equal number in each group. Each group receives a single 4 mg dose per period, with a 2-day washout period (in-house).
Part B: CS0159 + Itraconazole (DDI)	Experimental	Drug: CS0159 Tablet, Drug: Itraconazole CapsuleHealthy participants receive oral itraconazole capsules (200 mg, two capsules of 0.1 g each) once daily in the morning under fed conditions (following a standard meal) from Day 4 to Day 8 (D4~D8), which corresponds to days 2 to 6 after completing the second period of Phase 1. This constitutes 5 consecutive days of itraconazole administration. On the 6th administration day (D9), participants simultaneously take itraconazole capsules (200 mg) and CS0159 tablets (4 mg, two tablets of 2 mg each) under fed conditions (following a high-fat meal).

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Healthy male or female participants aged between 18 and 45 years (inclusive);
Male weight ≥ 50.0 kg, female weight ≥ 45.0 kg; body mass index (BMI) within the range of 19.0 to 26.0 kg/m² (including the threshold values);
Normal renal function (glomerular filtration rate calculated using the CKD-EPI equation ≥ 90 mL/min/1.73 m²);
Participants (including male participants) agree to have no plans for conception from screening until 3 months after the last dose, voluntarily adopt effective contraceptive measures, and have no plans for sperm or egg donation;
Participants fully understand the study purpose, nature, procedures, and potential adverse events, voluntarily agree to participate as subjects, can communicate well with the investigator, comply with all study requirements, and sign the informed consent form before the initiation of any study procedures.

Key exclusion criteria (28 listed)

History of allergic diseases (e.g., asthma, urticaria, eczema, etc.), allergic constitution (e.g., allergy to two or more drugs), or known hypersensitivity to CS0159, rifampicin, itraconazole, or any excipients;
Participants with clinically significant findings, as judged by the investigator, of the following diseases (including but not limited to gastrointestinal, renal, hepatic, neurological, hematological, endocrine, oncological, pulmonary, immunological, psychiatric, or cardiovascular/cerebrovascular diseases) that may complicate protocol implementation or interpretation of study results, or whom the investigator considers to be at risk from participating in the study;
History of susceptibility to pruritus, or presence of conditions such as eczema/atopic dermatitis, neurodermatitis, psoriasis, or other diseases that may cause pruritus;
History of corrected QT interval (QTc) prolongation at screening:
History of acute or chronic bronchospasm (including treated or untreated asthma, chronic obstructive pulmonary disease);

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
CS0159 TabletAlso: Investigational drug (FXR agonist)A novel, selective farnesoid X receptor (FXR) agonist.	Drug	Part A: CS0159 + Rifampicin (DDI), Part B: CS0159 (Food Effect), Part B: CS0159 + Itraconazole (DDI)
Rifampicin CapsuleAlso: CYP3A4 inducer (perpetrator drug)A strong cytochrome P450 3A4 (CYP3A4) enzyme inducer.	Drug	Part A: CS0159 + Rifampicin (DDI)
Itraconazole CapsuleAlso: CYP3A4 inhibitor (perpetrator drug)A strong cytochrome P450 3A4 (CYP3A4) enzyme inhibitor.	Drug	Part B: CS0159 + Itraconazole (DDI)

Primary outcome

Cmax of CS0159
Time frame: Day 1, Day 3, Day 9
Maximum observed plasma concentration (Cmax) of CS0159
AUC0-t of CS0159
Time frame: Day 1, Day 3, Day 9
Area under the plasma concentration-time curve from time zero to the last measurable concentration (AUC0-t) of CS0159
AUC0-∞ of CS0159
Time frame: Day 1, Day 3, Day 9
Area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC0-∞) of CS0159
Tmax of CS0159
Time frame: Day 1, Day 3, Day 9
Time to reach Cmax (Tmax)
t1/2 of CS0159
Time frame: Day 1, Day 3, Day 9
terminal elimination half-life (t1/2)
CL/F of CS0159
Time frame: Day 1, Day 3, Day 9
apparent oral clearance (CL/F)

1 secondary outcome

Incidence of Treatment-Emergent Adverse Events (TEAEs)
Time frame: From screening until 7 days after the last 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 3 Jun 2026.
Individual participant dataSharing planned: No

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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.

Yun Liu principal investigator

Shanghai Xuhui District Central Hospital

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 CS0159 Tablet, Rifampicin Capsule and Itraconazole Capsule in people with Healthy Volunteers, 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 5 inclusion and 28 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 3 Jun 2026. 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?

Cmax of CS0159 (time frame: Day 1, Day 3, Day 9). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07429331.

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 3 Jun 2026.