Drug Interaction and Food Effect Study of CS0159 (NCT07429331) | Clinical Trial Compass
Not Yet RecruitingPhase 1
Drug Interaction and Food Effect Study of CS0159
32 participantsStarted 2026-03
Plain-language 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.
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.) .
Who can participate
Age range18 Years – 45 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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.
✕. 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;