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Drug Interaction and Food Effect Study of CS0159

NCT07429331 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2026-02-24

No results posted yet for this study

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.) .

Conditions

  • Healthy Volunteers

Interventions

DRUG

CS0159 Tablet

A novel, selective farnesoid X receptor (FXR) agonist.

DRUG

Rifampicin Capsule

A strong cytochrome P450 3A4 (CYP3A4) enzyme inducer.

DRUG

Itraconazole Capsule

A strong cytochrome P450 3A4 (CYP3A4) enzyme inhibitor.

Sponsors & Collaborators

  • Cascade Pharmaceuticals, Inc

    lead OTHER

Principal Investigators

  • Yun Liu · Shanghai Xuhui District Central Hospital

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-03-31
Primary Completion
2027-02-28
Completion
2027-02-28
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07429331 on ClinicalTrials.gov