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COMPLETED
NCT07429331
PHASE1

Drug Interaction and Food Effect Study of CS0159

Sponsor: Cascade Pharmaceuticals, Inc

View on ClinicalTrials.gov

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.) .

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

Key Details

Gender

All

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

32

Start Date

2026-03-09

Completion Date

2026-04-01

Last Updated

2026-06-03

Healthy Volunteers

Yes

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.

Locations (1)

Shanghai Xuhui Central Hospital

Shanghai, Shanghai Municipality, China