A Study to Compare How Different Medicines (Rosuvastatin, Digoxin, Metformin, and Furosemide) Are Handled by the Body of Healthy People and People With Liver Cirrhosis

Not Applicable

Completed

• Conditions: Liver Cirrhosis
• Interventions: Drug: Rosuvastatin; Drug: Digoxin; Drug: Metformin hydrochlorid; Drug: Furosemide

• Registration Number: NCT05741372
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

The main trial objective, is to ascertain whether the transport activity, given by the maximum concentration (Cmax) and the area under the curve (AUC0-24) values for the different components in the transporter cocktail are similar or different in F4 liver cirrhosis patients on standard therapy compared to healthy subjects.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-02-14
• Study First Submitted QC: 2023-02-14
• Study First Posted: 2023-02-23
• Study Start: 2023-09-07
• Primary Completion: 2024-12-18
• Study Completion: 2024-12-30
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-21
• Last Update Posted: 2025-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2: F4 Child-Turcotte-Pugh class A (Child-Pugh A) subjects (compensated)	Digoxin	Every participant receives a cocktail of Rosuvastatin, Digoxin, Metformin hydrochlorid, Furosemide. Compensated=without any disease symptoms
Group 2: F4 Child-Turcotte-Pugh class A (Child-Pugh A) subjects (compensated)	Metformin hydrochlorid	Every participant receives a cocktail of Rosuvastatin, Digoxin, Metformin hydrochlorid, Furosemide. Compensated=without any disease symptoms
Group 3: F4 Child-Turcotte-Pugh class B (Child-Pugh B) subjects (decompensated)	Metformin hydrochlorid	Every participant receives a cocktail of Rosuvastatin, Digoxin, Metformin hydrochlorid, Furosemide. Decompensated= with disease symptoms like aszites, variceal bleeding, hepatic encephalopathy, hepato-renal syndrome
Group 1: Healthy participants	Metformin hydrochlorid	Every participant receives a cocktail of Rosuvastatin, Digoxin, Metformin hydrochlorid, Furosemide.
Group 1: Healthy participants	Rosuvastatin	Every participant receives a cocktail of Rosuvastatin, Digoxin, Metformin hydrochlorid, Furosemide.
Group 1: Healthy participants	Digoxin	Every participant receives a cocktail of Rosuvastatin, Digoxin, Metformin hydrochlorid, Furosemide.
Group 2: F4 Child-Turcotte-Pugh class A (Child-Pugh A) subjects (compensated)	Rosuvastatin	Every participant receives a cocktail of Rosuvastatin, Digoxin, Metformin hydrochlorid, Furosemide. Compensated=without any disease symptoms
Group 1: Healthy participants	Furosemide	Every participant receives a cocktail of Rosuvastatin, Digoxin, Metformin hydrochlorid, Furosemide.
Group 2: F4 Child-Turcotte-Pugh class A (Child-Pugh A) subjects (compensated)	Furosemide	Every participant receives a cocktail of Rosuvastatin, Digoxin, Metformin hydrochlorid, Furosemide. Compensated=without any disease symptoms
Group 3: F4 Child-Turcotte-Pugh class B (Child-Pugh B) subjects (decompensated)	Rosuvastatin	Every participant receives a cocktail of Rosuvastatin, Digoxin, Metformin hydrochlorid, Furosemide. Decompensated= with disease symptoms like aszites, variceal bleeding, hepatic encephalopathy, hepato-renal syndrome
Group 3: F4 Child-Turcotte-Pugh class B (Child-Pugh B) subjects (decompensated)	Digoxin	Every participant receives a cocktail of Rosuvastatin, Digoxin, Metformin hydrochlorid, Furosemide. Decompensated= with disease symptoms like aszites, variceal bleeding, hepatic encephalopathy, hepato-renal syndrome
Group 3: F4 Child-Turcotte-Pugh class B (Child-Pugh B) subjects (decompensated)	Furosemide	Every participant receives a cocktail of Rosuvastatin, Digoxin, Metformin hydrochlorid, Furosemide. Decompensated= with disease symptoms like aszites, variceal bleeding, hepatic encephalopathy, hepato-renal syndrome

Primary Outcome Measures

Name	Time	Method
Maximum measured concentration of the analyte in plasma) for each component of the transporter cocktail: digoxin, furosemide, metformin, and rosuvastatin (Cmax)	Up to 24 hours
Area under the concentration time curve of the analyte in plasma over the time interval from 0 to 24 hours) for each component of the transporter cocktail: digoxin, furosemide, metformin, and rosuvastatin (AUC0-24)	Up to 24 hours

Trial Locations

Locations (1)

CRS Clinical Research Services Mannheim GmbH; 🇩🇪 Mannheim, Germany