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

Trial Title: 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

NCT ID: NCT05741372

Condition: Liver Cirrhosis

Conditions: Official terms:
Liver Cirrhosis
Fibrosis
Metformin
Digoxin
Furosemide
Rosuvastatin Calcium

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Non-Randomized

Intervention model: Parallel Assignment

Primary purpose: Other

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Rosuvastatin
Description: Rosuvastatin
Arm group label: Group 1: Healthy participants
Arm group label: Group 2: F4 Child-Turcotte-Pugh class A (Child-Pugh A) subjects (compensated)
Arm group label: Group 3: F4 Child-Turcotte-Pugh class B (Child-Pugh B) subjects (decompensated)

Intervention type: Drug
Intervention name: Digoxin
Description: Digoxin
Arm group label: Group 1: Healthy participants
Arm group label: Group 2: F4 Child-Turcotte-Pugh class A (Child-Pugh A) subjects (compensated)
Arm group label: Group 3: F4 Child-Turcotte-Pugh class B (Child-Pugh B) subjects (decompensated)

Intervention type: Drug
Intervention name: Metformin hydrochlorid
Description: Metformin hydrochloride
Arm group label: Group 1: Healthy participants
Arm group label: Group 2: F4 Child-Turcotte-Pugh class A (Child-Pugh A) subjects (compensated)
Arm group label: Group 3: F4 Child-Turcotte-Pugh class B (Child-Pugh B) subjects (decompensated)

Intervention type: Drug
Intervention name: Furosemide
Description: Furosemide
Arm group label: Group 1: Healthy participants
Arm group label: Group 2: F4 Child-Turcotte-Pugh class A (Child-Pugh A) subjects (compensated)
Arm group label: Group 3: F4 Child-Turcotte-Pugh class B (Child-Pugh B) subjects (decompensated)

Summary: This study is open to healthy adults and adults with liver cirrhosis. The purpose of this study is to compare how different medicines are handled by the body in people with and without liver cirrhosis. The study measures if the approved medicines rosuvastatin, digoxin, metformin, and furosemide are processed differently in people with liver cirrhosis than in people without liver cirrhosis. This study will help to understand how new medicines being developed are handled by the body in people with liver cirrhosis. There are 3 groups in this study: people without liver cirrhosis, people with mild liver cirrhosis, and people with moderate liver cirrhosis. All participants get 1 dose each of rosuvastatin, digoxin, metformin, and furosemide by mouth. The participants with liver cirrhosis continue their regular treatment for the condition during the study. Participants are in the study for about 1 month. During this time, they visit the study site 4 times. For 1 of the visits, they stay overnight for 2 nights at the study site. To assess the main study endpoint, the doctors take frequent blood samples from the participants. The doctors also regularly check participants' health and take note of any unwanted effects.

Criteria for eligibility:
Criteria:
Inclusion criteria Healthy subjects and F4 liver cirrhosis patients: - Signed and dated written informed consent in accordance with the International Conference on Harmonization-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial - Either male subject, or female subject who meets any of the following criteria for a highly effective contraception from at least 30 days before the first administration of trial medication until 30 days after trial completion: - Use of combined (estrogen and progestogen containing) hormonal contraception that prevents ovulation (oral, intravaginal, or transdermal), plus condom - Use of progestogen-only hormonal contraception that inhibits ovulation (only injectables or implants), plus condom - Use of intrauterine device (IUD) or intrauterine hormone-releasing system (IUS) - Sexually abstinent - A vasectomized sexual partner who received medical assessment of the surgical success (documented absence of sperm) and provided that the partner is the sole sexual partner of the trial participant - Surgically sterilized (including hysterectomy) - Postmenopausal, defined as no menses for 1 year without an alternative medical cause (in questionable cases a blood sample with levels of follicle-stimulating hormone (FSH) above 40 units per liter (U/L) and estradiol below 30 nanograms per liter (ng/L) is confirmatory) - Not taking any components in the cocktail within 4 weeks of enrolment Healthy subjects only: - Healthy male or female subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests - Age of 18 to 75 years (inclusive) - Body mass index (BMI) of 18.5 to 35 kilograms per meter squared (kg/m2) (inclusive). A BMI of ≥ 30 is no exclusion criterion when the subject can be considered healthy apart from the elevated BMI - further inclusion criteria apply F4 liver cirrhosis patients only: - Male and female subjects, 18 to 75 years - BMI of 18.5 to 40.0 kg/m2 (inclusive) - Stable treatment for at least 4 weeks prior to taking the cocktail - further inclusion criteria apply Healthy subjects and F4 liver cirrhosis patients: - Subjects already taking digoxin, furosemide, metformin or rosuvastatin within 4 weeks of enrolment into the study. Furthermore, patients taking ezetimibe, fibrates, or the maximal dose (per Summary of Product Characteristics (SmPC)) of any statin are excluded from this study. - Subjects with any other condition that would preclude administration of digoxin, furosemide, metformin or rosuvastatin (i.e., contraindicated as per SmPC), such as hypersensitivity to active ingredient or any of the excipients or to sulphonamides, hypovolemia or dehydration, and partial obstructions of urinary outflow (e.g., prostatic hypertrophy) - Repeated measurement of systolic blood pressure outside the range of 90 to 150 millimeter of mercury (mmHg), diastolic blood pressure outside the range of 50 to 95 mmHg, or pulse rate outside the range of 60 to 90 beats per minute (bpm) - Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair) - Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders - History of relevant orthostatic hypotension, fainting spells, or blackouts - Relevant (other than Hepatitis B virus (HBV) or Hepatitis C virus (HCV)) chronic or acute infections (including an ongoing severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection) - Patients receiving antiviral therapy at the time of inclusion into the trial - further exclusion criteria apply

Gender: All

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Locations:

Facility:
Name: CRS Clinical Research Services Mannheim GmbH

Address:
City: Mannheim
Zip: 68167
Country: Germany

Status: Recruiting

Contact:
Last name: Boehringer Ingelheim

Phone: 08007234742
Email: deutschland@bitrialsupport.com

Start date: April 25, 2023

Completion date: July 28, 2025

Lead sponsor:
Agency: Boehringer Ingelheim
Agency class: Industry

Source: Boehringer Ingelheim

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05741372
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