JOURNAL ONKOLOGIE – STUDIE

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

Studien-Informationen Einschlusskriterien Studien-Rationale Studien-Arme Geprüfte Regime

Rekrutierend

NCT-Nummer:
NCT05741372

Studienbeginn:
April 2023

Letztes Update:
14.02.2024

Wirkstoff:
Rosuvastatin, Digoxin, Metformin hydrochlorid, Furosemide

Indikation (Clinical Trials):
Liver Cirrhosis, Fibrosis

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Boehringer Ingelheim

Collaborator:
-

Kontakt

Boehringer Ingelheim
Kontakt:
Phone: 1-800-243-0127
E-Mail: clintriage.rdg@boehringer-ingelheim.com» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

CRS Clinical Research Services Mannheim GmbH
68167 Mannheim
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Boehringer Ingelheim
Phone: 08007234742
E-Mail: deutschland@bitrialsupport.com» Ansprechpartner anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

1. 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) (Time Frame - Up to 24 hours)

2. Maximum measured concentration of the analyte in plasma) for each component of the transporter cocktail: digoxin, furosemide, metformin, and rosuvastatin (Cmax) (Time Frame - Up to 24 hours)

Studien-Arme

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

Geprüfte Regime

Rosuvastatin:
Rosuvastatin
Digoxin:
Digoxin
Metformin hydrochlorid:
Metformin hydrochloride
Furosemide:
Furosemide

Quelle: ClinicalTrials.gov

Sie können folgenden Inhalt einem Kollegen empfehlen:

"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"

Bitte tragen Sie auch die Absenderdaten vollständig ein, damit Sie der Empfänger erkennen kann.

Die mit (*) gekennzeichneten Angaben müssen eingetragen werden!