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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05741385
Other study ID # 0352-2190
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 25, 2023
Est. completion date January 27, 2025

Study information

Verified date January 2024
Source Boehringer Ingelheim
Contact Boehringer Ingelheim
Phone 1-800-243-0127
Email clintriage.rdg@boehringer-ingelheim.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The main trial objective is to ascertain whether the metabolism activity of selected cytochrome (CYP) isozymes caffeine (CYP1A2 probe drug), S-warfarin (CYP2C9 probe drug), omeprazole (CYP2C19 probe drug), metopolol (CYP2D6 probe drug), and midazolam (CYP3A probe drug) are similar or different in F4 liver cirrhosis patients on standard therapy compared to healthy subjects.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date January 27, 2025
Est. primary completion date January 14, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion criteria Healthy subjects and F4 liver cirrhosis patients: - Signed and dated written informed consent in accordance with the International Conference on Harmonisation-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 vasectomised 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 sterilised (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 (except from caffeine: methylxanthine-containing drinks or foods such as coffee, tea, cola, energy drinks, or chocolate are not allowed within 48 hours (h) before and during the inhouse confinement at the trial site) 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. Furthermore, patients can only be included into the trial a) if they are in constant specialist care at the timepoint of enrollment into the study and b) if they are willing to continue to be in specialist care after participation in the 0352.2190 study - further inclusion criteria apply Exclusion criteria Healthy subjects and F4 liver cirrhosis patients: - Subjects already taking any components in the cocktail within 4 weeks before cocktail administration (except from caffeine: methylxanthine-containing drinks or foods such as coffee, tea, cola, energy drinks, or chocolate are not allowed within 48 h before and during the in-house confinement at the trial site) - Subjects with any other condition that would preclude administration of caffeine, warfarin, omeprazole, metoprolol, and midazolam (i.e., contraindicated as per Summary of Product Characteristics (SmPC)), such as hypersensitivity to active ingredient or any of the excipients or to any beta receptor blockers - 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 50 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Caffeine
Caffeine
Warfarin sodium
Warfarin sodium
Omeprazole
Omeprazole
Metoprolol
Metoprolol
Midazolam
Midazolam

Locations

Country Name City State
Germany CRS Clinical Research Services Mannheim GmbH Mannheim

Sponsors (1)

Lead Sponsor Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Area under the concentration time curve of the analyte in plasma over the time interval from 0 to 24 hours (AUC0-24) for caffeine, omeprazole, metoprolol, and midazolam Up to 108 hours
Primary Area under the concentration time curve of warfarin, R-warfarin and S-warfarin in plasma over the time interval from 0 to 96 hours (AUC0-96) Up to 108 hours
Primary Maximum measured concentration of the analyte in plasma (Cmax) for each component of the CYP-cocktail: caffeine, R-warfarin, S-warfarin, omeprazole, metoprolol, and midazolam Up to 108 hours
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