An interventional study of Caffeine and Warfarin sodium in Liver Cirrhosis, sponsored by Boehringer Ingelheim. Completed at 1 site in Germany. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-09-10.
Sponsored by Boehringer Ingelheim · Not applicable, Interventional, and Other
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 caffeine, warfarin,omeprazole, metoprolol, and midazolam 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 caffeine, warfarin, omeprazole, metoprolol, and midazolam 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 5 times. For 1 of the visits, participants 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.
1,642 studies on the registry are indexed under Liver Cirrhosis; 358 are open to participants now.
This study's enrollment of 4 is below the median of 72 across 995 interventional studies indexed under Liver Cirrhosis.
Browse Liver Cirrhosis studies →Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.
Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.
Counted across the registry records on this site, refreshed daily.
Healthy subjects and F4 liver cirrhosis patients:
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:
Healthy subjects only:
F4 liver cirrhosis patients only
Exclusion criteria
Healthy subjects and F4 liver cirrhosis patients:
Every participant receives a cocktail of Caffeine, Warfarin sodium, Omeprazole, Metoprolol, Midazolam.
Drug: Caffeine · Drug: Warfarin sodium · Drug: Omeprazole · Drug: Metoprolol · Drug: Midazolam
Every participant receives a cocktail of Caffeine, Warfarin sodium, Omeprazole, Metoprolol, Midazolam. Compensated=without any disease symptoms
Drug: Caffeine · Drug: Warfarin sodium · Drug: Omeprazole · Drug: Metoprolol · Drug: Midazolam
Every participant receives a cocktail of Caffeine, Warfarin sodium, Omeprazole, Metoprolol, Midazolam. Decompensated= with disease symptoms like aszites, variceal bleeding, hepatic encephalopathy, hepato-renal syndrome
Drug: Caffeine · Drug: Warfarin sodium · Drug: Omeprazole · Drug: Metoprolol · Drug: Midazolam
Caffeine
Warfarin sodium
Omeprazole
Metoprolol
Midazolam
Area Under the Concentration Time Curve of Caffeine, Omeprazole and Metoprolol in Plasma Over the Time Interval From 0 to 24 Hours (AUC0-24)
Area under the concentration time curve of caffeine, omeprazole and metoprolol in plasma over the time interval from 0 to 24 hours (AUC0-24) is reported.
Time frame: 2 hours before drug administration and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48-72 and 96 (+/-12) hours after drug administration.
Area Under the Concentration Time Curve of Midazolam in Plasma Over the Time Interval From 0 to 24 Hours (AUC0-24)
Area under the concentration time curve of midazolam in plasma over the time interval from 0 to 24 hours (AUC0-24) is reported.
Time frame: 2 hours before drug administration and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48-72 and 96 (+/-12) hours after drug administration.
Area Under the Concentration Time Curve of R-warfarin and S-warfarin in Plasma Over the Time Interval From 0 to 96 Hours (AUC0-96)
Area under the concentration time curve of R-warfarin and S-warfarin in plasma over the time interval from 0 to 96 hours (AUC0-96) is reported.
Time frame: 2 hours before drug administration and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48-72 and 96 (+/-12) hours after drug administration.
Maximum Measured Concentration of Caffeine, Omeprazole, Metoprolol, R-warfarin and S-warfarin in Plasma (Cmax)
Maximum measured concentration of caffeine, omeprazole, metoprolol, R-warfarin and S-warfarin in plasma (Cmax) is reported.
Time frame: 2 hours before drug administration and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48-72 and 96 (+/-12) hours after drug administration.
Maximum Measured Concentration of Midazolam in Plasma (Cmax)
Maximum measured concentration of midazolam in plasma (Cmax) is reported.
Time frame: 2 hours before drug administration and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48-72 and 96 (+/-12) hours after drug administration.
The study aimed to investigate whether the metabolic activity of selected CYP isozymes differs between F4 liver cirrhosis patients receiving standard therapy and healthy subjects. It was planned that 12 healthy subjects, 12 compensated F4 Child-Pugh A patients and a minimum of 6 decompensated Child-Pugh B patients following clinical confirmation enter the study. Due to insufficient enrollment only 4 patients, all from Child-Pugh A cohort, were entered into the trial.
| Milestone | Child-Pugh A |
|---|---|
| Started | 4 |
| Completed | 4 |
| Not completed | 0 |
Area under the concentration time curve of caffeine, omeprazole and metoprolol in plasma over the time interval from 0 to 24 hours (AUC0-24) is reported.
| Hour*nanogram/milliliter | Child-Pugh A |
|---|---|
| Caffeine | 20600 ± 37.3 |
| Omeprazole | 1520 ± 164 |
| Metoprolol | 287 ± 71.1 |
Area under the concentration time curve of midazolam in plasma over the time interval from 0 to 24 hours (AUC0-24) is reported.
| Hour*picogram/milliliter | Child-Pugh A |
|---|---|
| Area Under the Concentration Time Curve of Midazolam in Plasma Over the Time Interval From 0 to 24 Hours (AUC0-24) | 31200 ± 51.1 |
Area under the concentration time curve of R-warfarin and S-warfarin in plasma over the time interval from 0 to 96 hours (AUC0-96) is reported.
| Hour*nanogram/milliliter | Child-Pugh A |
|---|---|
| R-warfarin | 11200 ± 18.3 |
| S-warfarin | 5350 ± 24.7 |
Maximum measured concentration of caffeine, omeprazole, metoprolol, R-warfarin and S-warfarin in plasma (Cmax) is reported.
| Nanogram/milliliter | Child-Pugh A |
|---|---|
| Caffeine | 2650 ± 23.4 |
| Omeprazole | 487 ± 67.9 |
| Metoprolol | 73.9 ± 72.3 |
| R-warfarin | 225 ± 26.3 |
| S-warfarin | 226 ± 26.8 |
Maximum measured concentration of midazolam in plasma (Cmax) is reported.
| Picogram/milliliter | Child-Pugh A |
|---|---|
| Maximum Measured Concentration of Midazolam in Plasma (Cmax) | 9520 ± 38.9 |
Collected over Adverse events and all-cause mortality: From administration of drug cocktail plus residual effect period, up to 9 days.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Child-Pugh A | 0/4 (0%) | 0/4 (0%) | 2/4 (50%) |
| Event | Child-Pugh A |
|---|---|
| Atrioventricular block first degreeCardiac disorders | 1/4 |
| Back painMusculoskeletal and connective tissue disorders | 1/4 |
Treated Set (TS): All subjects who signed informed consent and were treated with study drug.
| Age, Continuous(Years) | Child-Pugh A |
|---|---|
| Mean | 66.8 ± 7.1 |
| Sex: Female, Male(Participants) | Child-Pugh A |
|---|---|
| Female | 3 |
| Male | 1 |
| Ethnicity (NIH/OMB)(Participants) | Child-Pugh A |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 4 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Child-Pugh A |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 4 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g., studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https:// www.mystudywindow.com/msw/datatransparency
This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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Boehringer Ingelheim