A Study to Test How BI 690517 is Taken up in the Body of People With and Without Liver Problems (NCT05731908) | Clinical Trial Compass
CompletedPhase 1
A Study to Test How BI 690517 is Taken up in the Body of People With and Without Liver Problems
United States28 participantsStarted 2023-02-21
Plain-language summary
The main objective of this trial is to assess the effect of mild and moderate hepatic impairment (Child-Pugh classification A and B) on the pharmacokinetics, safety, and tolerability of BI 690517 in comparison with a control group with normal hepatic function.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male or female subjects aged at least 18 years at screening
* Body mass index of 18.5 to 36.0 kg/m2 (inclusive)
* Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.
* Women of childbearing potential1 and men able to father a child must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly.
Inclusion criteria applying only to participants with impaired hepatic function:
* Hepatic impairment classified as Child-Pugh A (score 5-6 points) or Child-Pugh B (score 7-9 points)
* Absence of clinically significant abnormalities, as based on a complete medical history including a full physical examination, vital signs (Blood pressure, Pulse rate), 12-lead Electric Cardiogram, and clinical laboratory tests at both screening and admission to trial site, with the exception of findings that in the opinion of the investigator are consistent with the participant's hepatic impairment.
* Medication and/or treatment regimens must have been stable (i.e., no dose adjustments) for at least 4 weeks prior to the screening period and should be kept stable until study completion. Fluctuating treatment regimens may be considered for inclusion on a case-by-case basis if the underlying disease is under control in the opinion of the investigator and must be agreed to by both the investig…
What they're measuring
1
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)
Timeframe: Up to 4 days
2
Maximum measured concentration of the analyte in plasma (Cmax)