A Study to Test How BI 3000202 is Taken up in the Blood of People With and Without Liver Problems
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-80
SponsorBoehringer Ingelheim
About this trial
This study is open to healthy people and people with liver problems. Adults between 18 and 80 years can participate. The purpose of this study is to compare how a medicine called BI 3000202 is handled by the body in people with and without liver problems.
All participants take 1 tablet of BI 3000202. Participants with liver problems may also continue their regular treatment for their liver condition.
Participants are in the study for about 1 month. During this time, participants visit the study site about 11 times. Where possible, some of these visits may happen by phone. For some visits, participants stay at the study site overnight. Doctors regularly test the amount of BI 3000202 in the blood and check for any health problems.
Eligibility criteria
Qualifiers
Adult participants ≥18 years and ≤80 years of age at Visit 1.
Signed and dated written informed consent in accordance with International Council for Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to participation in the trial.
Male and female participants. Women of childbearing potential must be willing and able to use a highly effective method of contraception per ICH M3 (R2) that results in a low failure rate (i.e. <1% per year when used consistently and correctly) for the duration of the trial until at least 14 days after drug administration. Throughout the trial and for a period of at least 14 days after investigational medicinal product (IMP) administration, male participants with sexual partners who are women of child-bearing potential must use condoms or practice complete abstinence.
Body mass index (BMI) of 18.5-42.0 kg/m² (inclusive) at Visit 1.
Disqualifiers
Participation in another clinical trial within 30 days or 5 half-lives of the investigational drug (whichever is longer) prior Visit 2.
Known hypersensitivity to BI 3000202 or any of its excipients.
Any documented active or suspected malignancy or history of malignancy within 5 years prior to Visit 1 (except appropriately treated basal cell carcinoma or squamous cell carcinoma of the skin, or in situ carcinoma of uterine cervix (treated >3 years); patients with a remote history of malignancy (≥5 years prior) may be considered and must be discussed with sponsor on a case-by-case basis.
Have received stem cell transplantation.
Trial design
Treatments tested in this trial
- BI 3000202
Treatment groups
44 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov