A Phase I, Open-label, Single-dose Study to Evaluate the Effect of Hepatic Impairment on the Pharmacokinetics, Safety, and Tolerability of BI 3000202 in Adults
Boehringer Ingelheim
Summary
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
- Age range
- 18–80 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria : * 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 adminis…
Interventions
- DrugBI 3000202
BI 3000202
Location
- American Research Corporation at the Texas Liver InstituteSan Antonio, Texas