A Study to Test How BI 3000202 is Taken up in the Blood of People With and Without Liver Problems

Part of paid clinical trials in San Antonio, Texas.

Sponsor
Boehringer Ingelheim
Study ID
NCT07486102
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Healthy
  • Hepatic Impairment

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Accepted

Interventions

Study Details

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.

Key Dates

Start date
May 1, 2026
Status verified
May 2026
Primary completion
Feb 26, 2027
Completion
Feb 27, 2027

Study Design

Enrollment
44 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Participants with mild hepatic impairment (Child-Pugh A)
  • Experimental: Participants with moderate hepatic impairment (Child-Pugh B)
  • Experimental: Participants with severe hepatic impairment (Child-Pugh C)
  • Experimental: Participants with normal hepatic function

Primary Outcome Measure

Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) [ Time Frame: Up to 8 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
American Research Corporation at the Texas Liver InstituteSan AntonioTexas78215
Boehringer Ingelheim
[email protected]
833-602-2368

Find similar trials in San Antonio, TX

By research site
American Research Corporation at the Texas Liver Institute· San Antonio, TX

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