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Official title A Study to Test How BI 3000202 is Taken up in the Blood of People With and Without Liver Problems
ClinicalTrials.gov ID: NCT07486102
What this study is testing
What is BI 3000202?
BI 3000202 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for healthy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is open to healthy people and people with liver problems. Adults between 18 and 80 years can participate.
- Phase 1: an early, usually small safety study
- Time commitment: about 1 month
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- Male and female participants. Women of childbearing potential must be willing and able to use a highly effective method of contraception per ICH M3...
- Body mass index (BMI) of 18.5-42.0 kg/m² (inclusive) at Visit 1. Cohort 4 (participants with normal hepatic function) \- Clinically healthy based on...
- Hepatic impairment that meets the criteria for Child-Pugh classes A (Cohort 1), B (Cohort 2), or C (Cohort 3).
You likely can't join if
- 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...
- Have received stem cell transplantation.
- Have received live or attenuated vaccination within 8 weeks prior to Visit 2.
- Have received Bacillus Calmette-Guérin (BCG) vaccines ≤1 year prior to Visit 2.
See the full eligibility 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...
- Body mass index (BMI) of 18.5-42.0 kg/m² (inclusive) at Visit 1. Cohort 4 (participants with normal hepatic function) \- Clinically healthy based on medical history, physical examination, vital signs, Electrocardiogram...
- Hepatic impairment that meets the criteria for Child-Pugh classes A (Cohort 1), B (Cohort 2), or C (Cohort 3).
- Hepatic decompensation therapies (e.g., diuretics for ascites, lactulose for hepatic encephalopathy, nonselective betablockers for portal hypertension) need to comply with following requirements:
- No new initiation or permanent discontinuation is permitted within 3 months prior to Visit 1.
- Major dose modifications (\>50% change from baseline) within 4 weeks prior to Visit 1 are exclusionary.
- Minor titrations consistent with standard clinical management are permitted, provided the investigator confirms that the patient's underlying condition is clinically controlled. Cases involving fluctuating hepatic...
- 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...
- Have received stem cell transplantation.
- Have received live or attenuated vaccination within 8 weeks prior to Visit 2.
- Have received Bacillus Calmette-Guérin (BCG) vaccines ≤1 year prior to Visit 2.
- Presence of relevant chronic or acute infections, including active systemic infection requiring antibiotics within 6 weeks prior to Visit 2.
- Active or latent tuberculosis (TB).
- Participants with active TB will always be excluded.
- Participants with latent TB will be excluded if tested positive for Interferon-gamma release assay (IGRA) (QuantiFERON®-TB Gold Plus or T-SPOT®.TB) at Visit 1, not having completed appropriate treatment per local...
- Participants with indeterminate QuantiFERON®-TB Gold Plus or borderline or invalid T-SPOT®. TB may be retested with IGRA (once) and will be excluded if retesting is inconclusive or positive.
- Under exceptional circumstances and only after discussion with the sponsor, purified protein derivative (PPD) skin test can be performed if IGRA is not available. A PPD ≥10 mm (≥5 mm if receiving ≥15 mg/day prednisone...
The study team makes the final eligibility decision.
Where it's taking place
- San Antonio, Texas, United States
Compensation & support
Compensation likely.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 1 month per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Antonio, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.