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A Study to Test How BI 3000202 is Taken up in the Blood of People With and Without Liver Problems Phase 1 44
All participants take 1 tablet of BI 3000202. Participants with liver problems may also continue their regular treatment for their liver condition.
Participants a...
Show MoreA 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
- 1509-0036
- U1111-1324-2054 (Registry Identifier) (WHO International Clinical Trials Registry Platform (ICTRP))
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalParticipants with mild hepatic impairment (Child-Pugh A) | BI 3000202 BI 3000202 |
ExperimentalParticipants with moderate hepatic impairment (Child-Pugh B) | BI 3000202 BI 3000202 |
ExperimentalParticipants with severe hepatic impairment (Child-Pugh C) | BI 3000202 BI 3000202 |
ExperimentalParticipants with normal hepatic function | BI 3000202 BI 3000202 |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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) | Up to 8 days | |
Maximum measured concentration of the analyte in plasma (Cmax) | Up to 8 days |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) | Up to 8 days |
- 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. Male participants do not require contraception.
- Body mass index (BMI) of 18.5-42.0 kg/m² (inclusive) at Visit 1.
Inclusion criteria Cohort 4 (participants with normal hepatic function)
- Clinically healthy based on medical history, physical examination, vital signs, Electrocardiogram (ECG), and laboratory tests at Visit 1.
Inclusion criteria Cohorts 1, 2 and 3 (participants with hepatic impairment)
- Hepatic impairment that meets the criteria for Child-Pugh classes A (Cohort 1), B (Cohort 2), or C (Cohort 3).
- Medication and/or treatment regimens must be stable (i.e. no dose adjustments) for at least 4 weeks prior to Visit 1 and should be kept stable until end of study (EOS). 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 investigator and the sponsor's medical monitor.
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.
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 14 days 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 practice/guidelines for TB within the past 3 years and at least 1 month before Visit 2.
- 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 or other immunosuppressant) is considered positive. Participants with a positive PPD are excluded unless they have completed treatment as above.
Further exclusion criteria apply.
Boehringer IngelheimTexas