Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 3:49 AM
Study NCT ID:
NCT07486102
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-24
First Post:
2026-03-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Test How BI 3000202 is Taken up in the Blood of People With and Without Liver Problems
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 44}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2027-02-27', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-20', 'studyFirstSubmitDate': '2026-03-17', 'studyFirstSubmitQcDate': '2026-03-17', 'lastUpdatePostDateStruct': {'date': '2026-03-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-02-26', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'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)', 'timeFrame': 'Up to 8 days'}, {'measure': 'Maximum measured concentration of the analyte in plasma (Cmax)', 'timeFrame': 'Up to 8 days'}], 'secondaryOutcomes': [{'measure': 'Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)', 'timeFrame': 'Up to 8 days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy', 'Hepatic Impairment']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.clinicalstudies.boehringer-ingelheim.com/msw/datatransparency', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': '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.\n\nAll participants take 1 tablet of BI 3000202. Participants with liver problems may also continue their regular treatment for their liver condition.\n\nParticipants 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria :\n\n* Adult participants ≥18 years and ≤80 years of age at Visit 1.\n* 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.\n* 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.\n* Body mass index (BMI) of 18.5-42.0 kg/m² (inclusive) at Visit 1.\n\nInclusion criteria Cohort 4 (participants with normal hepatic function)\n\n\\- Clinically healthy based on medical history, physical examination, vital signs, Electrocardiogram (ECG), and laboratory tests at Visit 1.\n\nInclusion criteria Cohorts 1, 2 and 3 (participants with hepatic impairment)\n\n* Hepatic impairment that meets the criteria for Child-Pugh classes A (Cohort 1), B (Cohort 2), or C (Cohort 3).\n* 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.\n\nExclusion Criteria :\n\n* Participation in another clinical trial within 30 days or 5 half-lives of the investigational drug (whichever is longer) prior Visit 2.\n* Known hypersensitivity to BI 3000202 or any of its excipients.\n* 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.\n* Have received stem cell transplantation.\n* Have received live or attenuated vaccination within 8 weeks prior to Visit 2.\n* Have received Bacillus Calmette-Guérin (BCG) vaccines ≤1 year prior to Visit 2.\n* Presence of relevant chronic or acute infections, including active systemic infection requiring antibiotics within 14 days prior to Visit 2.\n* Active or latent tuberculosis (TB).\n\n * Participants with active TB will always be excluded.\n * 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.\n * 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.\n * 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.\n\nFurther exclusion criteria apply."}, 'identificationModule': {'nctId': 'NCT07486102', 'briefTitle': 'A Study to Test How BI 3000202 is Taken up in the Blood of People With and Without Liver Problems', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '1509-0036'}, 'secondaryIdInfos': [{'id': 'U1111-1324-2054', 'type': 'REGISTRY', 'domain': 'WHO International Clinical Trials Registry Platform (ICTRP)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Participants with mild hepatic impairment (Child-Pugh A)', 'interventionNames': ['Drug: BI 3000202']}, {'type': 'EXPERIMENTAL', 'label': 'Participants with moderate hepatic impairment (Child-Pugh B)', 'interventionNames': ['Drug: BI 3000202']}, {'type': 'EXPERIMENTAL', 'label': 'Participants with severe hepatic impairment (Child-Pugh C)', 'interventionNames': ['Drug: BI 3000202']}, {'type': 'EXPERIMENTAL', 'label': 'Participants with normal hepatic function', 'interventionNames': ['Drug: BI 3000202']}], 'interventions': [{'name': 'BI 3000202', 'type': 'DRUG', 'description': 'BI 3000202', 'armGroupLabels': ['Participants with mild hepatic impairment (Child-Pugh A)', 'Participants with moderate hepatic impairment (Child-Pugh B)', 'Participants with normal hepatic function', 'Participants with severe hepatic impairment (Child-Pugh C)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78215', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'contacts': [{'name': 'Boehringer Ingelheim', 'role': 'CONTACT', 'email': 'unitedstates@bitrialsupport.com', 'phone': '833-602-2368'}], 'facility': 'American Research Corporation at the Texas Liver Institute', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'centralContacts': [{'name': 'Boehringer Ingelheim', 'role': 'CONTACT', 'email': 'clintriage.rdg@boehringer-ingelheim.com', 'phone': '1-800-243-0127'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).\n\nFor more details refer to:\n\nhttps://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}