[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"mild-hepatic-imparement\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:mild-hepatic-imparement":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":5},"100658532","phase-1-a-study-to-assess-the-safety-tolerability-and-pharmacokinetics-of-abi-6250-in-participants-with-mild-hepatic-impairment-compared-with-participants-with-normal-hepatic-function-100658532",false,"NCT07850999","A Study to Assess the Safety, Tolerability and Pharmacokinetics of ABI-6250 in Participants With Mild Hepatic Impairment Compared With Participants With Normal Hepatic Function","A Phase 1, Open-Label, Multiple-Dose Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of ABI-6250 in Participants With Mild Hepatic Impairment Compared With Participants With Normal Hepatic Function","Inclusion Criteria (All Participants):\n\n* Participant is willing and able to provide written informed consent, is available for the entire study period, is able to understand and comply with study requirements, procedures and restrictions, able to remain at the clinical research unit (CRU) for the required study duration and return to the CRU for outpatient assessments.\n* Participant has a body mass index (BMI) of 18.0 to 45.0 kg\u002Fm2, is a non\u002Fex\u002Flight-smoker, and is willing and able to swallow whole tablets without breaking, butting or chewing.\n* Renal function, as measured by eGFR calculated using the 2009 CKD-EPI equation \\>60 mL\u002Fmin at Screening.\n* Female participants must be nonpregnant and have a negative serum pregnancy test at Screening and a negative urine pregnancy test on Day -2.\n* Participants must agree to comply with protocol-specified contraceptive requirements.\n* Suitable venous access for blood sample collection.\n\nInclusion Criteria for Participants with Mild Hepatic Impairment (Cohort 1):\n\n* Stable mild hepatic impairment designated as Child-Pugh Class A score of 5 to 6 during Screening and Day -2.\n* Must meet certain laboratory parameters as Screening.\n* Has medical history, clinical lab test results, vital sign measurements and physical examination consistent with stable mild hepatic impairment, as determined by the Investigator.\n* On stable medication regiment for at least 14 days before dosing on Day 1.\n\nInclusion Criteria for Participants with Normal Hepatic Function (Cohort 2):\n\n* Has stable normal hepatic function as determined at Screening and Day -2.\n* Medically healthy, as determined by no clinically significant finding from medical history, clinical lab test results, vital sign measurements, 12-lead ECG results, and physical examination results.\n\nExclusion Criteria (All Participants):\n\n* Child-Pugh score \\>6 at Screening.\n* Female participant who is currently pregnant or lactating, or is planning to become pregnant during the study through EOS.\n* Positive test results for HAV IgM, HBcAb IgM, HBsAg, or HIV 1\u002F2 Ab at Screening.\n* Positive screen for drugs or alcohol (listed in Table 5) at Screening or on Day -2, with the exception of prescription medication (including THC) as determined by the Investigator to be therapeutic.\n* Changes in permitted concomitant medication regimen (defined as starting a new medication\\[s\\] or a change in the dosage or frequency of the concomitant medication\\[s\\] within 14 days or 5 half-lives \\[whichever is longer\\]) before dosing on Day 1.\n* History or presence of a clinically significant psychiatric or neurological disease within 1 year of Screening.\n* Epilepsy or a history of seizures within the last 2 years (with the exception of febrile seizures).\n* Current evidence or history of suicidal behavior in the past 2 years.\n* History or presence of uncontrolled cardiac diseases including conduction and structural abnormalities, which may place the participant at increased risk as determined by the Investigator.\n* Impairment of GI function or disease that may significantly alter the absorption of ABI-6250 or may predispose the participant to an increased risk of GI toxicity (eg, inflammatory bowel disease, celiac disease, prior gastrectomy, gastric bypass, small bowel resection, etc.).\n* Participant has a portal shunt.\n* Clinically significant history or evidence of pulmonary, neurologic, psychiatric, cardiovascular, hematologic, dermatologic, immunologic, or metabolic disease; or any other condition or organ system disease that in the opinion of the Investigator would jeopardize the safety of the participant or impact validity of study results.\n* Has a malignancy, a history of malignancy, or has received treatment for a malignancy at any time, with the exception of resected and cured basal cell carcinoma or squamous cell carcinoma of the skin (\\>1 year).\n* History or evidence of pancreatic injury or pancreatitis within 6 months of Screening.\n* Ongoing history of any medical condition other than mild hepatic impairment as defined by inclusion criteria #12, #13, #14 #15, and #16 that in the opinion of the Investigator would increase the risk to the participant if enrolled in the study or make the participant unsuitable for the study.\n* Any clinically significant illness in the 30 days before Day -2.\n* Known hypersensitivity or allergy to ABI-6250 or constituent of the formulation.\n* Received any investigational drug within 30 days or 5 half-lives of the study drug (whichever is longer) before Screening.\n* Participant has had an immunization within 30 days of Screening. Coronavirus disease 2019 vaccine is allowed if the vaccination took place at least 7 days before Screening.\n* Donation or significant loss of blood or blood products of 500 mL or more within 56 days before Screening, or donation or loss of plasma within 7 days before Screening, or plans to donate blood or plasma through EOS.\n* Participant is unwilling to abstain from consumption of grapefruit, pomelo, or Seville orange whole fruits or juices for 7 days before Day 1 and through EOS.\n* Participant is unwilling to abstain from ingesting caffeine- or xanthine-containing products (eg, coffee, tea, cola drinks, and chocolate) for 24 hours before Admission until discharge from the CRU.\n* Participant is unwilling to abstain from alcohol for 48 hours before Admission until discharge from the CRU.\n* Participant is unwilling or unable to comply with the lifestyle considerations described in this protocol.\n\nExclusion Criteria for Participants With Mild Hepatic Impairment (Cohort 1):\n\n* Any finding that, in the judgment of the Investigator, is a clinically significant laboratory abnormality unrelated to the participant's hepatic impairment, including serum chemistry, hematology, coagulation, and urinalysis test results (abnormal test may be repeated for confirmation).\n* Vital sign abnormality after at least 5 minutes resting in the supine position at Screening, Day -2, Day -1, or predose on Day 1.\n* Abnormal standard 12-lead ECG after at least 5 minutes resting in the supine position at Screening, Day -2, or predose on Day 1.\n* Positive test for drugs of abuse, including alcohol at Screening or Admission (Day -2), with the exception of medications under prescription and verified by the Investigator as used for therapeutic management.\n\nExclusion Criteria for Participants With Normal Hepatic Function (Cohort 2):\n\n* History or presence of hepatic disease indicated by medical history or abnormal hepatic function.\n* Abnormal vital sign measurements after at least 5 minutes resting in the supine position at Screening, Day -2, Day -1, or predose on Day 1.\n* Abnormal standard 12-lead ECG after at least 5 minutes resting in the supine position at Screening, Day -2, or predose on Day 1.\n* Any finding that, in the judgment of the Investigator, is a clinically significant laboratory abnormality, including serum chemistry, hematology, coagulation, and urinalysis test results (abnormal test results may be repeated for confirmation).\n* Use of any prescription medication or OTC medication, including multivitamins, dietary and herbal supplements within 14 days or 5 half-lives, whichever is longer, before dosing on Day 1 and until the EOS.",true,"ALL","18 Years","80 Years",{"count":21,"type":22},20,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","This study is designed to assess the safety, tolerability and pharmacokinetics of ABI-6250 in participants with mild hepatic impairment compared with participants with normal hepatic function.",[28],"Mild Hepatic Imparement","NOT_YET_RECRUITING","2026-09-24",{"date":32,"type":33},"2026-10-01","ACTUAL",{"date":35,"type":22},"2026-10",{"date":37,"type":22},"2027-04",{"name":39,"class":40},"Assembly Biosciences","INDUSTRY"]