Mild Hepatic ImparementPhase 1NCT07850999
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 study testing ABI-6250 in people with Mild Hepatic Imparement, run by Assembly Biosciences at 1 site in New Zealand.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Mild Hepatic Imparement
- What is being tested?
- ABI-6250
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteNew Zealand
- Study dates
- Oct 2026to Apr 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
- Participant has a body mass index (BMI) of 18.0 to 45.0 kg/m2, is a non/ex/light-smoker, and is willing and able to swallow whole tablets without breaking, butting or chewing.
- Renal function, as measured by eGFR calculated using the 2009 CKD-EPI equation >60 mL/min at Screening.
- Female participants must be nonpregnant and have a negative serum pregnancy test at Screening and a negative urine pregnancy test on Day -2.
- Participants must agree to comply with protocol-specified contraceptive requirements.
- Suitable venous access for blood sample collection.
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- Inclusion Criteria for Participants with Mild Hepatic Impairment (Cohort 1):
- Stable mild hepatic impairment designated as Child-Pugh Class A score of 5 to 6 during Screening and Day -2.
- Must meet certain laboratory parameters as Screening.
- Has medical history, clinical lab test results, vital sign measurements and physical examination consistent with stable mild hepatic impairment, as determined by the Investigator.
- On stable medication regiment for at least 14 days before dosing on Day 1.
- Inclusion Criteria for Participants with Normal Hepatic Function (Cohort 2):
- Has stable normal hepatic function as determined at Screening and Day -2.
- 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.
Who cannot join
- Child-Pugh score >6 at Screening.
- Female participant who is currently pregnant or lactating, or is planning to become pregnant during the study through EOS.
- Positive test results for HAV IgM, HBcAb IgM, HBsAg, or HIV 1/2 Ab at Screening.
- 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.
- 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.
- History or presence of a clinically significant psychiatric or neurological disease within 1 year of Screening.
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- Epilepsy or a history of seizures within the last 2 years (with the exception of febrile seizures).
- Current evidence or history of suicidal behavior in the past 2 years.
- 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.
- 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.).
- Participant has a portal shunt.
- 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.
- 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).
- History or evidence of pancreatic injury or pancreatitis within 6 months of Screening.
- 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.
- Any clinically significant illness in the 30 days before Day -2.
- Known hypersensitivity or allergy to ABI-6250 or constituent of the formulation.
- Received any investigational drug within 30 days or 5 half-lives of the study drug (whichever is longer) before Screening.
- 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.
- 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.
- 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.
- 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.
- Participant is unwilling to abstain from alcohol for 48 hours before Admission until discharge from the CRU.
- Participant is unwilling or unable to comply with the lifestyle considerations described in this protocol.
- Exclusion Criteria for Participants With Mild Hepatic Impairment (Cohort 1):
- 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).
- Vital sign abnormality after at least 5 minutes resting in the supine position at Screening, Day -2, Day -1, or predose on Day 1.
- Abnormal standard 12-lead ECG after at least 5 minutes resting in the supine position at Screening, Day -2, or predose on Day 1.
- 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.
- Exclusion Criteria for Participants With Normal Hepatic Function (Cohort 2):
- History or presence of hepatic disease indicated by medical history or abnormal hepatic function.
- 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.
- Abnormal standard 12-lead ECG after at least 5 minutes resting in the supine position at Screening, Day -2, or predose on Day 1.
- 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).
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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
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.
- Conditions
- Mild Hepatic Imparement
- Being tested
- ABI-6250
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABI-6250Drug
Participants will receive ABI-6250 0.5 mg QD over 10 days.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 & 2, ABI-6250 | Experimental | Not described Receives: Drug: ABI-6250 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed Plasma Concentration (Cmax) of ABI-6250.
Measured: From Day 1 to Day 35, at pre-specified timepoints.
Apparent Terminal Elimination Half Life (t 1/2) of ABI-6250.
Measured: From Day 1 to Day 35, at pre-specified timepoints.
Time to Cmax (Tmax) of ABI-6250.
Measured: From Day 1 to Day 35, at pre-specified timepoints.
Area Under the Plasma Concentration-Time Curve (AUC) from time zero to 24 hours postdose (AUC0-24) of ABI-6250 on Days 1 and 10.
Measured: From Day 1 to Day 35, at pre-specified timepoints.
Apparent Systemic Clearance (CL/F) of ABI-6250.
Measured: From Day 1 to Day 35, at pre-specified timepoints.
Apparent Volume of Distribution (Vz/F) of ABI-6250.
Measured: From Day 1 to Day 35, at pre-specified timepoints.
Adverse events (AEs).
Measured: From enrollment to Day 35.
Incidence of Clinically Significant Clinical Laboratory Parameters Abnormality.
Number of participants with at least one clinically significant laboratory parameters abnormality. The following parameters will be measured: Serum Chemistry: ALT, ALB, Alk phos, AST, BUN, Ca, Co2, Cl, Creatinine kinase, eGFR, GGT, Total Cholesterol, Trig, Glucose, LDH, Potassium, Sodium, T. Bili, D. Bili and I. Bili, Total protein. Hematology: HCT, HGB, MPV, Platelet count, RBC count, RBC indices (MCH, MCHC, MCV, RDW), WBC count, WBC differential (BASO, EOS, LYMPH, MONO, NEUT). Urinalysis: UCLA, UBILQL, UCOL, UGLUQ, UKET, UWEST, UNIT, UOCULT, pH, protein, Specific gravity. Coagulation: aPTT, PT, FIB, INR.
Measured: From enrollment to Day 35, at pre-specified timepoints.
Incidence of Clinically Significant Vital Signs Abnormality.
Number of participants with at least one clinically significant vitals abnormality. The following clinical signs will be measured: systolic blood pressure (mmHg), diastolic blood pressure (mmHg), heart rate (beats/min), respiratory rate (breaths/min), and body temperature (C°).
Measured: From enrollment to Day 35, at pre-specified timepoints.
Incidence of Clinically Significant 12-lead Electrocardiogram (ECG) Abnormality.
Number of participants with at least one clinically significant electrocardiogram abnormality. The following standard 12-lead ECG will be recorded: PR interval (msec), QRS duration (msec), QT interval (msec), QTCF interval (msec), heart rate (beats/min), RR (msec), and interpretation.
Measured: From enrollment to Day 35, at pre-specified timepoints.
Incidence of Clinically Significant Physical Examination Abnormality.
Number of participants with at least one clinically significant physical abnormality. A complete physical examination, including at a minimum, assessments of the general appearance, respiratory, cardiovascular, gastrointestinal, musculoskeletal, and dermatological systems, in addition to examinations of the head, eyes, ears, nose, throat, neck, and lymph nodes, as well as height and weight measurement to calculate BMI.
Measured: From enrollment to Day 35, at pre-specified timepoints.
Secondary outcomes (2)
Bile acid levels in plasma.
Measured: From Day 1 to Day 35, at pre-specified timepoints.
Coproporphyrin 1 (CP-1) levels in plasma.
Measured: From Day 1 to Day 35, at pre-specified timepoints.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Hepatic ImparementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assembly Biosciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07850999
- Sponsor's protocol ID
- ABI-6250-102
- Status last verified
- Sep 2026
- First submitted
- 14 Sep 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07850999
- Acronym / sponsor ID
- ABI-6250-102
- Conditions
- Mild Hepatic Imparement
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Assembly BiosciencesIndustry (pharma, biotech, devices)
- Study start
- Oct 2026 (estimated)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 1 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 & 2, ABI-6250 | Experimental | Drug: ABI-6250 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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.
- Participant has a body mass index (BMI) of 18.0 to 45.0 kg/m2, is a non/ex/light-smoker, and is willing and able to swallow whole tablets without breaking, butting or chewing.
- Renal function, as measured by eGFR calculated using the 2009 CKD-EPI equation >60 mL/min at Screening.
- Female participants must be nonpregnant and have a negative serum pregnancy test at Screening and a negative urine pregnancy test on Day -2.
- Participants must agree to comply with protocol-specified contraceptive requirements.
Key exclusion criteria (35 listed)
- Child-Pugh score >6 at Screening.
- Female participant who is currently pregnant or lactating, or is planning to become pregnant during the study through EOS.
- Positive test results for HAV IgM, HBcAb IgM, HBsAg, or HIV 1/2 Ab at Screening.
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ABI-6250Participants will receive ABI-6250 0.5 mg QD over 10 days. | Drug | Cohort 1 & 2, ABI-6250 |
Primary outcome
Maximum Observed Plasma Concentration (Cmax) of ABI-6250.
Time frame: From Day 1 to Day 35, at pre-specified timepoints.
Apparent Terminal Elimination Half Life (t 1/2) of ABI-6250.
Time frame: From Day 1 to Day 35, at pre-specified timepoints.
Time to Cmax (Tmax) of ABI-6250.
Time frame: From Day 1 to Day 35, at pre-specified timepoints.
Area Under the Plasma Concentration-Time Curve (AUC) from time zero to 24 hours postdose (AUC0-24) of ABI-6250 on Days 1 and 10.
Time frame: From Day 1 to Day 35, at pre-specified timepoints.
Apparent Systemic Clearance (CL/F) of ABI-6250.
Time frame: From Day 1 to Day 35, at pre-specified timepoints.
Apparent Volume of Distribution (Vz/F) of ABI-6250.
Time frame: From Day 1 to Day 35, at pre-specified timepoints.
Adverse events (AEs).
Time frame: From enrollment to Day 35.
Incidence of Clinically Significant Clinical Laboratory Parameters Abnormality.
Time frame: From enrollment to Day 35, at pre-specified timepoints.
Number of participants with at least one clinically significant laboratory parameters abnormality. The following parameters will be measured: Serum Chemistry: ALT, ALB, Alk phos, AST, BUN, Ca, Co2, Cl, Creatinine kinase, eGFR, GGT, Total Cholesterol, Trig, Glucose, LDH, Potassium, Sodium, T. Bili, D. Bili and I. Bili, Total protein. Hematology: HCT, HGB, MPV, Platelet count, RBC count, RBC indices (MCH, MCHC, MCV, RDW), WBC count, WBC differential (BASO, EOS, LYMPH, MONO, NEUT). Urinalysis: UCLA, UBILQL, UCOL, UGLUQ, UKET, UWEST, UNIT, UOCULT, pH, protein, Specific gravity. Coagulation: aPTT, PT, FIB, INR.
Incidence of Clinically Significant Vital Signs Abnormality.
Time frame: From enrollment to Day 35, at pre-specified timepoints.
Number of participants with at least one clinically significant vitals abnormality. The following clinical signs will be measured: systolic blood pressure (mmHg), diastolic blood pressure (mmHg), heart rate (beats/min), respiratory rate (breaths/min), and body temperature (C°).
Incidence of Clinically Significant 12-lead Electrocardiogram (ECG) Abnormality.
Time frame: From enrollment to Day 35, at pre-specified timepoints.
Number of participants with at least one clinically significant electrocardiogram abnormality. The following standard 12-lead ECG will be recorded: PR interval (msec), QRS duration (msec), QT interval (msec), QTCF interval (msec), heart rate (beats/min), RR (msec), and interpretation.
Incidence of Clinically Significant Physical Examination Abnormality.
Time frame: From enrollment to Day 35, at pre-specified timepoints.
Number of participants with at least one clinically significant physical abnormality. A complete physical examination, including at a minimum, assessments of the general appearance, respiratory, cardiovascular, gastrointestinal, musculoskeletal, and dermatological systems, in addition to examinations of the head, eyes, ears, nose, throat, neck, and lymph nodes, as well as height and weight measurement to calculate BMI.
2 secondary outcomes
Bile acid levels in plasma.
Time frame: From Day 1 to Day 35, at pre-specified timepoints.
Coproporphyrin 1 (CP-1) levels in plasma.
Time frame: From Day 1 to Day 35, at pre-specified timepoints.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ABI-6250 in people with Mild Hepatic Imparement, run by Assembly Biosciences at 1 site in New Zealand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Assembly Biosciences (833-509-4583, clinicaltrials@assemblybio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Observed Plasma Concentration (Cmax) of ABI-6250. (time frame: From Day 1 to Day 35, at pre-specified timepoints.). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.