Hepatic InsufficiencyPhase 1NCT07853040
A Study to Evaluate the Pharmacokinetics and Safety of INCB161734 in Participants With Hepatic Impairment
A Phase 1 study testing INCB161734 in people with Hepatic Insufficiency and Liver Diseases, run by Incyte Corporation.
Trial summary
This study is conducted to evaluate the pharmacokinetics and safety of INCB161734 in participants with hepatic impairment. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hepatic Insufficiency, Liver Diseases
- What is being tested?
- INCB161734
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- 13 Oct 2026to 31 Mar 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability to comprehend and willingness to sign a written ICF for the study.
- Age 18 to 80 years (inclusive) at the time of signing the ICF.
- Moderate or severe hepatic impairment based on Child-Pugh score.
- Medical findings consistent with the degree of hepatic dysfunction, determined by medical history, physical examination, vital sign measurements, 12-lead ECGs, and clinical laboratory examinations at screening and check-in.
- BMI of 18.0 to 44.0 kg/m2 (inclusive) at screening.
- Ability to swallow and retain oral tablets.
- Willingness to avoid pregnancy or fathering children.
Who cannot join
- In the opinion of the investigator, history of uncontrolled or unstable cardiovascular, respiratory, renal, GI, endocrine, hematopoietic, psychiatric, and/or neurological disease within 6 months before screening or evidence of rapidly deteriorating hepatic function.
- History or current diagnosis of uncontrolled or significant cardiac disease indicating significant risk of safety for participation in the study.
- Current, functioning organ transplant or on the national transplant list and expected to receive a transplant within 3 months.
- History of an autoimmune disease diagnosis (eg, myasthenia gravis).
- History of malignancy within 5 years before screening, with the exception of cured basal cell carcinoma, squamous cell carcinoma of the skin, ductal carcinoma in situ, or Gleason 6 prostate cancer.
- History of clinically significant GI disease or surgery (cholecystectomy and appendectomy are allowed) that could impact the absorption of study drug.
Show all 33Show fewer
- Severe ascites (ascites requiring paracentesis more than twice every 4 weeks) or encephalopathy ≥ Grade 2 (precludes them from understanding and signing an ICF).
- Any major surgery within 4 weeks before screening.
- Donation of blood within 4 weeks before screening (within 2 weeks for plasma only).
- Blood transfusion within 4 weeks before check-in (Day -1).
- Current or recent history (within 30 days before screening) of a clinically significant bacterial, fungal, parasitic, or mycobacterial infection, or currently receiving systemic antibiotics or current clinically significant viral infection at screening or check-in (Day -1).
- History of alcoholism within 3 months before screening.
- Positive breath, urine, or blood test for ethanol or positive serum or urine screen for drugs of abuse that is not otherwise explained by permitted concomitant medications.
- Current treatment or treatment within 30 days or 5 half-lives (whichever is longer) before study drug administration with another investigational medication or current enrollment in another investigational drug study.
- Current treatment or treatment within 15 days or 5 half-lives (whichever is longer) before study drug administration with an inducer or inhibitor of CYP3A4, P-gp, or BCRP.
- Use of prescription drugs (including hormonal contraceptives) within 14 days before study drug administration or nonprescription medications/products (including megadose vitamins, minerals, and phytotherapeutic, herbal, or plant-derived preparations as well as pre/probiotics) within 7 days before study drug administration.
- Note 1: Occasional acetaminophen, standard-dose ibuprofen, and standard-dose vitamins are permitted.
- Note 2: Established therapy for hepatic disease, or the treatment of associated disorders, that has been stable for at least 7 days prior to study drug administration is allowed if approved by the medical monitor and investigator.
- Consumption of alcohol within 1 month before screening.
- Consumption of caffeine-containing foods and beverages within 3 days before check-in (Day -1).
- Consumption of Seville oranges, grapefruits, pomelos, exotic citrus fruits, grapefruit hybrids, or fruit juices within 7 days before the first dose of study drug.
- Current use of prohibited medication.
- Receipt of live (including attenuated) vaccines or anticipation of need for such a vaccine during the study. (Note: Non-live or inactivated vaccines allowed up to 2 weeks before study drug administration.).
- Known hypersensitivity or severe reaction to INCB161734 or excipients of INCB161734.
- History of any significant drug allergy (such as anaphylaxis or hepatotoxicity) deemed clinically relevant by the investigator.
- Inability to undergo venipuncture or tolerate venous access.
- Any condition that would, in the investigator's judgment, interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of the study data.
- Currently smoke > 10 cigarettes per day, or equivalent use of other tobacco- or nicotine-containing products, and are unwilling to refrain from tobacco or nicotine use on treatment days and abide by CRU restrictions.
- Women who are pregnant or breastfeeding.
- New medication requirement or an increase in dose for hepatic encephalopathy within 3 months prior to check-in.
- Current portal systemic shunt.
- Esophageal banding within 3 months prior to check-in or required any other treatment for GI bleeding within 6 months prior to check-in. Hemorrhoidal banding is permitted.
- Other protocol-defined Inclusion/Exclusion Criteria may apply.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase 1, Open-Label Study to Evaluate the Pharmacokinetics and Safety of INCB161734 in Participants With Hepatic Impairment
This study is conducted to evaluate the pharmacokinetics and safety of INCB161734 in participants with hepatic impairment.
- Conditions
- Hepatic Insufficiency, Liver Diseases
- Being tested
- INCB161734
- Keywords
- hepatic impairment, liver impairment (moderate and severe)
- Medical subject headings
- Hepatic Insufficiency, Liver Diseases, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INCB161734Drug
single dose administered orally
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Moderate hepatic impairment | Experimental | Participants with moderate hepatic impairment will be enrolled in Cohort 1. Receives: Drug: INCB161734 |
| Cohort 2: Severe hepatic impairment | Experimental | Participants with severe hepatic impairment will be enrolled in Cohort 2. Receives: Drug: INCB161734 |
What is being measured
The primary outcome is the main question the study is designed to answer.
PK for plasma INCB161734: Cmax
Defined as the maximum plasma concentration.
Measured: Up to approximately 1.5 months
PK for plasma INCB161734: AUClast
Defined as the area under the concentration-time curve from time zero to time of the last quantifiable concentration.
Measured: Up to approximately 1.5 months
PK for plasma INCB161734: AUCinf
Defined as the area under concentration-time curve from time zero extrapolated to infinity.
Measured: Up to approximately 1.5 months
Secondary outcomes (7)
Number of Treatment-Emergent Adverse Events (TEAEs)
Adverse events reported for the first time or worsening of a pre-existing event, occurring after first dose of study drug.
Measured: Up to approximately 1.5 months and 15 days
PK for plasma INCB161734: Tmax
Defined as the time to maximum concentration.
Measured: Up to approximately 1.5 months
PK for plasma INCB161734: t½
Defined as the terminal-phase half-life.
Measured: Up to approximately 1.5 months
PK for plasma INCB161734: Tlast
Defined as the time at which the last quantifiable concentration is observed.
Measured: Up to approximately 1.5 months
PK for plasma INCB161734: CL/F
Defined as the apparent clearance.
Measured: Up to approximately 1.5 months
PK for plasma INCB161734: Vz/F
Defined as the apparent volume of distribution.
Measured: Up to approximately 1.5 months
PK for plasma INCB161734: AUCextrap%
Defined as the percentage of area under the plasma concentration-time curve from time zero extrapolated to infinity obtained by forward extrapolation.
Measured: Up to approximately 1.5 months
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 start13 Oct 2026 (estimated)
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic InsufficiencyStudies of the same condition, open and under way.
- More trials run by Incyte CorporationThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Incyte Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Incyte Medical Monitor, Study director, Incyte Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07853040
- Sponsor's protocol ID
- INCB161734-105
- Status last verified
- Sep 2026
- First submitted
- 25 Sep 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label Study to Evaluate the Pharmacokinetics and Safety of INCB161734 in Participants With Hepatic Impairment
- ClinicalTrials.gov ID
- NCT07853040
- Acronym / sponsor ID
- INCB161734-105
- Conditions
- Hepatic Insufficiency, Liver Diseases
- Keywords
- hepatic impairment, liver impairment (moderate and severe)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Incyte CorporationIndustry (pharma, biotech, devices)
- Study start
- 13 Oct 2026 (estimated)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 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 conducted to evaluate the pharmacokinetics and safety of INCB161734 in participants with hepatic impairment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Moderate hepatic impairment | Experimental | Drug: INCB161734Participants with moderate hepatic impairment will be enrolled in Cohort 1. |
| Cohort 2: Severe hepatic impairment | Experimental | Drug: INCB161734Participants with severe hepatic impairment will be enrolled in Cohort 2. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Ability to comprehend and willingness to sign a written ICF for the study.
- Age 18 to 80 years (inclusive) at the time of signing the ICF.
- Moderate or severe hepatic impairment based on Child-Pugh score.
- Medical findings consistent with the degree of hepatic dysfunction, determined by medical history, physical examination, vital sign measurements, 12-lead ECGs, and clinical laboratory examinations at screening and check-in.
- BMI of 18.0 to 44.0 kg/m2 (inclusive) at screening.
Key exclusion criteria (33 listed)
- In the opinion of the investigator, history of uncontrolled or unstable cardiovascular, respiratory, renal, GI, endocrine, hematopoietic, psychiatric, and/or neurological disease within 6 months before screening or evidence of rapidly deteriorating hepatic function.
- History or current diagnosis of uncontrolled or significant cardiac disease indicating significant risk of safety for participation in the study.
- Current, functioning organ transplant or on the national transplant list and expected to receive a transplant within 3 months.
- History of an autoimmune disease diagnosis (eg, myasthenia gravis).
- History of malignancy within 5 years before screening, with the exception of cured basal cell carcinoma, squamous cell carcinoma of the skin, ductal carcinoma in situ, or Gleason 6 prostate cancer.
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 |
|---|---|---|
| INCB161734single dose administered orally | Drug | Cohort 1: Moderate hepatic impairment, Cohort 2: Severe hepatic impairment |
Primary outcome
PK for plasma INCB161734: Cmax
Time frame: Up to approximately 1.5 months
Defined as the maximum plasma concentration.
PK for plasma INCB161734: AUClast
Time frame: Up to approximately 1.5 months
Defined as the area under the concentration-time curve from time zero to time of the last quantifiable concentration.
PK for plasma INCB161734: AUCinf
Time frame: Up to approximately 1.5 months
Defined as the area under concentration-time curve from time zero extrapolated to infinity.
7 secondary outcomes
Number of Treatment-Emergent Adverse Events (TEAEs)
Time frame: Up to approximately 1.5 months and 15 days
PK for plasma INCB161734: Tmax
Time frame: Up to approximately 1.5 months
PK for plasma INCB161734: t½
Time frame: Up to approximately 1.5 months
PK for plasma INCB161734: Tlast
Time frame: Up to approximately 1.5 months
PK for plasma INCB161734: CL/F
Time frame: Up to approximately 1.5 months
PK for plasma INCB161734: Vz/F
Time frame: Up to approximately 1.5 months
PK for plasma INCB161734: AUCextrap%
Time frame: Up to approximately 1.5 months
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 1 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Hepatic Insufficiency
Not yet recruiting
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
Acute-on-Chronic Liver Failure (ACLF)
Not yet recruiting
Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
Not yet recruitingPhase 1
A Study to Assess the Pharmacokinetics and Safety of Revumenib in Participants With Advanced Cancer and Hepatic or Renal Impairment
Relapsed/Refractory (R/R) Hematologic Malignancies, Acute Leukemia
Active, not recruiting
LiverPAL: A Trial of Inpatient Palliative Care for Patients With Advanced Liver Disease
Liver Disease Chronic, End Stage Liver DIsease
RecruitingObservational study
Establishing a Reference Framework for Outcomes After Machine-Preserved Liver Transplantation in Europe
End-stage Liver Disease (ESLD), Acute Liver Failure
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.
Incyte Medical Monitor study director
Incyte Corporation
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing INCB161734 in people with Hepatic Insufficiency and Liver Diseases, run by Incyte Corporation.
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 7 inclusion and 33 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 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Incyte Corporation Call Center (US) (1.855.463.3463, medinfo@incyte.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PK for plasma INCB161734: Cmax (time frame: Up to approximately 1.5 months). The study lists 3 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 1 Oct 2026.