Hepatic ImpairmentPhase 1NCT06952634
An Investigational Study of ESK-001 in Participants With Normal Liver Function and Participants With Mild, Moderate, and Severe Liver Damage
A Phase 1 study testing envudeucitinib in people with Hepatic Impairment, run by Alumis Inc at 4 sites in United States.
Trial summary
This a phase 1, open label, single dose, parallel cohort study to determine the pharmacokinetics (PK) of study drug (ESK-001) in healthy volunteer participants, and participants with mild, moderate, and severe hepatic impairment. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatic Impairment
- What is being tested?
- envudeucitinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 4 sitesUnited States
- Study dates
- 29 Apr 2025to 24 Mar 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Body mass index between 18.0 and 40.0 kg/m2
- Key Inclusion Criteria for Participants with Hepatic Impairment:
- Diagnosis of chronic (> 6 months), stable hepatic impairment with no clinically significant changes within 30 days prior to dosing, as determined by medical history
Who cannot join
- Uncontrolled treated/untreated hypertension (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 105 mmHg), or uncontrolled treated/untreated hypotension (systolic blood pressure < 90 mmHg and/or diastolic blood pressure < 50 mmHg), or resting pulse rate < 45 or > 100 bpm. Measurements may be repeated once in order to determine eligibility
- Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the investigator or designee.
- Positive hepatitis panel and/or positive human immunodeficiency virus test.
- Key Exclusion Criteria for Participants with Hepatic Impairment:
- History of any uncontrolled or unstable renal, hematological, gastrointestinal, neurological, endocrine, or psychiatric disorder, as determined by the investigator or designee, within 6 months prior to screening.
- History or current diagnosis of uncontrolled or significant cardiac disease indicative of a significant risk of safety for participation in the study.
- Liver function tests outside the appropriate reference ranges that are not consistent with hepatic dysfunction, as determined by the investigator or designee.
- QTcF > 480 ms for males or > 490 ms for females at screening or check-in, as confirmed from the mean of the original value and 2 repeats.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Alliance for Multispecialty Research
Knoxville, Tennessee, 37920
Orange County Research Center
Lake Forest, California, 92630
Panax Clinical Research
Miami Lakes, Florida, 33104
Orlando Clinical Research Center
Orlando, Florida, 32809
About this study
Official title: A Phase 1, Open Label, Single Dose Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics of ESK001
This a phase 1, open label, single dose, parallel cohort study to determine the pharmacokinetics (PK) of study drug (ESK-001) in healthy volunteer participants, and participants with mild, moderate, and severe hepatic impairment.
Read the detailed description
This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.)
- Conditions
- Hepatic Impairment
- Being tested
- envudeucitinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
envudeucitinibDrug
Single oral dose of ESK-001 in participants from all cohorts
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteer | Experimental | Up to 24 healthy volunteer participants will receive a single dose of ESK-001 Receives: Drug: envudeucitinib |
| Mild Hepatic Impairment | Experimental | 8 participants with mild hepatic impairment will receive a single dose of ESK-001 Receives: Drug: envudeucitinib |
| Moderate Hepatic Impairment | Experimental | 8 participants with moderate hepatic impairment will receive a single dose of ESK-001 Receives: Drug: envudeucitinib |
| Severe Hepatic Impairment | Experimental | 8 participants with severe hepatic impairment will receive a single dose of ESK-001 Receives: Drug: envudeucitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed plasma concentration (Cmax)
Measured: 48 hours
Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration [AUC(0-T)]
Measured: 48 hours
Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)]
Measured: 48 hours
Secondary outcomes (2)
Incidence of nonserious adverse events (AE), serious adverse events (SAE), and AE leading to discontinuation
Measured: 48 hours
Number of clinically significant changes in clinical laboratory values, vital signs, ECGs, and physical examinations
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2025
- Study start29 Apr 2025
- Primary completion24 Mar 2026
- Study completion24 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic ImpairmentStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alumis Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jorn Drappa, Medical Director, Study director, Alumis Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06952634
- Sponsor's protocol ID
- ESK-001-022
- Status last verified
- May 2026
- First submitted
- 22 Apr 2025
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The Sponsor Alumis Inc. is a clinical-stage pharmaceutical company that has not yet adopted an Individual Participant Data (IPD) sharing plan.
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open Label, Single Dose Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics of ESK001
- ClinicalTrials.gov ID
- NCT06952634
- Acronym / sponsor ID
- ESK-001-022
- Conditions
- Hepatic Impairment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Alumis IncIndustry (pharma, biotech, devices)
- Study start
- 29 Apr 2025 (actual)
- Primary completion
- 24 Mar 2026 (actual)
- Study completion
- 24 Mar 2026 (actual)
- First posted
- 1 May 2025 (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 a phase 1, open label, single dose, parallel cohort study to determine the pharmacokinetics (PK) of study drug (ESK-001) in healthy volunteer participants, and participants with mild, moderate, and severe hepatic impairment.
Detailed description
This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.)
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteer | Experimental | Drug: envudeucitinibUp to 24 healthy volunteer participants will receive a single dose of ESK-001 |
| Mild Hepatic Impairment | Experimental | Drug: envudeucitinib8 participants with mild hepatic impairment will receive a single dose of ESK-001 |
| Moderate Hepatic Impairment | Experimental | Drug: envudeucitinib8 participants with moderate hepatic impairment will receive a single dose of ESK-001 |
| Severe Hepatic Impairment | Experimental | Drug: envudeucitinib8 participants with severe hepatic impairment will receive a single dose of ESK-001 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Body mass index between 18.0 and 40.0 kg/m2
- Diagnosis of chronic (> 6 months), stable hepatic impairment with no clinically significant changes within 30 days prior to dosing, as determined by medical history
Key exclusion criteria (8 listed)
- Uncontrolled treated/untreated hypertension (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 105 mmHg), or uncontrolled treated/untreated hypotension (systolic blood pressure < 90 mmHg and/or diastolic blood pressure < 50 mmHg), or resting pulse rate < 45 or > 100 bpm. Measurements may be repeated once in order to determine eligibility
- Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the investigator or designee.
- Positive hepatitis panel and/or positive human immunodeficiency virus test.
- History of any uncontrolled or unstable renal, hematological, gastrointestinal, neurological, endocrine, or psychiatric disorder, as determined by the investigator or designee, within 6 months prior to screening.
- History or current diagnosis of uncontrolled or significant cardiac disease indicative of a significant risk of safety for participation in the study.
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 |
|---|---|---|
| envudeucitinibSingle oral dose of ESK-001 in participants from all cohorts | Drug | Healthy Volunteer, Mild Hepatic Impairment, Moderate Hepatic Impairment, Severe Hepatic Impairment |
Primary outcome
Maximum observed plasma concentration (Cmax)
Time frame: 48 hours
Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration [AUC(0-T)]
Time frame: 48 hours
Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)]
Time frame: 48 hours
2 secondary outcomes
Incidence of nonserious adverse events (AE), serious adverse events (SAE), and AE leading to discontinuation
Time frame: 48 hours
Number of clinically significant changes in clinical laboratory values, vital signs, ECGs, and physical examinations
Time frame: 48 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Individual participant dataSharing planned: Undecided. The Sponsor Alumis Inc. is a clinical-stage pharmaceutical company that has not yet adopted an Individual Participant Data (IPD) sharing plan.
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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. This study is not recruiting at the moment.
Jorn Drappa, Medical Director study director
Alumis Inc
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing envudeucitinib in people with Hepatic Impairment, run by Alumis Inc at 4 sites in United States.
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 3 inclusion and 8 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: finished, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum observed plasma concentration (Cmax) (time frame: 48 hours). 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 12 May 2026.