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
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.