ESK-001 for Liver Disease

Recruiting at 3 trial locations

Overseen By Central Contact

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Alumis Inc

Disqualifiers: Hypertension, Hypotension, Cardiac disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 1 day

48 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

How does the drug ESK-001 differ from other treatments for liver disease?

ESK-001 may offer a unique approach by potentially targeting liver cells directly, which could improve the drug's effectiveness and reduce side effects on other organs. This targeted delivery is a novel strategy compared to traditional treatments that may not specifically focus on liver cells. ^{1 2 3 4 5}

What is the purpose of this trial?

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.

Research Team

Jorn Drappa, Medical Director

Principal Investigator

Alumis Inc

Eligibility Criteria

This trial is for people with varying degrees of liver health, from normal to severe damage. It's designed to understand how a new drug, ESK-001, behaves in the body depending on liver function.

Inclusion Criteria

Body mass index between 18.0 and 40.0 kg/m2

Exclusion Criteria

Positive hepatitis panel and/or positive human immunodeficiency virus test

My blood pressure or heart rate is not within normal ranges.

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of ESK-001 to assess pharmacokinetics in healthy volunteers and those with varying degrees of hepatic impairment

1 day

Follow-up

Participants are monitored for safety and pharmacokinetic outcomes after receiving the single dose

4 weeks

Treatment Details

Interventions

• ESK-001

Trial Overview The study is testing ESK-001 in different groups based on their liver health. Participants will receive a single dose of the drug, and researchers will track how it's processed by bodies with different levels of liver function.

Participant Groups

Group I: Severe Hepatic Impairment Experimental Treatment 1 Intervention

8 participants with severe hepatic impairment will receive a single dose of ESK-001

Group II: Moderate Hepatic Impairment Experimental Treatment 1 Intervention

8 participants with moderate hepatic impairment will receive a single dose of ESK-001

Group III: Mild Hepatic Impairment Experimental Treatment 1 Intervention

8 participants with mild hepatic impairment will receive a single dose of ESK-001

Group IV: Healthy Volunteer Experimental Treatment 1 Intervention

Up to 24 healthy volunteer participants will receive a single dose of ESK-001

Who Is Running the Clinical Trial?

Alumis Inc

Lead Sponsor

Trials

9

Recruited

4,200+

References

1. England pubmed.ncbi.nlm.nih.gov

The prospects of hepatic drug delivery and gene therapy. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Generation of liver disease-specific induced pluripotent stem cells along with efficient differentiation to functional hepatocyte-like cells. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Liver cell-targeted delivery of therapeutic molecules. [2015]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Disease-corrected hepatocyte-like cells from familial hypercholesterolemia-induced pluripotent stem cells. [2022]

5. China pubmed.ncbi.nlm.nih.gov

Hepatic differentiation from embryonic stem cells in vitro. [2007]