ESK-001 for Kidney Failure

Recruiting at 3 trial locations

Overseen By Central Contact

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Alumis Inc

Disqualifiers: Metabolic, Hepatic, Psychiatric, 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

Do I need to stop my current medications for the trial?

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

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 renal impairment.

Research Team

Jorn Drappa, Medical Director

Principal Investigator

Alumis Inc

Eligibility Criteria

This trial is for adults with varying levels of kidney function, from normal to severely impaired. It's not clear what specific conditions exclude someone from participating, but typically those with other serious health issues or who are taking conflicting medications might be ineligible.

Inclusion Criteria

Body mass index between 18.0 and 40.0 kg/m2

Exclusion Criteria

I haven't had major stomach or intestinal surgery affecting drug absorption, except for appendectomy, gallbladder removal, or hernia repair.

I have kidney issues but no uncontrolled health problems in the last 6 months.

I do not have any significant health issues apart from my current condition.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single oral dose of ESK-001 to assess pharmacokinetics

1 day

Follow-up

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

4 weeks

Treatment Details

Interventions

• ESK-001

Trial Overview The study is testing ESK-001 in different groups based on their kidney health: healthy volunteers and those with mild, moderate, or severe impairment. The goal is to see how the drug moves through the body (pharmacokinetics) at a single dose across these groups.

Participant Groups

Group I: Severe Renal Impairment Experimental Treatment 1 Intervention

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

Group II: Moderate Renal Impairment Experimental Treatment 1 Intervention

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

Group III: Mild Renal Impairment Experimental Treatment 1 Intervention

8 participants with mild renal 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+