CompletedPhase 1

An Investigational Study of ESK-001 in Participants With Normal Renal Function and Participants With Mild, Moderate, and Severe Impaired Renal Function

United States16 participantsStarted 2025-04-23

Plain-language 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 renal impairment.

Who can participate

Age range18 Years – 75 Years

SexALL

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Exclusion criteria

✕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.

What they're measuring

Maximum observed plasma concentration (Cmax)

Timeframe: 48 hours

Incidence of nonserious adverse events (AE), serious adverse events (SAE), and AE leading to discontinuation

Timeframe: 48 hours

Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration [AUC(0-T)]

Timeframe: 48 hours

Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)]

Timeframe: 48 hours

Trial details

NCT IDNCT06962774

SponsorAlumis Inc

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-08-01

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