NCT06962774

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Apr 2025

Shorter than P25 for phase_1

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 23, 2025

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

April 30, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 8, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

December 10, 2025

Status Verified

December 1, 2025

Enrollment Period

3 months

First QC Date

April 30, 2025

Last Update Submit

December 9, 2025

Conditions

Renal Impairment

Outcome Measures

Primary Outcomes (4)

  • Maximum observed plasma concentration (Cmax)

    48 hours

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

    48 hours

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

    48 hours

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

    48 hours

Secondary Outcomes (1)

  • Number of clinically significant changes in clinical laboratory values, vital signs, ECGs, and physical examinations

    48 hours

Study Arms (4)

Healthy Volunteer

EXPERIMENTAL

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

Drug: ESK-001

Mild Renal Impairment

EXPERIMENTAL

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

Drug: ESK-001

Moderate Renal Impairment

EXPERIMENTAL

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

Drug: ESK-001

Severe Renal Impairment

EXPERIMENTAL

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

Drug: ESK-001

Interventions

ESK-001DRUG

Single oral dose of ESK-001 in participants from all cohorts

Healthy VolunteerMild Renal ImpairmentModerate Renal ImpairmentSevere Renal Impairment

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Body mass index between 18.0 and 40.0 kg/m2
  • Diagnosis of chronic, stable renal function in the 6 months prior to dosing, as determined by the investigator, based on medical history or eGFR, and not requiring dialysis

You may not qualify if:

  • History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy, cholecystectomy, and hernia repair are allowed).
  • 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.
  • \- History of any uncontrolled or unstable hepatic, hematological, gastrointestinal, neurological, endocrine, or psychiatric disorder, as determined by the investigator or designee, within 6 months prior to screening.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Advanced Pharma CR

Miami, Florida, 33147, United States

Location

Panax Clinical Research

Miami Lakes, Florida, 33014, United States

Location

Floridian Clinical Research

Miami Lakes, Florida, 33016, United States

Location

Orlando Clinical Research Center

Orlando, Florida, 32809, United States

Location

MeSH Terms

Conditions

Renal Insufficiency

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Jorn Drappa, Medical Director

    Alumis Inc

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 30, 2025

First Posted

May 8, 2025

Study Start

April 23, 2025

Primary Completion

August 1, 2025

Study Completion

August 1, 2025

Last Updated

December 10, 2025

Record last verified: 2025-12

Locations

US(4)