RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase 1, Open-label, Single-dose Study to Investigate the Effect of Renal Impairment on the Pharmacokinetics of a Single Oral Dose of ESK-001

Quick Facts

Study Start:2025-05-09
Study Completion:2025-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06962774

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Central Contact
CONTACT
(650) 231-6625
nharada@alumis.com

Principal Investigator

Jorn Drappa, Medical Director
STUDY_DIRECTOR
Alumis Inc

Study Locations (Sites)

Panax Clinical Research
Miami Lakes, Florida, 33014
United States
Floridian Clinical Research
Miami Lakes, Florida, 33016
United States
Advanced Pharma CR
Miami, Florida, 33147
United States
Orlando Clinical Research Center
Orlando, Florida, 32809
United States

Collaborators and Investigators

Sponsor: Alumis Inc

  • Jorn Drappa, Medical Director, STUDY_DIRECTOR, Alumis Inc

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05-09
Study Completion Date2025-12

Study Record Updates

Study Start Date2025-05-09
Study Completion Date2025-12

Terms related to this study

Additional Relevant MeSH Terms

  • Renal Impairment