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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.
This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4) (A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Volunteer | Experimental | Up to 24 healthy volunteer participants will receive a single dose of ESK-001 |
|
| Mild Renal Impairment | Experimental | 8 participants with mild renal impairment will receive a single dose of ESK-001 |
|
| Moderate Renal Impairment | Experimental | 8 participants with moderate renal impairment will receive a single dose of ESK-001 |
|
| Severe Renal Impairment | Experimental | 8 participants with severe Renal impairment will receive a single dose of ESK-001 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ESK-001 | Drug | Single oral dose of ESK-001 in participants from all cohorts |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of clinically significant changes in clinical laboratory values, vital signs, ECGs, and physical examinations | 48 hours |
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Key Inclusion Criteria for All Participants:
Key Inclusion Criteria for Participants with Renal Impairment:
Key Exclusion Criteria for All Participants:
Key Exclusion Criteria for Participants with normal Renal function:
-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.
Key Exclusion Criteria for Participants with Renal Impairment:
- 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.
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| Name | Affiliation | Role |
|---|---|---|
| Jorn Drappa, Medical Director | Alumis Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Advanced Pharma CR | Miami | Florida | 33147 | United States | ||
| Panax Clinical Research |
The Sponsor Alumis Inc. is a clinical-stage pharmaceutical company that has not yet adopted an Individual Participant Data (IPD) sharing plan.
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| Miami Lakes |
| Florida |
| 33014 |
| United States |
| Floridian Clinical Research | Miami Lakes | Florida | 33016 | United States |
| Orlando Clinical Research Center | Orlando | Florida | 32809 | United States |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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