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This a phase 1, partially blinded, randomized, crossover study to determine the pharmacokinetics (PK) and QT/QTc interval of study drug (ESK-001) in healthy volunteer participants,
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 |
|---|---|---|---|
| Treatment 1: (Therapeutic dose) | Experimental | 1 oral dose of ESK-001 |
|
| Treatment 2: (Supratherapeutic dose) | Experimental | 1 oral dose of ESK-001 |
|
| Treatment 3: ESK-001-matched placebo | Placebo Comparator |
| |
| Treatment 4: (positive control) | Active Comparator | Moxifloxacin 400 mg tablet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ESK-001 | Drug | Single oral dose of ESK-001 in participants |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in placebo-adjusted QTcF (∆∆QTcF) | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in ECG parameter ΔHR | 24 hours | |
| Change from baseline in ECG parameter Δ PR interval | 24 hours | |
| Change from baseline in ECG parameter ΔQRS duration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jorn Drappa, MD, Ph.D. | Alumis Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fortrea CRU | Daytona Beach | Florida | 32117 | United States |
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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| ID | Term |
|---|---|
| D000077266 | Moxifloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
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All subjects will be randomized to 1 of 4 treatment sequences; each subject will receive all 4 treatments. Treatments 1 through 3 will be blinded; Treatment 4 will be given open label. The central ECG laboratory will be blinded to treatment assignment
| Moxifloxacin (400 mg) | Drug | positive control |
|
| Placebo | Drug | ESK-001-matched placebo |
|
| 24 hours |
| Change from baseline in ECG parameter ΔQTc interval | 24 hours |
| Incidence of nonserious adverse events (AE), serious adverse events (SAE), and AE leading to discontinuation | Up to 22 Days |
| Number of clinically significant changes in clinical laboratory values, vital signs, ECGs, and physical examinations | Up to 22 Days |
| Composite of pharmacokinetic (PK) parameter Vz/F for ESK-001 and metabolites | 24 hours |
| Composite of pharmacokinetic (PK) parameter Cmax for ESK-001 and metabolites | 24 hours |
| Composite of pharmacokinetic (PK) parameter tmax for ESK-001 and metabolites | 24 hours |
| Composite of pharmacokinetic (PK) parameter CL/F for ESK-001 and metabolites | 24 hours |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |