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The purpose of the study is to assess the effect of a therapeutic and supratherapeutic dose of zelicapavir on the corrected cardiac QT interval relative to a placebo and positive control in healthy participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| zelicapavir Dose 1 (therapeutic dose) | Experimental | All participants will receive 4 study interventions. The study interventions will be administered during separate treatment periods starting on Days 1, 9, 17, and 25. |
|
| zelicapavir Dose 2 (supratherapeutic dose) | Experimental | All participants will receive 4 study interventions. The study interventions will be administered during separate treatment periods starting on Days 1, 9, 17, and 25. |
|
| placebo | Placebo Comparator | All participants will receive 4 study interventions. The study interventions will be administered during separate treatment periods starting on Days 1, 9, 17, and 25. |
|
| moxifloxacin | Experimental | All participants will receive 4 study interventions. The study interventions will be administered during separate treatment periods starting on Days 1, 9, 17, and 25. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| zelicapavir (therapeutic dose) | Drug | Subjects will receive zelicapavir (TD) once per treatment period. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time-matched, placebo-corrected change-from-baseline QTc based on the Fridericia correction QTcF (ΔΔQTcF) after TD and SD of Zelicapavir | Up to 24 hours post dose |
| Measure | Description | Time Frame |
|---|---|---|
| Time-matched, placebo-corrected, change-from-baseline non-QT intervals after TD and SD of Zelicapavir | Up to 24 hours post dose | |
| Time-matched, placebo-corrected, change-from-baseline HR after TD and SD of Zelicapavir | Up to 24 hours post dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Enanta Pharmaceuticals, Inc | Enanta Pharmaceuticals, Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ICON | Lenexa | Kansas | 66219 | United States | ||
| ICON Early Phase, LLC |
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| ID | Term |
|---|---|
| D018357 | Respiratory Syncytial Virus Infections |
| ID | Term |
|---|---|
| D018186 | Pneumovirus Infections |
| D018184 | Paramyxoviridae Infections |
| D018701 | Mononegavirales Infections |
| D012327 | RNA Virus Infections |
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| ID | Term |
|---|---|
| C000723099 | EDP-938 |
| D000077266 | Moxifloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
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| zelicapavir (supratherapeutic dose) | Drug | Subjects will receive zelicapavir (SD) once per treatment period. |
|
|
| Placebo | Drug | Subjects will receive zelicapavir matching placebo once per treatment period. |
|
| moxifloxacin | Drug | Subjects will receive moxifloxin once per treatment period. |
|
| Concentration-QTc analysis based on the relationship between plasma concentrations of zelicapavir and ΔΔQTcF after a TD and SD of zelicapavir | Up to 96 hours post dose |
| Cmax of zelicapavir | Up to 96 hours post dose |
| Tmax of zelicapavir | Up to 96 hours post dose |
| t1/2 of zelicapavir | Up to 96 hours post dose |
| Vd/F of zelicapavir | Up to 96 hours post dose |
| CL/F of zelicapavir | Up to 96 hours post dose |
| ΔΔQTcF after moxifloxacin dosing | Up to 24 hours post dose |
| Safety measured by adverse events | Up to Day 33 |
| San Antonio |
| Texas |
| 78290 |
| United States |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |