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| Name | Class |
|---|---|
| Pharmaceutical Research Associates | OTHER |
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This randomized, double-blind, placebo-controlled study will assess the safety, tolerability, and pharmacokinetics of single and multiple orally administered doses of EDP-938 in healthy adult subjects
The first phase assesses single ascending doses for EDP-938 (active drug or placebo) in healthy subjects. A "fasted" and "fed" two-part cohort will also assess food effect.
The second phase assesses multiple ascending doses (active drug or placebo) for 7-days in healthy subjects.
Each cohort within each phase will enroll a total of 8 subjects who will be randomized to receive EDP-938 or placebo. The cohort assessing food effect will enroll 10 subjects randomized to receive EDP-938 or placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EDP-938 SAD Cohorts | Experimental | EDP-938 Dose 1, Dose 2, Dose 3, Dose 4, Dose 5, and Dose 6 oral suspension, once daily in one single administration |
|
| EDP-938 MAD Cohorts | Experimental | EDP-938 Dose 1, Dose 2, Dose 3, and Dose 4 oral suspension, once daily for 7 days |
|
| EDP-938 SAD Placebo Cohort | Placebo Comparator | Matching placebo, oral suspension, once daily in one single administration |
|
| EDP-938 MAD Placebo Cohort | Placebo Comparator | Matching placebo, oral suspension, once daily for 7 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EDP-938 | Drug | Subjects will receive either a single dose of EDP-938 on Day 1 only (SAD) or a single dose of EDP-938 starting on Day 1 through Day 7 (MAD). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety measured by adverse events, physical exams, vital signs, 12-lead electrocardiograms (ECGs) and clinical lab results (including chemistry, hematology, and urinalysis). | Up to 8 days |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax of EDP-938 | Up to 5 Days | |
| Cmax of EDP-938 | Up to 11 Days | |
| AUC of EDP-938 |
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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 |
|---|---|---|---|---|---|---|
| Pharmaceutical Research Associates, Inc., | Lenexa | Kansas | 66219 | United States |
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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 |
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| Placebo | Drug | placebo to match EDP-938 |
|
| Up to 5 Days |
| AUC of EDP-938 | Up to 11 Days |
| D014777 | Virus Diseases |
| D007239 | Infections |