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| Name | Class |
|---|---|
| PRA Health Sciences | INDUSTRY |
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This study is a randomized, double-blind, placebo-controlled study. It will assess the safety, tolerability, and pharmacokinetics of orally administered single and multiple doses of EDP-297 in healthy adult subjects.
The first phase assesses single ascending doses of EDP-297 or placebo in healthy subjects. A "fasted" and "fed" two-part cohort will also assess food effect.
The second phase assesses multiple ascending doses of EDP-297 or placebo for 14-days in healthy subjects.
Each cohort within each phase will enroll a total of 8 subjects who will be randomized to receive EDP-297 or placebo. The cohort assessing food effect will enroll 10 subjects randomized to receive EDP-297 or placebo
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EDP-297 SAD Cohorts | Experimental | EDP-297 Dose 1, Dose 2, Dose 3, Dose 4, Dose 5 and Dose 6 oral solution, once daily in one single administration |
|
| EDP-297 MAD Cohorts | Experimental | EDP-297 Dose 1, Dose 2 and Dose 3 oral solution, once daily for 14 days |
|
| EDP-297 SAD Placebo Cohort | Placebo Comparator | Matching placebo, oral solution, once daily in one single administration |
|
| EDP-297 MAD Placebo Cohort | Placebo Comparator | Matching placebo, oral solution, once daily for 14 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EDP-297 | Drug | EDP-297 Oral solution |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Safety measured by adverse events | Up to 8 Days in SAD Cohorts | |
| Safety measured by adverse events | Up to 21 Days in MAD Cohorts |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax of EDP-297 | Up to 6 Days in SAD Cohorts | |
| Cmax of EDP-297 | Up to 18 Days in MAD Cohorts | |
| AUC of EDP-297 |
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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 |
|---|---|---|---|---|---|---|
| PRA Health Sciences | Groningen | 9728 NZ | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36369848 | Derived | Marotta C, Ahmad A, Luo E, Oosterhaven J, van Marle S, Adda N. EDP-297: A novel, farnesoid X receptor agonist-Results of a phase I study in healthy subjects. Clin Transl Sci. 2023 Feb;16(2):338-351. doi: 10.1111/cts.13453. Epub 2022 Nov 21. |
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| Placebo |
| Drug |
placebo to match EDP-297 |
|
| Up to 6 Days in SAD Cohorts |
| AUC of EDP-297 | Up to 18 Days in MAD Cohorts |