A Phase 1 interventional study of EDP-297 and Placebo in NASH - Nonalcoholic Steatohepatitis With Liver Fibrosis, sponsored by Enanta Pharmaceuticals, Inc. Completed at 1 site in Netherlands. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-10-29.
Sponsored by Enanta Pharmaceuticals, Inc · Phase 1, Interventional, and Treatment
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
1,451 studies on the registry are indexed under Fatty Liver; 292 are open to participants now.
This study's enrollment of 82 is above the median of 60 across 1,003 interventional studies indexed under Fatty Liver.
Browse Fatty Liver studies →Enanta Pharmaceuticals, Inc is the lead sponsor of 45 studies on the registry; 2 are open to participants now.
Of its 33 completed or terminated interventional studies of FDA-regulated products, 10 (30%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
EDP-297 Dose 1, Dose 2, Dose 3, Dose 4, Dose 5 and Dose 6 oral solution, once daily in one single administration
Drug: EDP-297
EDP-297 Dose 1, Dose 2 and Dose 3 oral solution, once daily for 14 days
Drug: EDP-297
Matching placebo, oral solution, once daily in one single administration
Drug: Placebo
Matching placebo, oral solution, once daily for 14 days
Drug: Placebo
EDP-297 Oral solution
placebo to match EDP-297
Safety measured by adverse events
Time frame: Up to 8 Days in SAD Cohorts
Safety measured by adverse events
Time frame: Up to 21 Days in MAD Cohorts
Cmax of EDP-297
Time frame: Up to 6 Days in SAD Cohorts
Cmax of EDP-297
Time frame: Up to 18 Days in MAD Cohorts
AUC of EDP-297
Time frame: Up to 6 Days in SAD Cohorts
AUC of EDP-297
Time frame: Up to 18 Days in MAD Cohorts
This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
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Enanta Pharmaceuticals, Inc