Clinical Trial Details
| Trial ID: | L0542 |
| Source ID: | NCT03187496 |
| Associated Drug: | EDP-305 |
| Title: | A Non-Randomized, Multiple-Dose, Open-Label, Single Sequence Study to Evaluate the Effect of Concomitant Administration of EDP-305 on the Pharmacokinetics and Safety of Midazolam, Caffeine, and Rosuvastatin in Healthy Human Volunteers |
| Acronym: | -- |
| Status: | Not recruiting |
| Study Results: | No Results Available |
| Results: | -- |
| Conditions: | NASH;NASH;NASH;NASH |
| Interventions: | Drug: Midazolam;Drug: Caffeine;Drug: Rosuvastatin;Drug: EDP-305;Drug: Midazolam;Drug: Caffeine;Drug: Rosuvastatin;Drug: EDP-305;Drug: Midazolam;Drug: Caffeine;Drug: Rosuvastatin;Drug: EDP-305;Drug: Midazolam;Drug: Caffeine;Drug: Rosuvastatin;Drug: EDP-305 |
| Outcome Measures: | Cmax of midazolam, caffeine, and rosuvastatin with and without the coadministration of EDP-305.;AUC of midazolam, caffeine, and rosuvastatin with and without the coadministration of EDP-305.;Cmax of midazolam, caffeine, and rosuvastatin with and without the coadministration of EDP-305.;AUC of midazolam, caffeine, and rosuvastatin with and without the coadministration of EDP-305.;Cmax of midazolam, caffeine, and rosuvastatin with and without the coadministration of EDP-305.;AUC of midazolam, caffeine, and rosuvastatin with and without the coadministration of EDP-305.Cmax of 1'-hydroxymidazolam, paraxanthine and N-desmethyl-rosuvastatin with and without the coadministration of EDP-305.;AUC of 1'-hydroxymidazolam, paraxanthine and N-desmethyl-rosuvastatin with and without the coadministration of EDP-305.;Tmax of midazolam, 1'-hydroxymidazolam, caffeine, paraxanthine, rosuvastatin and N-desmethyl-rosuvastatin with and without the coadministration of EDP-305.;t1/2 of midazolam, 1'-hydroxymidazolam, caffeine, paraxanthine, rosuvastatin and N-desmethyl-rosuvastatin with and without the coadministration of EDP-305.;CL/F of midazolam, caffeine and rosuvastatin with and without the coadministration of EDP-305.;Vd/F of midazolam, 1'-hydroxymidazolam, caffeine, paraxanthine, rosuvastatin and N-desmethyl-rosuvastatin with and without the coadministration of EDP-305.;AUC ratios for 1'-hydroxymidazolam/midazolam, paraxanthine/caffeine, and N-desmethyl-rosuvastatin/rosuvastatin.;Safety measured by adverse events, physical exams, vital signs, 12-lead electrocardiograms (ECGs) and clinical lab results (including chemistry, hematology, and urinalysis). |
| Sponsor/Collaborators: | Enanta Pharmaceuticals |
| Gender: | All |
| Age: | 18 Years55 Years |
| Phases: | Phase 1 |
| Enrollment: | 24 |
| Study Type: | Interventional |
| Study Designs: | Intervention model: Single Group Assignment. Primary purpose: Basic Science. Masking: None (Open Label). |
| Start Date: | 01/06/2017 |
| Completion Date: | -- |
| Results First Posted: | -- |
| Last Update Posted: | 16 December 2017 |
| Locations: | United States;United States;United States;United States;United States |
| URL: | https://clinicaltrials.gov/show/NCT03187496 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress | |
|---|---|---|---|---|---|---|---|
| D117 | EDP-305 | Chemical drug | -- | FXR agonist | Enhance lipid metabolism | Under clinical trials | Details |
| D010 | Amoxicillin | Chemical drug | DB01060 | -- | -- | Under clinical trials | Details |
| D094 | Cysteamine | Chemical drug | DB00847 | GSS stimulant | Renal drug | Under clinical trials | Details |
| D095 | Cysteamine bitartrate | Chemical drug | DB00847 | -- | -- | Under clinical trials | Details |
| D223 | Metabolic Cofactor Supplementation | Supplement | -- | -- | -- | Under clinical trials | Details |
| D248 | Obeticholic Acid | Chemical drug | DB05990 | NR1H4 activator; NR1H4 agonist; FXR agonist | Enhance lipid metabolism | Approval rejected | Details |
| D312 | Rosuvastatin | Chemical drug | DB01098 | HMGCR inhibitor | Enhance lipid metabolism | Under clinical trials | Details |