| Trial ID: | L0263 |
| Source ID: | NCT03976687
|
| Associated Drug: |
EYP001a
|
| Title: |
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of EYP001a in Healthy Volunteers and Nonalcoholic Steatohepatitis Patients
|
| Acronym: |
--
|
| Status: |
Completed
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
NASH - Nonalcoholic Steatohepatitis|Healthy
|
| Interventions: |
Drug: EYP001a
|
| Outcome Measures: |
Maximum plasma concentration (Cmax) of EYP001a|Time to reach maximum concentration (Tmax) after EYP001a administration|Area under the concentration-time curve (AUC) from time 0 to last measurable concentration (AUC0-10h and AUClast) of EYP001a|Area under the concentration-time curve (AUC) and Maximum plasma concentration (Cmax) ratios|Type and frequencies of Adverse events|Bile acid precursor : C4 (7??hydroxy-4-cholesten-3-one)|Bile acid precursor : Fibroblast growth factor 19 (FGF19)|Total Bile acids (secondary and primary)
|
| Sponsor/Collaborators: |
Enyo Pharma
|
| Gender: |
All
|
| Age: |
18 Years to 75 Years ?? (Adult, Older Adult)
|
| Phases: |
Phase 1
|
| Enrollment: |
16
|
| Study Type: |
Interventional
|
| Study Designs: |
Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
|
| Start Date: |
June 11, 2019
|
| Completion Date: |
May 25, 2020
|
| Results First Posted: |
--
|
| Last Update Posted: |
September 25, 2020
|
| Locations: |
ENYO Pharma clinical site, Randwick, New South Wales, Australia
|
| URL: |
https://ClinicalTrials.gov/show/NCT03976687
|
