| Trial ID: | L0073 |
| Source ID: | NCT05203367
|
| Associated Drug: |
BAR502
|
| Title: |
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BAR 502 in Healthy Subjects
|
| Acronym: |
--
|
| Status: |
Not yet recruiting
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
Non-Alcoholic Fatty Liver Disease
|
| Interventions: |
Drug: BAR502|Drug: Placebo
|
| Outcome Measures: |
Incidence of Treatment-Emergent Adverse Events|Assessment of physical examination|Assessment of 12-lead electrocardiogram|Change from baseline at each time point of measurement in supine blood pressure (both systolic and diastolic)|Change from baseline at each time point of measurement in pulse rate|Maximum concentration (Cmax)|Time of occurrence of Cmax (Tmax)|Area under the plasma concentration-time curve (AUC) from time zero to last sampling time with quantifiable concentrations (AUC0-t);|AUC extrapolated to infinity|Apparent terminal elimination rate constant (??z); and apparent terminal elimination half-life (t1/2)|Cumulative amount of drug excreted in urine (AmtCUM)|Area under the urine excretion curve (AUR) from time zero to last observed concentration (AURClast)|Maximum rate of urinary excretion (Rmax)|Percentage of drug recovered in urine (REC%)|Time to Rmax (tumax)|Renal clearance (CLR)|Serum concentrations of total bile acids over time up to 24 hours post-dose|Serum concentrations of FGF19 over time up to 24 hours post-dose.|Serum concentrations of C4 over time up to 24 hours post-dose.|Serum concentrations of GLP-1 over time up to 24 hours post-dose.
|
| Sponsor/Collaborators: |
BAR Pharmaceuticals s.r.l.
|
| Gender: |
All
|
| Age: |
18 Years to 55 Years ?? (Adult)
|
| Phases: |
Phase 1
|
| Enrollment: |
32
|
| Study Type: |
Interventional
|
| Study Designs: |
Allocation: Randomized|Intervention Model: Sequential Assignment|Masking: Double (Participant, Investigator)|Primary Purpose: Other
|
| Start Date: |
February 25, 2022
|
| Completion Date: |
April 30, 2022
|
| Results First Posted: |
--
|
| Last Update Posted: |
January 24, 2022
|
| Locations: |
BlueClinical Phase I, Porto, Portugal
|
| URL: |
https://ClinicalTrials.gov/show/NCT05203367
|
