| Trial ID: | L0337 |
| Source ID: | NCT04146805
|
| Associated Drug: |
BLD-0409
|
| Title: |
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BLD-0409 in Healthy Subjects
|
| Acronym: |
--
|
| Status: |
Completed
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
Chronic Liver Disease|NASH - Nonalcoholic Steatohepatitis
|
| Interventions: |
Drug: BLD-0409|Drug: Control: Placebo
|
| Outcome Measures: |
Incidence of Adverse Events (AEs)|Number of subjects with treatment-related subjects changes in physical examinations|Number of treatment subjects with treatment-related changes in heart rate|Number of treatment subjects with treatment-related changes in systolic & diastolic blood pressure|Number of treatment subjects with treatment-related changes in body temperature|Number of subjects with treatment-related changes in ECG tracings|Number of subjects with treatment-related changes in QTc intervals|Number of subjects with treatment-related changes in hematology clinical laboratory test results.|Number of subjects with treatment-related changes in chemistry clinical laboratory test results.|Number of subjects with treatment-related changes in urinalysis clinical laboratory test results.|Number of subjects with treatment-related changes in serology clinical laboratory test results.|Area under the drug concentration-time curve from time zero to the last measurable concentration (AUClast)|Area under the drug concentration time curve from time 0 to infinity (AUC0-inf)|Maximum observed drug concentration (Cmax)|Time of the maximum drug concentration (tmax)|Apparent terminal elimination rate constant (kel)|Apparent elimination half life (t??)|Apparent oral clearance|Apparent terminal volume of distribution|Amount excreted during each collection interval (Ae(t'-t''))|Total amount of drug excreted unchanged in the urine over the entire period of sample collection|Percentage of dose excreted unchanged during each collection interval (Fe(t' t")) and over the entire period of sample collection|Renal clearance (CLr) for each collection interval and over the entire period of sample collection|Any observed Changes in serum Lysophosphatidic Acid Receptor (LPA) C18:2
|
| Sponsor/Collaborators: |
Blade Therapeutics
|
| Gender: |
All
|
| Age: |
18 Years to 55 Years ?? (Adult)
|
| Phases: |
Phase 1
|
| Enrollment: |
80
|
| Study Type: |
Interventional
|
| Study Designs: |
Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
|
| Start Date: |
January 10, 2020
|
| Completion Date: |
April 12, 2021
|
| Results First Posted: |
--
|
| Last Update Posted: |
June 4, 2021
|
| Locations: |
Scientia Clinical Research, Randwick, New South Wales, Australia
|
| URL: |
https://ClinicalTrials.gov/show/NCT04146805
|
