| Trial ID: | L0344 |
| Source ID: | NCT04142424
|
| Associated Drug: |
AZD2693
|
| Title: |
A Study to Understand the Safety, Tolerability, and Activity of Drug in Body Over a Period of Time of AZD2693, in Subjects of Non-Childbearing Potential in Overweight But Otherwise Healthy Subjects, and Healthy Chinese and Japanese Subjects
|
| Acronym: |
--
|
| Status: |
Completed
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
Metabolic Disorders|Non-alcoholic Steatohepatitis
|
| Interventions: |
Drug: AZD2693|Drug: Placebo
|
| Outcome Measures: |
Number of subjects experiencing adverse events and serious adverse events|Area under the concentration-time curve from time zero extrapolated to infinity (AUC)|Area under the plasma concentration-time curve from time zero to 48 hours after dosing [AUC(0-48h)]|Area under the plasma concentration-time curve from time zero to time of last quantifiable analyte concentration divided by the dose administered (AUClast/D)|Area under the plasma concentration-curve from time zero to the time of last quantifiable analyte concentration (AUClast)|Area under the plasma concentration-time curve from time zero extrapolated to infinity divided by the dose administered (AUC/D)|Maximum observed plasma drug concentration (Cmax) of AZD2693|Observed maximum plasma concentration divided by the dose administered (Cmax/D)|Time to reach maximum observed concentration following drug administration (tmax)|Apparent terminal elimination half-life associated with the terminal slope (??z) of the semi-logarithmic concentration-time curve, estimated as (ln2)/??z (t????z)|Apparent total body clearance of drug from plasma after extravascular administration calculated as Dose/AUC (CL/F)|Apparent volume of distribution for parent drug at terminal phase (extravascular administration), estimated by dividing CL/F by ??z (Vz/F)|Mean residence time (MRT)|Terminal elimination rate constant, estimated by log-linear least-squares regression of the terminal part of the concentration-time curve (??z)|Time delay between drug administration and the first observed concentration in plasma (tlag)|Time of the last quantifiable concentration (tlast)|Cumulative fraction (%) of dose excreted unchanged into the urine from time zero to the last measured time point [fe(0-last)]|Cumulative amount of analyte excreted into the urine from time zero through the last sampling interval [Ae(0-last)]|Renal clearance of drug from plasma, estimated by dividing Ae(0-t) by AUC(0-t) where the 0-t interval is the same for both Ae and AUC [CLR]|Amount of analyte excreted into the urine from time t1 to t2 [Ae(t1-t2)]|Fraction of dose excreted unchanged into the urine from time t1 to t2 [fe(t1-t2)]
|
| Sponsor/Collaborators: |
AstraZeneca|Parexel
|
| Gender: |
All
|
| Age: |
18 Years to 55 Years ?? (Adult)
|
| Phases: |
Phase 1
|
| Enrollment: |
73
|
| Study Type: |
Interventional
|
| Study Designs: |
Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Care Provider, Investigator)|Primary Purpose: Treatment
|
| Start Date: |
October 28, 2019
|
| Completion Date: |
November 12, 2021
|
| Results First Posted: |
--
|
| Last Update Posted: |
November 26, 2021
|
| Locations: |
Research Site, Glendale, California, United States
|
| URL: |
https://ClinicalTrials.gov/show/NCT04142424
|
