| Trial ID: | L0232 |
| Source ID: | NCT04483947
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| Associated Drug: |
AZD2693
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| Title: |
A Phase 1, Double Blind, Randomised, Placebo-Controlled, Multi-centre, Multiple Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD2693 in Patients With Non-alcoholic Steatohepatitis (NASH) With Fibrosis S
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| Acronym: |
--
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| Status: |
Recruiting
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| Study Results: |
No Results Available
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| Results: |
--
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| Conditions: |
Non-alcoholic Steatohepatitis (NASH)
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| Interventions: |
Drug: AZD2693;Other: Placebo
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| Outcome Measures: |
Number of participants with adverse eventsAbsolute change from baseline to Week 8 and Week 12 in liver fat content (LFC);Percent change from baseline to Week 8 and Week 12 in liver fat content (LFC);Absolute change from baseline in Alanine Aminotransferase;Percent change from baseline in Alanine Aminotransferase;Absolute change from baseline in Aspartate Aminotransferase;Percent change from baseline in Aspartate Aminotransferase;Absolute change from baseline in Gamma Glutamyl Transferase;Percent change from baseline in Gamma Glutamyl Transferase;Absolute change from baseline in Enhanced Liver Fibrosis (ELF) score;Percent change from baseline in ELF score;Absolute change from baseline in plasma cholesteryl ester 16:1/16:0 ratio.;Percent change from baseline in plasma cholesteryl ester 16:1/16:0 ratio.;Absolute change from baseline in disease-specific biomarkers;Percentage change from baseline in disease-specific biomarkers;Absolute change from baseline ??-Hydroxybutyrate and lipid profile;Percent change from baseline ??-Hydroxybutyrate and lipid profile;Maximum observed plasma drug concentration (Cmax);Time to reach maximum observed plasma concentration (tmax);Terminal elimination rate constant, estimated by log-linear least-squares regression of the terminal part of the concentration-time curve (?z);Apparent terminal elimination half-life associated with the terminal slope (?z) of the semi-logarithmic concentration-time curve, estimated as (ln2)/?z (t???z);Area under the plasma concentration-time curve from time zero to 48 hours after dosing (AUC(0-48h));Area under the plasma concentration-curve from time zero to the time of last quantifiable analyte concentration (AUClast);Area under the concentration-time curve from time zero extrapolated to infinity. AUC is estimated by AUClast + Clast/?z where Clast is the last observed quantifiable concentration (AUC);Apparent total body clearance of drug from plasma after extravascular administration calculated as Dose/AUC (CL/F);Mean residence time (MRT);Time delay between drug administration and the first observed concentration in plasma (tlag);Apparent volume of distribution for parent drug at terminal phase (extravascular administration), estimated by dividing the apparent clearance (CL/F) by ?z (Vz/F);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-time curve from time zero extrapolated to infinity divided by the dose administered (AUC/D);Observed maximum plasma concentration divided by the dose administered (Cmax/D);Time of the last quantifiable concentration (tlast);Maximum observed plasma drug concentration at steady state (Cssmax);Minimum observed drug concentration at steady state (Cssmin);Time to reach maximum observed plasma concentration at steady state (tssmax);Area under the concentration-time curve in the dose interval (AUCss);Apparent total body clearance of drug from plasma after extravascular administration calculated as Dose/AUCss (CLss/F);Area under the plasma concentration-time curve from time zero extrapolated to infinity divided by the dose administered (AUCss/D);Observed maximum plasma concentration divided by the dose administered (Cssmax/D);Accumulation ratio based on Cmax (RacCmax);Accumulation ratio based on AUC (RacAUC);Temporal change parameter in systemic exposure (TCP);Amount of analyte excreted into the urine from time t1 to t2 (Ae(t1-t2));Cumulative amount of analyte excreted from time zero through the last sampling interval (Ae(0-last));Fraction of dose excreted unchanged into the urine from time t1 to t2 (fe(t1-t2));Cumulative fraction (%) of dose excreted unchanged into the urine from time zero to the last measured time point (fe(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)
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| Sponsor/Collaborators: |
AstraZeneca
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| Gender: |
All
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| Age: |
18 Years75 Years
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| Phases: |
Phase 1
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| Enrollment: |
60
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| Study Type: |
Interventional
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| Study Designs: |
Allocation: Randomized. Intervention model: Sequential Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
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| Start Date: |
06/07/2020
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| Completion Date: |
--
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| Results First Posted: |
--
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| Last Update Posted: |
24 January 2022
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| Locations: |
United States
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| URL: |
https://clinicaltrials.gov/show/NCT04483947
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