| Trial ID: | L0315 |
| Source ID: | NCT02612662
|
| Associated Drug: |
AZD4076
|
| Title: |
A Study to Assess the Safety and Tolerability of Single Doses of AZD4076 in Healthy Male Subjects
|
| Acronym: |
--
|
| Status: |
Active, not recruiting
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
Non-alcoholic Steatohepatitis (NASH)
|
| Interventions: |
Drug: AZD4076|Drug: Placebo
|
| Outcome Measures: |
The safety and tolerability of AZD4076 by assessment of blood pressure|The safety and tolerability of AZD4076 by assessment of pulse|The safety and tolerability of AZD4076 by assessment of oral temperature|The safety and tolerability of AZD4076 by assessment of electrocardiogram readings|The safety and tolerability of AZD4076 by assessment of digital electrocardiogram readings|The safety and tolerability of AZD4076 by assessment of cardiac telemetry|The safety and tolerability of AZD4076 by assessment of physical examination|The safety and tolerability of AZD4076 by assessing hematology|The safety and tolerability of AZD4076 by assessing the injection site|The safety and tolerability of AZD4076 by assessming the number of adverse events|The safety and tolerability of AZD4076 by assessing clinical chemistry|The safety and tolerability of AZD4076 by assessing urinalysis|The safety and tolerability of AZD4076 by assessing the number of participants with adverse events|Observed maximum plasma concentration, taken directly from the individual concentration-time curve [Cmax] assessed for AZD4076 from the plasma data|Time to reach maximum concentration, taken directly from the individual concentration-time curve [tmax] assessed for AZD4076 from the plasma data|Terminal elimination half-life, estimated as (ln2)/??z [t1/2??z ] assessed for AZD4076 from the plasma data|Area under the plasma concentration-curve from time zero to 72h after drug administration [AUC(0-72h)] assessed for AZD4076 from the plasma data|Area under the plasma concentration-curve from time zero to the time of last quantifiable concentration [AUC(0-last)] assessed for AZD4076 from the plasma data|Area under plasma concentration-time curve from time zero extrapolated to infinity [AUC] assessed for AZD4076 from the plasma data|Apparent total clearance, estimated as dose divided by AUC [CL/F] assessed for AZD4076 from the plasma data|Mean Residence Time [MRT] assessed for AZD4076 from the plasma data|Apparent volume of distribution at terminal phase, estimated by dividing the apparent clearance (CL/F) by ??z [Vz/F] assessed for AZD4076 from the plasma data|Dose normalized maximum plasma concentration divided by dose, calculated by dividing Cmax by the dose administered for [Cmax/D] assessed for AZD4076 from the plasma data|Dose normalized area under the plasma concentration-time curve from time zero to time of last quantifiable concentration, calculated by dividing AUC(0-last) by the dose administered [AUC(0 last)/D] assessed for AZD4076 from the plasma data|Dose normalized area under the plasma concentration-time curve from time zero extrapolated to infinity divided by dose, calculated by dividing AUC by the dose administered [AUC/D] assessed for AZD4076 from the plasma data|Lag-time, taken directly from the individual concentration-time curve [tlag] assessed for AZD4076 from the plasma data|Cumulative amount of analyte excreted in urine from time zero to the last sampling interval (72 hours) [Ae(0-t)] assessed for AZD4076 from the urine data|Percentage of dose excreted unchanged into the urine from time zero to the last sampling interval (72 hours), estimated by dividing Ae(0-t) by dose [fe(0-t)] assessed for AZD4076 from the urine data|Renal clearance, estimated by dividing Ae(0-t) by AUC(0-72) [CLR] assessed for AZD4076 from the urine data|Cmax assessed for AZD4076 metabolites from the plasma data|tmax assessed for AZD4076 metabolites from the plasma data|t1/2??z assessed for AZD4076 metabolites from the plasma data|AUC(0-last) assessed forAZD4076 metabolites from the plasma data|AUC(0-72h) assessed for AZD4076 metabolites from the plasma data|MRT assessed for AZD4076 metabolites from the plasma data|tlag assessed for AZD4076 metabolites from the plasma data|Vz/F assessed for AZD4076 metabolites from the plasma data|Cmax/D assessed for AZD4076 metabolites from the plasma data|[AUC(0-last)/D assessed for AZD4076 metabolites from the plasma data|AUC/D assessed for AZD4076 metabolites from the plasma data|Ae(0-t) assessed for AZD4076 metabolites from the urine data|fe(0-t) assessed for AZD4076 metabolites from the urine data|CLR assessed for AZD4076 metabolites from the urine data|AUC assessed for AZD4076 metabolites from the plasma data|CL/F assessed for AZD4076 metabolites from the plasma data
|
| Sponsor/Collaborators: |
AstraZeneca
|
| Gender: |
Male
|
| Age: |
18 Years to 50 Years ?? (Adult)
|
| Phases: |
Phase 1
|
| Enrollment: |
40
|
| Study Type: |
Interventional
|
| Study Designs: |
Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Participant)|Primary Purpose: Basic Science
|
| Start Date: |
November 24, 2015
|
| Completion Date: |
February 22, 2022
|
| Results First Posted: |
--
|
| Last Update Posted: |
December 14, 2021
|
| Locations: |
Research Site, Brooklyn, Maryland, United States
|
| URL: |
https://ClinicalTrials.gov/show/NCT02612662
|
