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Clinical Trials, and HPO
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| Name (Synonyms) | Correlation | |
|---|---|---|
| drug175 | AZD2693 Wiki | 0.82 |
| drug4269 | TERN-101 Wiki | 0.58 |
| drug3195 | Placebo Wiki | 0.07 |
Navigate: Correlations HPO
There are 3 clinical trials
This Phase 1, first-in-human (FiH), single-ascending-dose (SAD) study, will assess the safety and tolerability and characterize the pharmacokinetics (PK) of AZD2693, following subcutaneous (SC) SAD administration of AZD2693 in male and female subjects of non-childbearing potential in overweight but otherwise healthy subjects, and healthy Chinese and Japanese subjects.
Description: To investigate the safety and tolerability of SC administration of SAD of AZD2693
Measure: Number of subjects experiencing adverse events and serious adverse events Time: From baseline (Day 1) until Day 112 (Week 16, Final follow-up)Description: To characterize the PK of AZD2693 following SC administration of SAD of AZD2693
Measure: Area under the concentration-time curve from time zero extrapolated to infinity (AUC) Time: At Day 1 pre-dose, 0.25 hours [h], 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 12h, 24h, 36h, 48h and 72h post-dose and 1, 2, 4, 8, 12 and 16 weeks post-doseDescription: To characterize the PK of AZD2693 following SC administration of SAD of AZD2693
Measure: Area under the plasma concentration-time curve from time zero to 48 hours after dosing [AUC(0-48h)] Time: At Day 1 pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 12h, 24h, 36h, 48h and 72h post-dose and 1, 2, 4, 8, 12 and 16 weeks post-doseDescription: To characterize the PK of AZD2693 following SC administration of SAD of AZD2693
Measure: Area under the plasma concentration-time curve from time zero to time of last quantifiable analyte concentration divided by the dose administered (AUClast/D) Time: At Day 1 pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 12h, 24h, 36h, 48h and 72h post-dose and 1, 2, 4, 8, 12 and 16 weeks post-doseDescription: To characterize the PK of AZD2693 following SC administration of SAD of AZD2693
Measure: Area under the plasma concentration-curve from time zero to the time of last quantifiable analyte concentration (AUClast) Time: At Day 1 pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 12h, 24h, 36h, 48h and 72h post-dose and 1, 2, 4, 8, 12 and 16 weeks post-doseDescription: To characterize the PK of AZD2693 following SC administration of SAD of AZD2693
Measure: Area under the plasma concentration-time curve from time zero extrapolated to infinity divided by the dose administered (AUC/D) Time: At Day 1 pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 12h, 24h, 36h, 48h and 72h post-dose and 1, 2, 4, 8, 12 and 16 weeks post-doseDescription: To characterize the PK of AZD2693 following SC administration of SAD of AZD2693
Measure: Maximum observed plasma drug concentration (Cmax) of AZD2693 Time: At Day 1 pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 12h, 24h, 36h, 48h and 72h post-dose and 1, 2, 4, 8, 12 and 16 weeks post-doseDescription: To characterize the PK of AZD2693 following SC administration of SAD of AZD2693
Measure: Observed maximum plasma concentration divided by the dose administered (Cmax/D) Time: At Day 1 pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 12h, 24h, 36h, 48h and 72h post-dose and 1, 2, 4, 8, 12 and 16 weeks post-doseDescription: To characterize the PK of AZD2693 following SC administration of SAD of AZD2693
Measure: Time to reach maximum observed concentration following drug administration (tmax) Time: At Day 1 pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 12h, 24h, 36h, 48h and 72h post-dose and 1, 2, 4, 8, 12 and 16 weeks post-doseDescription: To characterize the PK of AZD2693 following SC administration of SAD of AZD2693.
Measure: Apparent terminal elimination half-life associated with the terminal slope (λz) of the semi-logarithmic concentration-time curve, estimated as (ln2)/λz (t½λz) Time: At Day 1 pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 12h, 24h, 36h, 48h and 72h post-dose and 1, 2, 4, 8, 12 and 16 weeks post-doseDescription: To characterize the PK of AZD2693 following SC administration of SAD of AZD2693
Measure: Apparent total body clearance of drug from plasma after extravascular administration calculated as Dose/AUC (CL/F) Time: At Day 1 pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 12h, 24h, 36h, 48h and 72h post-dose and 1, 2, 4, 8, 12 and 16 weeks post-doseDescription: To characterize the PK of AZD2693 following SC administration of SAD of AZD2693
Measure: Apparent volume of distribution for parent drug at terminal phase (extravascular administration), estimated by dividing CL/F by λz (Vz/F) Time: At Day 1 pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 12h, 24h, 36h, 48h and 72h post-dose and 1, 2, 4, 8, 12 and 16 weeks post-doseDescription: To characterize the PK of AZD2693 following SC administration of SAD of AZD2693
Measure: Mean residence time (MRT) Time: At Day 1 pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 12h, 24h, 36h, 48h and 72h post-dose and 1, 2, 4, 8, 12 and 16 weeks post-doseDescription: To characterize the PK of AZD2693 following SC administration of SAD of AZD2693
Measure: Terminal elimination rate constant, estimated by log-linear least-squares regression of the terminal part of the concentration-time curve (λz) Time: At Day 1 pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 12h, 24h, 36h, 48h and 72h post-dose and 1, 2, 4, 8, 12 and 16 weeks post-doseDescription: To characterize the PK of AZD2693 following SC administration of SAD of AZD2693
Measure: Time delay between drug administration and the first observed concentration in plasma (tlag) Time: At Day 1 pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 12h, 24h, 36h, 48h and 72h post-dose and 1, 2, 4, 8, 12 and 16 weeks post-doseDescription: To characterize the PK of AZD2693 following SC administration of SAD of AZD2693
Measure: Time of the last quantifiable concentration (tlast) Time: At Day 1 pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 12h, 24h, 36h, 48h and 72h post-dose and 1, 2, 4, 8, 12 and 16 weeks post-doseDescription: To characterize the PK of AZD2693 following SC administration of SAD of AZD2693
Measure: Cumulative fraction (%) of dose excreted unchanged into the urine from time zero to the last measured time point [fe(0-last)] Time: At Day 1 pre-dose, 0-6h, 6-12h and then 0-12h intervals up to 72h post-doseDescription: To characterize the PK of AZD2693 following SC administration of SAD of AZD2693
Measure: Cumulative amount of analyte excreted into the urine from time zero through the last sampling interval [Ae(0-last)] Time: At Day 1 pre-dose, 0-6h, 6-12h and then 0-12h intervals up to 72h post-doseDescription: To characterize the PK of AZD2693 following SC administration of SAD of AZD2693
Measure: 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] Time: At Day 1 pre-dose, 0-6h, 6-12h and then 0-12h intervals up to 72h post-doseDescription: To characterize the PK of AZD2693 following SC administration of SAD of AZD2693
Measure: Amount of analyte excreted into the urine from time t1 to t2 [Ae(t1-t2)] Time: At Day 1 pre-dose, 0-6h, 6-12h and then 0-12h intervals up to 72h post-doseDescription: To characterize the PK of AZD2693 following SC administration of SAD of AZD2693
Measure: Fraction of dose excreted unchanged into the urine from time t1 to t2 [fe(t1-t2)] Time: At Day 1 pre-dose, 0-6h, 6-12h and then 0-12h intervals up to 72h post-doseThis is a Phase 2, randomized, double-blind, placebo-controlled study designed to evaluate the safety, tolerability, efficacy, and pharmacokinetics (PK) of TERN-101 in non-cirrhotic NASH patients.
Description: Area under the curve
Measure: Plasma concentration of TERN-101 - AUC Time: 12 weeksDescription: Maximum observed concentration
Measure: Plasma concentration of TERN-101 - Cmax Time: 12 weeksDescription: Time to reach maximum measured plasma concentration
Measure: Plasma concentration of TERN-101 - Tmax Time: 12 weeksDescription: Determination of half-life
Measure: Plasma concentration of TERN-101 - t1/2 Time: 12 weeksThis study is intended to investigate the safety and tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of AZD2693, following subcutaneous (SC) administration of multiple ascending doses in patients with Non-alcoholic Steatohepatitis (NASH) with fibrosis Stage 0 to 3 and homozygous for the patatin-like phospholipase domain-containing 3 (PNPLA3) 148M risk allele.
Description: Safety and tolerability will be evaluated in terms of number of participants with adverse events and/or abnormal values of vital signs and/or clinical laboratory and/or electrocardiogram and/or renal assessments and/or blood assessments.
Measure: Number of participants with adverse events Time: Up to 36 weeks (From Screening to Final Visit)Description: The effect of AZD2693 on changes in LFC using magnetic resonance imaging-based proton density fat fraction (MRI-PDFF) compared to placebo will be assessed.
Measure: Absolute change from baseline to Week 8 and Week 12 in liver fat content (LFC) Time: Baseline (Day 1), Week 8, Week 12Description: The effect of AZD2693 on changes in LFC using magnetic resonance imaging-based proton density fat fraction (MRI-PDFF) compared to placebo will be assessed.
Measure: Percent change from baseline to Week 8 and Week 12 in liver fat content (LFC) Time: Baseline (Day 1), Week 8, Week 12Description: The effect of AZD2693 on circulating markers of hepatic health compared to placebo will be assessed.
Measure: Absolute change from baseline in Alanine Aminotransferase Time: Up to 36 weeks (From Screening to Final Visit)Description: The effect of AZD2693 on circulating markers of hepatic health compared to placebo will be assessed.
Measure: Percent change from baseline in Alanine Aminotransferase Time: Up to 36 weeks (From Screening to Final Visit)Description: The effect of AZD2693 on circulating markers of hepatic health compared to placebo will be assessed.
Measure: Absolute change from baseline in Aspartate Aminotransferase Time: Up to 36 weeks (From Screening to Final Visit)Description: The effect of AZD2693 on circulating markers of hepatic health compared to placebo will be assessed.
Measure: Percent change from baseline in Aspartate Aminotransferase Time: Up to 36 weeks (From Screening to Final Visit)Description: The effect of AZD2693 on circulating markers of hepatic health compared to placebo will be assessed.
Measure: Absolute change from baseline in Gamma Glutamyl Transferase Time: Up to 36 weeks (From Screening to Final Visit)Description: The effect of AZD2693 on circulating markers of hepatic health compared to placebo will be assessed.
Measure: Percent change from baseline in Gamma Glutamyl Transferase Time: Up to 36 weeks (From Screening to Final Visit)Description: The effect of AZD2693 on ELF score will be assessed.
Measure: Absolute change from baseline in Enhanced Liver Fibrosis (ELF) score Time: Up to 36 weeks (From Screening to Final Visit)Description: The effect of AZD2693 on ELF score will be assessed.
Measure: Percent change from baseline in ELF score Time: Up to 36 weeks (From Screening to Final Visit)Description: The effect of AZD2693 on cholesteryl ester 16:1/16:0 compared to placebo will be assessed.
Measure: Absolute change from baseline in plasma cholesteryl ester 16:1/16:0 ratio. Time: Days 1, 8, 29, 36, 50, 64, and 78Description: The effect of AZD2693 on cholesteryl ester 16:1/16:0 compared to placebo will be assessed.
Measure: Percent change from baseline in plasma cholesteryl ester 16:1/16:0 ratio. Time: Days 1, 8, 29, 36, 50, 64, and 78Description: The effect of AZD2693 on disease-specific biomarkers compared to placebo will be assessed.
Measure: Absolute change from baseline in disease-specific biomarkers Time: Days 1, 8, 29, 36, 50, 64, and 78Description: The effect of AZD2693 on disease-specific biomarkers compared to placebo will be assessed.
Measure: Percentage change from baseline in disease-specific biomarkers Time: Days 1, 8, 29, 36, 50, 64, and 78Description: To characterise effects of AZD2693 on lipid handling compared to placebo.
Measure: Absolute change from baseline β-Hydroxybutyrate and lipid profile Time: Days 1, 8, 29, 36, 50, 64, and 78Description: To characterise effects of AZD2693 on lipid handling compared to placebo
Measure: Percent change from baseline β-Hydroxybutyrate and lipid profile Time: Days 1, 8, 29, 36, 50, 64, and 78Description: Single dose PK parameters for AZD2693 and AZD2693 full-length antisense oligonucleotides (ASOs) will be derived from plasma concentrations
Measure: Maximum observed plasma drug concentration (Cmax) Time: Day 1 to Day 162Description: Single dose PK parameters for AZD2693 and AZD2693 full-length ASOs will be derived from plasma concentrations
Measure: Time to reach maximum observed plasma concentration (tmax) Time: Day 1 to Day 162Description: Single and multiple dose PK parameters for AZD2693 and AZD2693 full-length ASOs will be derived from plasma concentrations
Measure: Terminal elimination rate constant, estimated by log-linear least-squares regression of the terminal part of the concentration-time curve (λz) Time: Day 1 to Day 162Description: Single and multiple dose PK parameters for AZD2693 and AZD2693 full-length ASOs will be derived from plasma concentrations
Measure: Apparent terminal elimination half-life associated with the terminal slope (λz) of the semi-logarithmic concentration-time curve, estimated as (ln2)/λz (t½λz) Time: Day 1 to Day 162Description: Single and multiple dose PK parameters for AZD2693 and AZD2693 full-length ASOs will be derived from plasma concentrations
Measure: Area under the plasma concentration-time curve from time zero to 48 hours after dosing (AUC(0-48h)) Time: Day 1 to Day 162Description: Single and multiple dose PK parameters for AZD2693 and AZD2693 full-length antisense oligonucleotides (ASOs) will be derived from plasma concentrations
Measure: Area under the plasma concentration-curve from time zero to the time of last quantifiable analyte concentration (AUClast) Time: Day 1 to Day 162Description: Single dose PK parameters for AZD2693 and AZD2693 full-length ASOs will be derived from plasma concentrations
Measure: Area under the concentration-time curve from time zero extrapolated to infinity. AUC is estimated by AUClast + Clast/λz where Clast is the last observed quantifiable concentration (AUC) Time: Day 1 to Day 162Description: Single dose PK parameters for AZD2693 and AZD2693 full-length ASOs will be derived from plasma concentrations
Measure: Apparent total body clearance of drug from plasma after extravascular administration calculated as Dose/AUC (CL/F) Time: Day 1 to Day 162Description: Single and multiple dose PK parameters for AZD2693 and AZD2693 full-length antisense oligonucleotides (ASOs) will be derived from plasma concentrations
Measure: Mean residence time (MRT) Time: Day 1 to Day 162Description: Single and multiple dose PK parameters for AZD2693 and AZD2693 full-length ASOs will be derived from plasma concentrations
Measure: Time delay between drug administration and the first observed concentration in plasma (tlag) Time: Day 1 to Day 162Description: Single dose PK parameters for AZD2693 and AZD2693 full-length ASOs will be derived from plasma concentrations
Measure: Apparent volume of distribution for parent drug at terminal phase (extravascular administration), estimated by dividing the apparent clearance (CL/F) by λz (Vz/F) Time: Day 1 to Day 162Description: Single and multiple dose PK parameters for AZD2693 and AZD2693 full-length ASOs will be derived from plasma concentrations
Measure: Area under the plasma concentration-time curve from time zero to time of last quantifiable analyte concentration divided by the dose administered (AUClast/D) Time: Day 1 to Day 162Description: Single dose PK parameters for AZD2693 and AZD2693 full-length ASOs will be derived from plasma concentrations
Measure: Area under the plasma concentration-time curve from time zero extrapolated to infinity divided by the dose administered (AUC/D) Time: Day 1 to Day 162Description: Single dose PK parameters for AZD2693 and AZD2693 full-length ASOs will be derived from plasma concentrations
Measure: Observed maximum plasma concentration divided by the dose administered (Cmax/D) Time: Day 1 to Day 162Description: Single and multiple dose PK parameters for AZD2693 and AZD2693 full-length ASOs will be derived from plasma concentrations
Measure: Time of the last quantifiable concentration (tlast) Time: Day 1 to Day 162Description: Multiple dose PK parameters for AZD2693 and AZD2693 full-length ASOs will be derived from plasma concentrations
Measure: Maximum observed plasma drug concentration at steady state (Cssmax) Time: Day 1 to Day 162Description: Multiple dose PK parameters for AZD2693 and AZD2693 full-length ASOs will be derived from plasma concentrations
Measure: Minimum observed drug concentration at steady state (Cssmin) Time: Day 1 to Day 162Description: Multiple dose PK parameters for AZD2693 and AZD2693 full-length ASOs will be derived from plasma concentrations
Measure: Time to reach maximum observed plasma concentration at steady state (tssmax) Time: Day 1 to Day 162Description: Multiple dose PK parameters for AZD2693 and AZD2693 full-length ASOs will be derived from plasma concentrations
Measure: Area under the concentration-time curve in the dose interval (AUCss) Time: Day 1 to Day 162Description: Multiple dose PK parameters for AZD2693 and AZD2693 full-length ASOs will be derived from plasma concentrations
Measure: Apparent total body clearance of drug from plasma after extravascular administration calculated as Dose/AUCss (CLss/F) Time: Day 1 to Day 162Description: Multiple dose PK parameters for AZD2693 and AZD2693 full-length ASOs will be derived from plasma concentrations
Measure: Area under the plasma concentration-time curve from time zero extrapolated to infinity divided by the dose administered (AUCss/D) Time: Day 1 to Day 162Description: Multiple dose PK parameters for AZD2693 and AZD2693 full-length ASOs will be derived from plasma concentrations
Measure: Observed maximum plasma concentration divided by the dose administered (Cssmax/D) Time: Day 1 to Day 162Description: Multiple dose PK parameters for AZD2693 and AZD2693 full-length ASOs will be derived from plasma concentrations
Measure: Accumulation ratio based on Cmax (RacCmax) Time: Day 1 to Day 162Description: Multiple dose PK parameters for AZD2693 and AZD2693 full-length ASOs will be derived from plasma concentrations
Measure: Accumulation ratio based on AUC (RacAUC) Time: Day 1 to Day 162Description: Multiple dose PK parameters for AZD2693 and AZD2693 full-length ASOs will be derived from plasma concentrations
Measure: Temporal change parameter in systemic exposure (TCP) Time: Day 1 to Day 162Description: Urine PK parameters for AZD2693 full-length ASOs will be derived from the urine data
Measure: Amount of analyte excreted into the urine from time t1 to t2 (Ae(t1-t2)) Time: Day 1 and Day 57: Pre-dose and between 0-6 hours, 6-12 hours, 12-24 hours, 24-36 hours and 36-48 hours post-doseDescription: Urine PK parameters for AZD2693 full-length ASOs will be derived from the urine data
Measure: Cumulative amount of analyte excreted from time zero through the last sampling interval (Ae(0-last)) Time: Day 1 and Day 57: Pre-dose and between 0-6 hours, 6-12 hours, 12-24 hours, 24-36 hours and 36-48 hours post-doseDescription: Urine PK parameters for AZD2693 full-length ASOs will be derived from the urine data
Measure: Fraction of dose excreted unchanged into the urine from time t1 to t2 (fe(t1-t2)) Time: Day 1 and Day 57: Pre-dose and between 0-6 hours, 6-12 hours, 12-24 hours, 24-36 hours and 36-48 hours post-doseDescription: Urine PK parameters for AZD2693 full-length ASOs will be derived from the urine data
Measure: Cumulative fraction (%) of dose excreted unchanged into the urine from time zero to the last measured time point (fe(0-last)) Time: Day 1 and Day 57: Pre-dose and between 0-6 hours, 6-12 hours, 12-24 hours, 24-36 hours and 36-48 hours post-doseDescription: Urine PK parameters for AZD2693 full-length ASOs will be derived from the urine data
Measure: 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) Time: Day 1 and Day 57: Pre-dose and between 0-6 hours, 6-12 hours, 12-24 hours, 24-36 hours and 36-48 hours post-doseAlphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
Data processed on December 13, 2020.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.
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