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D005234: Fatty Liver

Developed by Shray Alag, The Harker School
Sections: Correlations, Clinical Trials, and HPO

Correlations computed by analyzing all clinical trials.

Navigate: Clinical Trials and HPO


Correlated Drug Terms (3)


Name (Synonyms) Correlation
drug166 AZD2693 Wiki 0.71
drug3885 TERN-101 Wiki 0.71
drug2916 Placebo Wiki 0.06

Correlated MeSH Terms (3)


Name (Synonyms) Correlation
D065626 Non-alcoholic Fatty Liver Disease NIH 1.00
D008659 Metabolic Diseases NIH 0.35
D050177 Overweight NIH 0.24

Correlated HPO Terms (1)


Name (Synonyms) Correlation
HP:0001397 Hepatic steatosis HPO 1.00

Clinical Trials

Navigate: Correlations   HPO

There are 2 clinical trials


1 A Phase I, Randomized, Single-blind, Placebo-controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD2693 Following Single Ascending Dose Administration in Male and Female Subjects of Non-childbearing Potential in Overweight But Otherwise Healthy Subjects, and Healthy Chinese and Japanese Subjects

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.

NCT04142424
Conditions
  1. Metabolic Disorders
  2. Non-alcoholic Steatohepatitis
Interventions
  1. Drug: AZD2693
  2. Drug: Placebo
MeSH:Fatty Liver Non-alcoholic Fatty Liver Disease Metabolic Diseases Overweight
HPO:Hepatic steatosis

Primary Outcomes

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)

Secondary Outcomes

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-dose

Description: 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-dose

Description: 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-dose

Description: 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-dose

Description: 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-dose

Description: 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-dose

Description: 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-dose

Description: 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-dose

Description: 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-dose

Description: 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-dose

Description: 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-dose

Description: 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-dose

Description: 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-dose

Description: 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-dose

Description: 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-dose

Description: 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-dose

Description: 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-dose

Description: 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-dose

Description: 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-dose

Description: 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-dose
2 A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2a Clinical Trial to Evaluate the Safety, Tolerability, Efficacy, and Pharmacokinetics of Orally Administered TERN-101 Tablets in Adult Patients With Presumed Non-Cirrhotic Non-Alcoholic Steatohepatitis (NASH)

This 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.

NCT04328077
Conditions
  1. NASH - Nonalcoholic Steatohepatitis
Interventions
  1. Drug: TERN-101
  2. Other: Placebo
MeSH:Fatty Liver Non-alcoholic Fatty Liver Disease
HPO:Hepatic steatosis

Primary Outcomes

Measure: Subject incidence of adverse events for TERN-101 versus placebo

Time: 16 weeks

Secondary Outcomes

Measure: Percent change from baseline in ALT for TERN-101 versus placebo at 12 weeks

Time: 12 weeks

Description: Area under the curve

Measure: Plasma concentration of TERN-101 - AUC

Time: 12 weeks

Description: Maximum observed concentration

Measure: Plasma concentration of TERN-101 - Cmax

Time: 12 weeks

Description: Time to reach maximum measured plasma concentration

Measure: Plasma concentration of TERN-101 - Tmax

Time: 12 weeks

Description: Determination of half-life

Measure: Plasma concentration of TERN-101 - t1/2

Time: 12 weeks

HPO Nodes


Reports

Data processed on September 26, 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.

Drug Reports   MeSH Reports   HPO Reports  

Interventions

4,180 reports on interventions/drugs

MeSH

691 reports on MeSH terms

HPO

263 reports on HPO terms

All Terms

Alphabetical index of all Terms

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