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Sections: Correlations,
Clinical Trials, and HPO
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Name (Synonyms) | Correlation | |
---|---|---|
drug1248 | Dapagliflozin Wiki | 0.35 |
drug3195 | Placebo Wiki | 0.03 |
Name (Synonyms) | Correlation | |
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D051437 | Renal Insufficiency, NIH | 0.24 |
D051436 | Renal Insufficiency, Chronic NIH | 0.22 |
D006333 | Heart Failure NIH | 0.18 |
Name (Synonyms) | Correlation | |
---|---|---|
HP:0000083 | Renal insufficiency HPO | 0.24 |
HP:0012622 | Chronic kidney disease HPO | 0.22 |
HP:0001635 | Congestive heart failure HPO | 0.18 |
Name (Synonyms) | Correlation | |
---|---|---|
HP:0000077 | Abnormality of the kidney HPO | 0.17 |
Navigate: Correlations HPO
There are 2 clinical trials
This is a single dose, non-randomized, open-label, parallel group study. The study will be conducted in participants with severe renal impairment and compared with matched participants with normal renal function. The duration of the study for an individual participant from Screening to Follow-up will be approximately 5 weeks.
Description: To assess the PK of AZD9977 following administration of AZD9977
Measure: Maximum observed plasma concentration (Cmax) Time: Day 1 to 3 (Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 12, 16, 20, 24, 36, and 48 hours post-dose), Day 4 to 7Description: To assess the PK of AZD9977 following administration of AZD9977
Measure: Area under the plasma concentration-time curve from time zero to infinity (AUC) Time: Day 1 to 3 (Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 12, 16, 20, 24, 36, and 48 hours post-dose), Day 4 to 7Description: To assess the PK of AZD9977 following administration of AZD9977
Measure: Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC0-t) Time: Day 1 to 3 (Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 12, 16, 20, 24, 36, and 48 hours post-dose), Day 4 to 7Description: To assess the PK of AZD9977 following administration of AZD9977
Measure: Time to reach maximum observed plasma concentration (tmax) Time: Day 1 to 3 (Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 12, 16, 20, 24, 36, and 48 hours post-dose), Day 4 to 7Description: To assess the PK of AZD9977 following administration of AZD9977
Measure: Half-life associated with terminal slope of a semi-logarithmic concentration time curve (t½λz) Time: Day 1 to 3 (Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 12, 16, 20, 24, 36, and 48 hours post-dose), Day 4 to 7Description: To assess the PK of AZD9977 following administration of AZD9977
Measure: Terminal elimination rate constant (λz) Time: Day 1 to 3 (Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 12, 16, 20, 24, 36, and 48 hours post-dose), Day 4 to 7Description: To assess the PK of AZD9977 following administration of AZD9977
Measure: Apparent total body clearance of drug from plasma after extravascular administration (CL/F) Time: Day 1 to 3 (Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 12, 16, 20, 24, 36, and 48 hours post-dose), Day 4 to 7Description: To assess the PK of AZD9977 following administration of AZD9977
Measure: Non-renal clearance of drug from plasma after oral administration (CLNR/F) Time: Day 1 to 3 (Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 12, 16, 20, 24, 36, and 48 hours post-dose), Day 4 to 7Description: To assess the PK of AZD9977 following administration of AZD9977
Measure: Apparent volume of distribution during the terminal phase after extravascular administration (Vz/F) Time: Day 1 to 3 (Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 12, 16, 20, 24, 36, and 48 hours post-dose), Day 4 to 7Description: To assess the PK of AZD9977 following administration of AZD9977
Measure: Mean residence time (MRT) Time: Day 1 to 3 (Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 12, 16, 20, 24, 36, and 48 hours post-dose), Day 4 to 7Description: To assess the PK of AZD9977 following administration of AZD9977
Measure: Renal clearance of the drug from plasma (CLR) Time: Day 1 to 3 (Pre-dose, 0-4, 4-8, 8-12, and 12-24 hours post-dose), Day 4 to 7Description: To assess the PK of AZD9977 following administration of AZD9977
Measure: Cumulative amount of unchanged drug excreted into the urine (Ae) Time: Day 1 to 3 (Pre-dose, 0-4, 4-8, 8-12, and 12-24 hours post-dose), Day 4 to 7Description: To assess the PK of AZD9977 following administration of AZD9977
Measure: Fraction of the drug excreted into the urine (fe) Time: Day 1 to 3 (Pre-dose, 0-4, 4-8, 8-12, and 12-24 hours post-dose), Day 4 to 7Description: To evaluate the safety and tolerability of AZD9977
Measure: Number of participants with adverse events and serious adverse events Time: Day -2 to Day 14Description: To determine eGFR based on creatinine and cystatin C using CKD-EPI formula
Measure: Estimated Glomerular Filtration Rate (eGFR) Time: Screening, Day -1, Day 1 to 3 (Pre-dose, 4, 12, 24 , 36, and 48 hours)The purpose of the study is to evaluate the efficacy and safety of AZD9977 alone and AZD9977 in combination with dapagliflozin and to assess the dose-response relationship of placebo, AZD9977 alone, dapagliflozin alone and 3 doses of AZD9977 combined with dapagliflozin on urinary albumin to creatinine ratio (UACR). The study will be conducted in participants with heart failure (HF) with left ventricular ejection fraction (LVEF [below 55%]) and chronic kidney disease (CKD) with estimated glomerular filtration rate (eGFR [between 20 and 60 mL/min, with at least 30% of participants with eGFR <30 mL/min and a maximum of 25% of participants with eGFR >45 mL/min]), including at least 40% of participants with type 2 diabetes mellitus (T2DM).
Description: Evaluating the effect of AZD9977 and dapagliflozin in combination and alone compared with placebo on UACR.
Measure: Percent change from baseline in UACR at 12 weeks Time: Baseline (Day 1) until Week 12 (Day 85)Description: Assessment of the dose-response relationship of placebo, AZD9977 (Dose C) alone, dapagliflozin (10 mg) alone and 3 doses of AZD9977 (A, B or C) combined with dapagliflozin (10 mg) on UACR.
Measure: Percent change from baseline in UACR at 12 weeks to assess dose-response relationship Time: Baseline (Day 1) until Week 12 (Day 85)Description: Assessment of the general safety and tolerability of AZD9977 and dapagliflozin in combination and alone compared with placebo.
Measure: Number of participants with adverse events (AEs) and serious adverse events (SAEs) Time: From baseline (Day 1) until Day 113 (Safety Follow-up)Description: Assessment of the effect of AZD9977 and dapagliflozin in combination and alone compared with placebo on serum potassium.
Measure: Absolute value of serum potassium over time Time: Days 1, and 3 until Day 85Description: Assessment of the effect of AZD9977 and dapagliflozin in combination and alone compared with placebo on serum potassium.
Measure: Change from baseline in serum potassium over time Time: From baseline (Day 1), Day 3 until Day 85Description: Assessment of the effect of AZD9977 and dapagliflozin in combination and alone compared with placebo on eGFR.
Measure: Absolute value of eGFR over time Time: Days 1, and 3 until Day 85Description: Assessment of the effect of AZD9977 and dapagliflozin in combination and alone compared with placebo on eGFR.
Measure: Change from baseline in eGFR over time Time: From baseline (Day 1), Day 3 until Day 85Alphabetical 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.
Drug Reports MeSH Reports HPO Reports