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D018798: Anemia, Iron-Deficiency

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 (4)


Name (Synonyms) Correlation
drug1659 Ferric maltol capsule Wiki 1.00
drug535 BRII-196 Wiki 1.00
drug1660 Ferric maltol suspension Wiki 1.00
Name (Synonyms) Correlation
drug3195 Placebo Wiki 0.04

Correlated MeSH Terms (0)


Name (Synonyms) Correlation

Correlated HPO Terms (1)


Name (Synonyms) Correlation
HP:0001891 Iron deficiency anemia HPO 1.00

Clinical Trials

Navigate: Correlations   HPO

There is one clinical trial.


1 A Randomized, Open-Label, Single Dose, Four-Way Crossover, Phase I Study to Compare the Pharmacokinetics of Ferric Maltol Capsules and Oral Suspension Under Fasted and Fed Conditions in Adult Healthy Volunteers

The purpose of the study is to compare the Pharmacokinetics (PK) of the new ferric maltol suspension, in adults, with the existing ferric maltol capsule.

NCT04626414
Conditions
  1. Anemia, Iron Deficiency
Interventions
  1. Drug: Ferric maltol capsule
  2. Drug: Ferric maltol suspension
MeSH:Anemia, Iron-Deficiency
HPO:Iron deficiency anemia

Primary Outcomes

Description: Ratio of maximum serum concentration (Cmax) of total iron in combined periods of fasted condition between ferric maltol capsule and ferric maltol suspension.

Measure: Ratio of maximum serum concentration (Cmax) of total iron in fasted condition

Time: Pre-dose and 0.15, 0.30, 0.45, 1, 2, 3, 4, 6, 10 and 24 hours post-dose in combined fasted condition

Description: Ratio of maximum serum concentration (Cmax) of total iron in combined periods of fed condition between ferric maltol capsule and ferric maltol suspension

Measure: Ratio of maximum serum concentration (Cmax) of total iron in combined periods of fed condition

Time: Pre-dose and 0.15, 0.30, 0.45, 1, 2, 3, 4, 6, 10 and 24 hours post-dose in combined fed condition

Description: Ratio of area under the curve (AUClast) of total serum iron in combined periods of fasted condition between ferric maltol capsule and ferric maltol suspension

Measure: Ratio of area under the curve (AUClast) of total serum iron in combined period of fasted condition

Time: Pre-dose and 0.15, 0.30, 0.45, 1, 2, 3, 4, 6, 10 and 24 hours post-dose in combined fasted condition

Description: Ratio of area under the curve (AUClast) of total serum iron in combined periods of fed condition between ferric maltol capsule and ferric maltol suspension

Measure: Ratio of area under the curve (AUClast) of total serum iron in combined period of fed condition

Time: Pre-dose and 0.15, 0.30, 0.45, 1, 2, 3, 4, 6, 10 and 24 hours post-dose in combined fed condition

Secondary Outcomes

Description: Descriptive statistics of total serum iron concentration; Area Under the Curve (AUCinf) by formulation (suspension or capsule) and condition (fed and fasted)

Measure: PK analysis of total serum iron concentration; AUCinf in fasted and fed conditions

Time: Pre-dose and 0.15, 0.30, 0.45, 1, 2, 3, 4, 6, 10 and 24 hours post-dose

Description: Descriptive statistics of baseline corrected serum iron concentration; Maximum Concentration (Cmax), by formulation (suspension or capsule) and condition (fed or fasted)

Measure: PK analysis of baseline corrected serum iron concentration; Cmax in fasted and fed conditions

Time: Pre-dose and 0.15, 0.30, 0.45, 1, 2, 3, 4, 6, 10 and 24 hours post-dose

Description: Descriptive statistics of baseline corrected serum iron concentration; area under the Curve from pre-dose to last measurable concentration by formulation (suspension or capsule) and condition (fed or fasted)

Measure: PK analysis of baseline corrected serum iron concentration; AUClast in fasted and fed conditions

Time: Pre-dose and 0.15, 0.30, 0.45, 1, 2, 3, 4, 6, 10 and 24 hours post-dose

Description: Descriptive statistics of baseline corrected serum iron concentration; Area Under the Curve from 0-infinity by formulation (suspension or capsule) and condition (fed or fasted)

Measure: PK analysis of baseline corrected serum iron concentration; AUCinf in fasted and fed conditions

Time: Pre-dose and 0.15, 0.30, 0.45, 1, 2, 3, 4, 6, 10 and 24 hours post-dose

Description: Descriptive statistics of Maximum plasma Concentration (Cmax) of plasma maltol glucuronide by formulation (suspension or capsule) and condition (fed or fasted)

Measure: PK analysis of maltol glucuronide; Cmax in fasted and fed conditions

Time: Pre-dose and 0.15, 0.30, 0.45, 1, 2, 3, 4, 6, 10 and 24 hours post-dose

Description: Descriptive statistics of maltol glucuronide; Area Under the Curve from pre-dose to last measurable concentration by formulation (suspension or capsule) and condition (fed or fasted)

Measure: PK analysis of maltol glucuronide; AUClast in fasted and fed conditions

Time: Pre-dose and 0.15, 0.30, 0.45, 1, 2, 3, 4, 6, 10 and 24 hours post-dose

Description: Descriptive statistics of Maximum plasma Concentration (Cmax) of plasma maltol by formulation (suspension or capsule) and condition (fed or fasted)

Measure: PK analysis of maltol; Cmax in fasted and fed conditions

Time: Pre-dose and 0.15, 0.30, 0.45, 1, 2, 3, 4, 6, 10 and 24 hours post-dose

Description: Descriptive statistics of maltol; Area Under the Curve from pre-dose to last measurable concentration by formulation (suspension or capsule) and condition (fed or fasted)

Measure: PK analysis of maltol; AUClastin fasted and fed conditions

Time: Pre-dose and 0.15, 0.30, 0.45, 1, 2, 3, 4, 6, 10 and 24 hours post-dose

Description: Descriptive statistics of Maximum Concentration (Cmax) of transferrin saturation by formulation (suspension or capsule) and condition (fed or fasted)

Measure: PK analysis of TSAT; Cmax in fasted and fed conditions

Time: Pre-dose and 0.15, 0.30, 0.45, 1, 2, 3, 4, 6, 10 and 24 hours post-dose

Description: Descriptive statistics of transferrin saturation; Area Under the Curve from pre-dose to last measurable concentration by formulation (suspension or capsule) and condition (fed or fasted)

Measure: PK analysis of TSAT; AUClast in fasted and fed conditions

Time: Pre-dose and 0.15, 0.30, 0.45, 1, 2, 3, 4, 6, 10 and 24 hours post-dose

Description: Descriptive statistics of Maximum Concentration (Cmax) of Total Iron Binding Capacity (TIBC) by formulation (suspension or capsule) and condition (fed or fasted)

Measure: PK analysis of TIBC; Cmax in fasted and fed conditions

Time: Pre-dose and 0.15, 0.30, 0.45, 1, 2, 3, 4, 6, 10 and 24 hours post-dose

Description: Descriptive statistics of Total Iron Binding Capacity (TIBC); Area Under the Curve from pre-dose to last measurable concentration by formulation (suspension or capsule) and condition (fed or fasted)

Measure: PK analysis of TIBC; AUClast in fasted and fed conditions

Time: Pre-dose and 0.15, 0.30, 0.45, 1, 2, 3, 4, 6, 10 and 24 hours post-dose

Description: Descriptive statistics of Serious Adverse Events by formulation (suspension or capsule) and condition (fed and fasted)

Measure: Summary of Serious Adverse Events

Time: up to 2 weeks following last dose

Description: Descriptive statistics of Maximum Concentration (Cmax) of Unsaturated Iron Binding Capacity (UIBC) by formulation (suspension or capsule) and condition (fed or fasted)

Measure: PK analysis of UIBC; Cmax in fasted and fed conditions

Time: Pre-dose and 0.15, 0.30, 0.45, 1, 2, 3, 4, 6, 10 and 24 hours post-dose

Description: Descriptive statistics of Unsaturated Iron Binding Capacity (TIBC); Area Under the Curve from pre-dose to last measurable concentration by formulation (suspension or capsule) and condition (fed or fasted)

Measure: PK analysis of UIBC; AUClast in fasted and fed conditions

Time: Pre-dose and 0.15, 0.30, 0.45, 1, 2, 3, 4, 6, 10 and 24 hours post-dose

Description: Descriptive statistics of transferrin; Maximum concentration (Cmax) from pre-dose to last measurable concentration by formulation (suspension or capsule) and condition (fed or fasted)

Measure: PK analysis of transferrin; Cmax in fasted and fed conditions

Time: Pre-dose and 0.15, 0.30, 0.45, 1, 2, 3, 4, 6, 10 and 24 hours post-dose

Description: Descriptive statistics of transferrin; Area Under the Curve from pre-dose to last measurable concentration by formulation (suspension or capsule) and condition (fed or fasted)

Measure: PK analysis of transferrin; AUClast in fasted and fed conditions

Time: Pre-dose and 0.15, 0.30, 0.45, 1, 2, 3, 4, 6, 10 and 24 hours post-dose

Description: Changes in Haemoglobin; change calculated as difference in values measured at Screening, predose and on Day 8, pre-dose by formulation (suspension or capsule) and condition (fed or fasted)

Measure: Changes in Hb from screening to Day 8

Time: Screening to Day 8

Description: Descriptive summary of incidence and casual relationship of treatment-emergent serious adverse events according to MedDRA preferred term (PT) and system organ class (SOC)

Measure: Treatment-Emergent Adverse Events

Time: From first dose of ferric maltol on Day 1 to study completion

Description: Descriptive summary of incidence and casual relationship of treatment-emergent adverse events leading to discontinuation of study drug/PK assessments according to MedDRA preferred term (PT) and system organ class (SOC)

Measure: TEAE leading to premature discontinuation of study drug/PK assessments

Time: From first dose of ferric maltol on Day 1 to study completion

Description: Descriptive statistics for changes in blood pressure from Screening to Day 8

Measure: Vital signs - blood pressure, change from Day 1 to Day 8, Pre-dose

Time: Screening to Day 8

Description: Descriptive statistics for changes in heart rate from Screening to Day 8

Measure: Vital signs - heart rate, change from Day 1 to Day 8, Pre-dose

Time: Screening to Day 8

Description: Number of concomitant medications by formulation (suspension or capsule)

Measure: Summary of concomitant medication by formulation

Time: Day 1 to Day 8 (24 hrs post-dose of last dosing)

HPO Nodes


Reports

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  

Interventions

4,818 reports on interventions/drugs

MeSH

706 reports on MeSH terms

HPO

306 reports on HPO terms

All Terms

Alphabetical index of all Terms

Google Colab

Python example via Google Colab Notebook