AEGIS Kids PK (ST10-01-103)
Research type
Research Study
Full title
A Phase 1, Open-Label, Randomised, Repeat Dose, Parallel Group Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Ferric Maltol at Three Dosage Levels in Paediatric Subjects aged 10-17 years of age with iron deficiency (with or without anaemia)
IRAS ID
218042
Contact name
Stephen Allen
Contact email
Sponsor organisation
Shield TX (UK) Limited
Eudract number
2016-002192-10
Duration of Study in the UK
0 years, 9 months, 0 days
Research summary
There is an unmet need for an alternative oral (by mouth) treatment for iron deficiency in children and teenagers, and too avoid the need for intravenous therapy. In children, iron deficiency anaemia (IDA) may cause the following symptoms tiredness, restlessness, attention-deficit/hyperactivity disorder, irritability, growth retardation, and cognitive and intellectual impairment. The existing scientific and clinical experience with ferric maltol in the treatment of IDA in patients with inflammatory bowel disorder (IBD) supports its further investigation in the treatment of iron deficiency/IDA in children and teenagers. Data from this pharmacokinetics study in children and teenagers will be used to select the dose(s) for a subsequent Phase 3 paediatric study of Ferric Maltol in the treatment of IDA.
Ferric Maltol is being developed by Shield TX (UK) Ltd., as a new type of oral (by mouth) treatment for iron deficiency treatment where the iron is surrounded by maltol molecules. Maltol is a natural sugar often used as a food additive. Ferric maltol makes more iron available in the stomach and intestines. As there is more iron available in the system for the body to absorb, the study drug can ease anaemia symptoms in iron deficiency anaemic patients.
The purpose of this study is to understand the absorption of iron and absorption and elimination (removal) of maltol in children and teenagers. Thirty-six participants in the UK (males and females 10-17 years of age) with iron deficiency will be recruited in the study.REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
16/WM/0512
Date of REC Opinion
23 Jan 2017
REC opinion
Further Information Favourable Opinion