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Clinical Trial Summary

The study has been designed to establish the pharmacokinetics (PK) and iron uptake of Ferric Maltol in children and adolescents aged 10-17 years using two (2) lower dose strengths in comparison to the EU-approved 30mg BID dose in adults with IDA in IBD.


Clinical Trial Description

Phase I, open label, randomized, repeat dose, multicentre, pharmacokinetic study to assess the Safety and Tolerability of Ferric Maltol in 3 different dosages. 36 eligible patients will be randomized in a 1:1:1 ratio to one of the following 3 dosages for 9 days BID and a single dose on Day 10: - 30mg ferric maltol capsules - 16.6 mg ferric maltol capsules - 7.8 mg ferric maltol capsules Subject participation in the study will consist of 3 stages: Screening: up to 14 days Treatment period: 10 days treatment period with 2 visits on Day 1 and Day 10 for PK blood sampling. Patients will be randomly allocated to one of the three Ferric Maltol dose groups according to centralized treatment allocation scheme. Post-treatment Safety Follow-up:3-10 days following completion of the treatment period or premature discontinuation of study medication ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03181451
Study type Interventional
Source Shield Therapeutics
Contact
Status Completed
Phase Phase 1
Start date March 14, 2017
Completion date March 28, 2018

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