NCT03181451

Evaluate the PK, Safety, Tolerability of Ferric Maltol at 3 Dosage Levels in Paediatric Subjects With Iron Deficiency

A Phase 1, Open-Label, Randomised, Repeat Dose, Parallel Group Study to Evaluate the PK, Safety, Tolerability of Ferric Maltol at 3 Dosage Levels in Paediatric Subjects Aged 10-17 Years of Age With Iron Deficiency

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Shield Therapeutics · Industry
• Sex: All
• Age: 10 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

• Iron Deficiency, Anaemia in Children
• Iron-Deficiency

Interventions

Type	Name	Description
DRUG	Ferric Maltol	To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.

Timeline

• Start date: 2017-03-14
• Primary completion: 2018-03-28
• Completion: 2018-03-28
• First posted: 2017-06-08
• Last updated: 2021-10-06
• Results posted: 2020-06-02

Locations

7 sites across 1 country: United Kingdom