drugset / Trial / NCT03181451

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

NCT03181451

Phase 1 Completed 37 enrolled Shield Therapeutics Medpace, Inc. · collab
RandomizedParallel-groupOpen-labelOther

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.

Timeline

Start
2017-03-14
Primary completion
2018-03-28
Completion
2018-03-28

Drugs

EvaluationDrugModalityDoseRoute
Comparator Ferric maltol Small molecule 7.8 mg
Comparator Ferric maltol Small molecule 16.6 mg
Comparator Ferric maltol Small molecule 30 mg