Evaluate the PK, Safety, Tolerability of Ferric Maltol at 3 Dosage Levels in Paediatric Subjects With Iron Deficiency
Condition: Iron Deficiency, Anaemia in Children; Iron-Deficiency
MeSH terms: Anemia, Iron-Deficiency; Iron Deficiencies
Intervention: Ferric Maltol
Intervention description: 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.
Intervention MeSH terms: Ferric maltol
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects will be randomized in a 1:1:1 ratio and stratified by co-variates for age and sex. This will ensure that a minimum of 25% of each gender and at least 3 children per age group are enrolled in each Ferric Maltol dose group.
Masking: None (Open Label)
Enrollment: 37.0
Sex: All
Minimum age: 10 Years
Maximum age: 17 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Ability to understand the information given in the Independent Ethics Committee (IEC)
             approved Information Sheet and Consent form. The parent or guardian of the study
             subject must sign and date the informed consent and authorisation to use protected
             health information (PHI) in accordance with national and local subject privacy
             regulations prior to any study mandated procedure. The study participant will be asked
             to provide their assent to participate in the study using the IEC approved Assent
             form.

          2. Willing and able to comply with study requirements.

          3. Age ≥10 to ≤17 years at the time of informed consent and throughout duration of the
             study.

          4. A current diagnosis of iron deficiency (with or without anaemia); iron deficiency
             defined by ferritin <30 µg/L, or ferritin <50 µg/L with transferrin saturation (TSAT)
             <20%, as measured by the central laboratory at the Screening visit (subjects with or
             without anaemia may be enrolled providing Hb is ≥8.5 g/dL as measured at the Screening
             visit).

          5. Where appropriate, female subjects of childbearing potential must agree to use a
             reliable method of contraception until study completion and for at least 4 weeks
             following their final study visit. Reliable contraception is defined as a method which
             results in a low failure rate, i.e., less than 1% per year when used consistently and
             correctly, such as implants, injectables, some intrauterine contraceptive devices
             (IUDs), complete sexual abstinence, a vasectomized partner and oral contraceptive
             medications.

        Exclusion Criteria:

          1. Has untreated or untreatable severe malabsorption syndrome e.g., untreated coeliac
             disease

          2. Has received within 28 days prior to Screening intramuscular or intravenous (IV)
             injection or administration of depot iron preparation.

          3. Has received oral iron supplementation within 7 days prior to Screening

          4. Has received blood transfusion within 12 weeks prior to Screening or is scheduled to
             have blood transfusion or donations during the study period.

          5. Has concomitant disease that would significantly compromise iron absorption or
             absorbed iron utilisation such as swallowing disorders and/or extensive small bowel
             resection.

          6. Has chronic renal disease (eGFR <30mL/min), as assessed at Screening based on serum
             creatinine.

          7. Known hypersensitivity or allergy to either the active substance or excipients of
             Ferric Maltol capsules.

          8. Has a known contraindication for treatment with iron preparations, e.g.
             haemochromatosis, chronic haemolytic disease, sideroblastic anaemia, thalassemia, or
             lead intoxication induced anaemia.

          9. Impaired liver function as indicated by alanine aminotransferase (ALT) or aspartate
             transaminase (AST)>2.0 times upper normal limit as measured at the Screening visit.

         10. Active acute inflammatory disease, including IBD flare or disease exacerbation, which
             in the opinion of the Investigator, is clinically significant.

         11. Active chronic or acute infectious diseases requiring antibiotic treatment.

         12. Pregnant or breast feeding.

         13. Concomitant medical conditions with extensive active bleeding, other than menstrual
             cycles; subjects who suffer from menorrhagia may be included at the Investigator's
             discretion.

         14. Scheduled or expected hospitalisation and/or surgery during the course of the study

         15. Participation in any other interventional clinical study within 28 days prior to
             Screening.

         16. Cardiovascular, liver, renal, hematologic, psychiatric, neurologic, gastrointestinal,
             immunologic, endocrine, metabolic, respiratory or central nervous system disease that,
             in the opinion of the Investigator, may adversely affect the safety of the subject
             and/or objectives of the study drug or severely limit the lifespan of the subject.

         17. Any other unspecified reason that, in the opinion of the Investigator or the Sponsor
             make the subject unsuitable for enrolment.