Iron deficiency (with or without anaemia) MedDRA version: 20.0 Level: PT Classification code 10022972 Term: Iron deficiency anaemia System Organ Class: 10005329 - Blood and lymphatic system disorders MedDRA version: 20.0 Level: LLT Classification code 10002062 Term: Anaemia iron deficiency System Organ Class: 100000012842
Conditions
Interventions
Trade Name: Feraccru
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Ferric maltol
CAS Number: 33725-54-1
Current Sponsor code:
Sponsors
Shield TX (UK) Limited
Eligibility
Sex/Gender
All
Inclusion 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 IEC approved assent forms 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 =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 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 excluded at the Investigators discretion. 14.Scheduled or expected hospitalization 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 efficacy 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the pharmacokinetics (PK) and iron uptake of Ferric Maltol (ST10) in children and adolescents (aged 10-17 years) after twice daily [BID] oral doses of 7.8 mg, 16.6mg or 30 mg for 9 days (Days 1 to 9) and a single morning dose on Day 10, through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.; Secondary Objective: 1.To assess the effect of 7.8 mg, 16.6 mg or 30 mg Ferric Maltol in children and adolescents (aged 10-17 years) after twice daily oral doses for 9 days (Days 1 to 9) and a single morning dose on Day 10, on serum transferrin, total and unsaturated iron binding capacity (TIBC, UIBC), ferritin, non-transferrin bound iron (NTBI); routine haematology indices, including absolute reticulocyte count, in blood. 2.To assess the safety and tolerability of 7.8 mg, 16.6 mg or 30 mg Ferric Maltol in children and adolescents (aged 10-17 years) after twice daily oral doses for 9 days (Days 1 to 9) and a single morning dose on Day 10, based upon vital signs, adverse events, concomitant medications, 12-lead ECG and clinical laboratory safety blood tests. ; Primary end point(s): 1.Population PK analysis of maltol and maltol glucuronide in plasma from PK samples collected on Day 1 (after first morning dose) and Day 10 (after last morning dose). Parameters to be derived and reported for each Ferric Maltol dose will be: Cmax, Cave(0-6h), AUC(0-6h), AUC(0-inf) on Day 1 and Day 10, and ratios of Day 10/Day 1 for these parameters. Tmax, half-life (t1/2). Apparent systemic clearance (CL/F), apparent volume of distribution (V/F) Descriptive statistics for plasma concentrations of maltol and maltol glucuronide by time of collection on Day 1 and Day 10 will also be presented, including Ctrough. 2.Descriptive and population PK analysis of serum ir | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1.Descriptive analysis of transferrin, TIBC, UIBC and ferritin concentrations from PK samples collected on Day 1 and Day 10. 2.Descriptive analysis of non-transferrin bound iron (NTBI) concentrations from PK samples collected on Day 1 and Day 10. 3.Descriptive analysis of haemoglobin concentration and absolute reticulocyte count from haematology samples collected at Screening and Day 10. 4.Treatment-emergent Adverse Events (AEs) will be summarised. 5.Treatment-emergent Serious Adverse Events (SAEs) will be summarised. 6.Treatment-emergent Adverse Events leading to premature discontinuation of study drug/PK assessments will be summarised. 7.Clinical laboratory safety blood results at Screening and Day 10 will be summarised. 8.Changes in vital signs and 12-lead ECG will be summarised. 9.Concomitant medications will be summarised. ;Timepoint(s) of evaluation of this end point: Sparse sampling; Pre-dose, 0.5-1 hr, 1-2 hr, 2-3 hr, 3-4 hr, 4-6 hr on Day 1 and 10 | — |
Countries
United Kingdom
Contacts
Public ContactClinical operations
Shield TX (UK) Limited
Outcome results
None listed