Iron deficiency anaemia MedDRA version: 16.1 Level: LLT Classification code 10002062 Term: Anaemia iron deficiency System Organ Class: 10005329 - Blood and lymphatic system disorders MedDRA version: 16.1 Level: PT Classification code 10022972 Term: Iron deficiency anaemia System Organ Class: 10005329 - Blood and lymphatic system disorders
Conditions
Interventions
Product Name: ST10-021
Product Code: ST10-021
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: ferric maltol
CAS Number: 33725-54-1
Current Sponsor code: ST10-021
Other descriptive name: 3-hydr
Sponsors
Iron Therapeutics (Switzerland) AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Subject must be competent to understand the information given in the Independent Ethics Committee (IEC) approved information sheet/informed consent form and must sign and date the informed consent prior to any study mandated procedure. •Subject must be willing and able to comply with study requirements. •Subject must be at least 18 years of age, male or female. •Subject must have iron deficiency defined by ferritin =65 years) yes F.1.3.1 Number of subjects for this age range 4
Exclusion criteria
Exclusion criteria: •Has untreated or untreatable severe malabsorption syndrome eg. untreated coeliac disease. •Has had major upper GI surgery; e.g. gastrectomy; gastric bypass or duodenal or jejunal resection; or a swallowing disorder. •Has received within 28 days prior to screening intramuscular or intravenous (IV) injection or administration of depot iron preparation. •Has received prescription or non-prescription oral iron supplementation within 7 days prior to screening. •Has received blood transfusion within 12 weeks prior to screening. •Has received erythropoiesis stimulating agents within 28 days prior to screening . •Serum creatinine >1.5 times the upper limit of normal as measured at the screening visit. •Has a known hypersensitivity or allergy to ST10 or components of the study medication. •Has a known contraindication for treatment with iron preparations, e.g. haemochromatosis, chronic haemolytic disease, sideroblastic anaemia, thalassaemia, or lead intoxication induced anaemia. •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. •Has any other clinically significant abnormalities in pre-study screening laboratory tests, other than those related to a diagnosis of iron deficiency. •Active chronic or acute inflammatory disease including IBD flare or disease exacerbation, which in the opinion of the Investigator, is clinically significant. •Active chronic or acute or infectious diseases requiring antibiotic treatment. •Women who are pregnant or breast feeding. •Concomitant medical conditions with extensive active bleeding, other than menstrual cycles. •Scheduled or expected hospitalisation and/or surgery during the course of the study. •Scheduled blood donations or transfusions during the study period. •Participation in any other interventional clinical study within 12 weeks prior to screening and through to study end; except participation and completion in the ST10-01-301 or 302 studies. Last dose of ST10 in these studies must have been at least 7 days before screening. •History of clinically significant coronary heart disease e.g. unstable angina, heart failure. •Clinically significant neurologic or psychiatric disease resulting in disorientation, memory impairment, or inability to report accurately that might interfere with treatment compliance, study conduct or interpretation of the results (e.g., Alzheimer’s disease, schizophrenia or other psychosis, alcohol or drug abuse). •Has any other medical condition that, in the opinion of the Investigator, may adversely affect the safety of the subject and/or objectives of the study or severely limit the lifespan of the subject. •Is receiving treatment for any active malignancy. •Is an Investigator or any other team member involved directly or indirectly in the conduct of the clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the pharmacokinetics (PK) and iron uptake of ST10 in blood and urine after single and repeated twice [bid] daily oral doses of 30 mg, 60 mg and 90 mg for 8 days in subjects with iron deficiency (with or without anaemia) through measurement of: total serum iron, transferrin saturation [TSAT], plasma and urine concentrations of maltol and maltol glucuronide;Secondary Objective: To evaluate the effect of single and repeated twice [bid] daily oral doses of 30 mg, 60 mg and 90 mg ST10 for 8 days on serum non-transferrin bound iron (NTBI), transferrin, total iron binding capacity [TIBC], ferritin, soluble transferrin receptor, routine haematology indices and reticulocyte haemoglobin concentration (CHr). To evaluate the safety and tolerability of ST10 at the different doses (vital signs, adverse events, concomitant medications). ;Primary end point(s): • Maltol and maltol glucuronide in plasma: Day 1 - Cmax, tmax, AUC(last), AUC(inf), ?z, t½; Day 8 – (last dose) – C0h, Cmax, tmax, AUClast, ?z, t½, Ratio Cmax,Day8/Day 1, Ratio AUClast,Day8/Day 1; • Maltol and maltol glucuronide in urine: Ae0-6h, Ae0-3h, Ae3-6h, Durine0-6h, Durine0-3h, Durine3-6h, CLR; Day 1 and Day 8 • Iron uptake markers in serum (total serum iron, TSAT); Day 1 and Day 8 : descriptive statistics summarised by time point ;Timepoint(s) of evaluation of this end point: Day 1 and Day 8 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Other iron uptake markers in serum on Day 1 and Day 8 (TIBC, transferrin, ferritin, soluble transferrin receptor); routine haematology indices and reticulocyte haemoglobin concentration (CHr) on Day 8: descriptive statistics summarised by time point • NTBI in serum on Day 1 and Day 8: descriptive statistics summarised by time point ;Timepoint(s) of evaluation of this end point: Day 1 and Day 8 | — |
Countries
Germany
Contacts
Public ContactClinical Operations
Iron Therapeutics (UK) Ltd
Outcome results
None listed