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Eur J Drug Metab Pharmacokinet. 2017 Apr;42(2):229-238. doi: 10.1007/s13318-016-0334-5.

Randomized Open-Label Phase 1 Study of the Pharmacokinetics of Ferric Maltol in Inflammatory Bowel Disease Patients with Iron Deficiency.

Author information

1
Gastroenterology Practice Minden, Uferstr. 3, 32423, Minden, Germany. bernd.bokemeyer@t-online.de.
2
Krankenhaus Martha-Maria Halle-Dölau, Klinik für Innere Medizin I, Halle (Saale), Germany.
3
Städtisches Klinikum Lüneburg, Ambulanzzentrum Gastroenterologie am Klinikum Lüneburg, Lüneburg, Germany.
4
Schwerpunktpraxis CED, Hamburg, Germany.
5
Gastroenterologische Schwerpunktpraxis, Berlin, Germany.
6
Clinical Development, Shield TX (UK) Limited, Gateshead, UK.

Abstract

BACKGROUND:

Iron deficiency anemia (IDA) is a common complication of inflammatory bowel disease (IBD). Oral ferric maltol improves and normalizes hemoglobin (Hb) in patients with IBD.

AIM:

This open-label, randomized Phase 1 study evaluated the pharmacokinetics of ferric maltol and its effect on iron indices in IBD patients with iron deficiency (with or without anemia).

METHODS:

Iron deficient adult IBD patients received ferric maltol 30, 60, or 90 mg twice daily during an 8-day period. Pharmacokinetics and iron uptake were assessed on days 1 and 8.

RESULTS:

Twenty-four patients were included: 13 with Crohn's disease and 11 with ulcerative colitis (mean age 39 years; 67 % female, mean Hb 13.0 g/dL; mean reticulocyte Hb content (CHr) 31.9 pg; mean ferritin 13.9 µg/L). Plasma maltol and maltol glucuronide increased rapidly at all doses, reaching maximum plasma concentration (C max) 1.0-1.5 h post-dose and declining to baseline after 3-6 h. Maltol and maltol glucuronide exposure (area under the concentration-time curve; AUC) appeared dose proportional with twice-daily dosing, with higher exposure to maltol glucuronide vs. maltol. Mean day 8/day 1 ratios for C max and AUC0-t indicated no accumulation after 7 days of twice-daily dosing. Serum iron and transferrin saturation (TSAT) increased with all doses (maximum values at 1.5-3.0 h post-dose). Serum ferritin and CHr increased by day 8, with greater improvements with 60 and 90 mg twice-daily doses than with 30 mg twice-daily doses.

CONCLUSIONS:

The key constituents of ferric maltol showed predictable pharmacokinetics, with no accumulation over 7 days and increased iron uptake and storage over time at 30-90 mg twice-daily doses.

PMID:
27101422
DOI:
10.1007/s13318-016-0334-5
[Indexed for MEDLINE]

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