Iron-refractory, Iron-deficiency Anemia (IRIDA) Clinical Trial
Official title:
Pharmacokinetics and Absolute Bioavailability of Fer-In-Sol (Ferrous Sulfate) and Triferic (Ferric Pyrophosphate Citrate) Administered Orally With Shohl's Solution in Healthy Volunteers
The main purpose is to determine the pharmacokinetics (PK) of Triferic iron administered orally in healthy adult volunteers. It is a randomized multiple treatments, single dose study.
This is a Phase 1/2, randomized multiple treatments, single dose study assessing the
pharmacokinetics (PK) and absolute bioavailability of Fer-In-Sol ( Ferrous Sulfate) and
Triferic (ferric pyrophosphate citrate, or FPC) administered orally with Shohl's solution in
healthy volunteers.
Total participation in the study is approximately six weeks and is comprised of a screening
visit, 6 treatment periods, and a follow-up visit.
The study will be conducted over a 13 day period:
Day 1 will used to determine the baseline serum iron profile for each subject.
Each subject will subsequently receive in a randomized sequence between Day 2 and 10:
1. A single oral dose of Fer-In-Sol at 3 mg Fe/kg body weight (bw).
2. A single oral dose of Oracit Shohl's solution 0.67 mEq/L (0.7 ml/kg bw) followed after
10 minutes by Fer-In-Sol at 3 mg Fe/kg bw
3. a single oral dose of Triferic PO at 3 mg Fe/kg bw
4. a single oral dose of Oracit Shohl's solution 0.67 mEq/L (0.7 ml/kg bw) administered 10
minutes prior to a single oral dose of Triferic at 3 mg Fe/kg bw.
5. a single oral dose of Oracit Shohl's solution 0.67 mEq/L (0.7 ml/kg bw) followed
immediately by a single oral dose of Triferic at 3 mg Fe/kg bw.
All subjects will receive a single dose of 6.6 mg Triferic as a 4 hour IV infusion (to mimic
the 4 hour iron tolerance test) on Day 12.
Blood samples will be obtained at various times to analyze for serum iron parameters and for
safety.
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