Conditions: Iron-refractory, Iron-deficiency Anemia (IRIDA)
Keywords: pharmacokinetics healthy adult volunteer
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 14
Healthy volunteers: yes

Brief summary:
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.

Detailed description:
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.

Arms:
arm 1: Patients will receive A single oral dose of Fer-In-Sol at 3 mg Fe/kg body weight (bw). arm 2: Patients will receive a single oral dose of Oracit Shohl's solution 0.67 mEq/L (0.7ml/kg bw) followed after 10 minutes by Fer-In-Sol at 3 mg Fe/kg bw. arm 3: Patients will receive a single oral dose of Triferic at 3 mg Fe/kg bw. arm 4: Patients will receive 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. arm 5: Patients will receive 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. arm 6: Patients will receive IV Triferic iron 6.6 mg diluted in an appropriate amount of D5W administered as a 120 mL infusion intravenously for 4 hours. arm 7: baseline serum iron profile will be determined for each patient. no study drug will be administered.

Interventions: intervention 1: Triferic intervention 2: Fer-In-Sol intervention 3: Shohl's solution
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol document: