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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
14
Jasper Clinic
Kalamazoo, Michigan, United States
Pharmacokinetics (PK) of Total Iron From Triferic Administered Orally in Adult Healthy Patients: Cmax
The outcome will be measured by assessing the Cmax of total iron with multiple different oral iron treatment. The following oral iron dosing treatments will be measured: Treatment A (Fer-in-Sol 3 mg iron/kg), Treatment B (Shohl's solution followed after 10 minutes by Fer-In-Sol, 3 mg/kg), Treatment C (Triferic 3 mg iron/kg), Treatment D (Shohl's solution followed after 10 minutes by Triferic 3 mg/kg), Treatment E (Shohl's solution followed immediately by Triferic 3 mg/kg), Treatment F (Triferic 6.6 mg IV over 4 hours)
Time frame: 0, 1, 2, 4, 6, 8, 12, 16, and 24 hours
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
The number of participants in each treatment group who experienced treatment emergent adverse events will be quantified.
Time frame: 13 days
Number of Participants With Treatment Emergent Serious Adverse Events (TESAEs)
The number of participants in each treatment group who experienced treatment emergent serious adverse events will be quantified.
Time frame: 13 days
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