This is a Phase 1, open-label, three-period sequential dosing study being conducted to determine the pharmacokinetics of Triferic iron administered intravenously (IV) to healthy adults.
This is a Phase 1, open-label, three-period sequential dosing study being conducted primarily to determine the pharmacokinetics of Triferic iron administered intravenously to healthy adults.. Participation will be up to 5 weeks total duration including Screening, Baseline, Treatment Period, and Follow-up. Following Screening, subjects will be admitted to the clinic on Day -1, prior to Baseline (Day 1). During the Treatment Period, subjects will receive two doses of Triferic. Each subject will receive a single 6-mg dose of Triferic administered IV over 3 hours (hr) on one day (Day 2), and a single 35-µg/kg dose of Triferic administered IV push the following day (Day 3). On Day 4, subjects will be discharged from the clinic and will return approximately one week later for their final Follow-up visit.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Triferic is supplied as sterile 5 mL ampules containing 5.44 mg/mL of iron in water for injection. Each 5 mL ampule contains 27.2 mg of Triferic iron.
Jasper Clinic
Kalamazoo, Michigan, United States
Pharmacokinetics of Triferic Iron Administered IV to Healthy Adults: Maximum Drug Concentration (Cmax) of Total Serum Iron
Blood samples will be drawn at time = 0, 1, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 12, and 16 hours after the start of Triferic administration on study Day 2 (IV infusion of 6 mg Triferic over 3 hours) and Day 3 (35 microgram/kg IV dose of Triferic given over 30 - 60 seconds) in order to determine the Peak Serum Concentration, corrected (Cmax) of total serum iron.
Time frame: 16 hours
Pharmacokinetics of Triferic Iron Administered IV to Healthy Adults: Area Under the Serum Iron Concentration Time Curve From Time Zero to the Time of Last Quantified Concentration (AUC(Last)) of Total Serum Iron
Blood samples will be drawn at time = 0, 1, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 12, and 16 hours after the start of Triferic administration on study Day 2 (IV infusion of 6 mg Triferic over 3 hours) and study day 3 (35 microgram/kg IV Triferic dose administered in 30 - 60 seconds) in order to determine the AUC(last) of total serum iron.
Time frame: 16 hours
Incidence of Treatment Emergent Adverse Events
The number of patients that experienced treatment emergent adverse events will be quantified.
Time frame: 10 - 14 days
Incidence of Treatment Emergent Serious Adverse Events
The number of patients that experienced treatment emergent serious adverse events (TESEAs) will be quantified.
Time frame: 10 - 14 days
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