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Clinical Trial Details

Trial ID: L0861
Source ID: NCT02636049
Associated Drug: Triferic
Title: Pharmacokinetics of Triferic (Ferric Pyrophosphate Citrate) Administered Intravenously to Healthy Adult Volunteers
Acronym: RMFPC-12
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT02636049/results
Conditions: End Stage Renal Disease
Interventions: DRUG: Triferic
Outcome Measures: Primary: 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., 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., 16 hours | Secondary: Incidence of Treatment Emergent Adverse Events, The number of patients that experienced treatment emergent adverse events will be quantified., 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., 10 - 14 days
Sponsor/Collaborators: Sponsor: Rockwell Medical Technologies, Inc.
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 12
Study Type: INTERVENTIONAL
Study Designs: Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2015-10
Completion Date: 2015-10
Results First Posted: 2019-02-01
Last Update Posted: 2019-08-20
Locations: Jasper Clinic, Kalamazoo, Michigan, 49007, United States
URL: https://clinicaltrials.gov/show/NCT02636049