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Pharmacokinetics of Triferic (Ferric Pyrophosphate Citrate) Administered Intravenously to Healthy Adult Volunteers (RMFPC-12)

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ClinicalTrials.gov Identifier: NCT02636049
Recruitment Status : Completed
First Posted : December 21, 2015
Results First Posted : February 1, 2019
Last Update Posted : August 20, 2019
Sponsor:
Information provided by (Responsible Party):
Rockwell Medical Technologies, Inc.

Tracking Information
First Submitted Date  ICMJE December 15, 2015
First Posted Date  ICMJE December 21, 2015
Results First Submitted Date  ICMJE September 27, 2017
Results First Posted Date  ICMJE February 1, 2019
Last Update Posted Date August 20, 2019
Study Start Date  ICMJE October 2015
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 27, 2018)
  • Pharmacokinetics of Triferic Iron Administered IV to Healthy Adults: Maximum Drug Concentration (Cmax) of Total Serum Iron [ Time Frame: 16 hours ]
    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.
  • 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 [ Time Frame: 16 hours ]
    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.
Original Primary Outcome Measures  ICMJE
 (submitted: December 16, 2015)
  • Pharmacokinetics of Triferic iron 6 mg administered IV to healthy adults: Cmax of transferrin-bound iron and total iron [ Time Frame: 16 hours ]
    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) in order to determine the Peak Serum Concentration, Observed (Cmax) of transferrin-bound iron and total iron.
  • Pharmacokinetics of Triferic iron 6 mg administered IV to healthy adults: AUC of transferrin-bound iron and total iron [ Time Frame: 16 hours ]
    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) in order to determine the area under the plasma drug concentration-time curve (AUC) of transferrin-bound iron and total iron.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 27, 2018)
  • Incidence of Treatment Emergent Adverse Events [ Time Frame: 10 - 14 days ]
    The number of patients that experienced treatment emergent adverse events will be quantified.
  • Incidence of Treatment Emergent Serious Adverse Events [ Time Frame: 10 - 14 days ]
    The number of patients that experienced treatment emergent serious adverse events (TESEAs) will be quantified.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 16, 2015)
  • Pharmacokinetics of Triferic iron 35 micrograms/kg administered IV push to healthy adults: Cmax of transferrin-bound iron and total iron [ Time Frame: 16 hours ]
    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 3 (35 micrograms/kg IV push) in order to determine the Peak Serum Concentration, Observed (Cmax) of transferrin-bound iron and total iron.
  • Pharmacokinetics of Triferic iron 35 micrograms/kg administered IV push to healthy adults: AUC of transferrin-bound iron and total iron [ Time Frame: 16 hours ]
    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 3 (35 micrograms/kg IV push) in order to determine the area under the plasma drug-concentration-time curve of transferrin-bound iron and total iron.
  • Incidence of treatment emergent adverse events [ Time Frame: 10 - 14 days ]
    All adverse events that take place from the first dose of Triferic until the follow-up visit or 7 days after the last dose of Triferic (whichever is later) will be recorded.
  • Serum iron profile [ Time Frame: End of each Triferic administration (first on Day 2, t = 3 hours; second on Day 3, t = 30 seconds) ]
    The results of the serum iron profile analyses drawn at the end of each triferic administration will be reviewed.
  • Non-transferrin bound iron [ Time Frame: End of each Triferic administration (first on Day 2, t = 3 hours; second on Day 3, t = 30 seconds) ]
    The results of the non-transferrin bound iron analysis drawn at the end of each triferic administration will be reviewed.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pharmacokinetics of Triferic (Ferric Pyrophosphate Citrate) Administered Intravenously to Healthy Adult Volunteers
Official Title  ICMJE Pharmacokinetics of Triferic (Ferric Pyrophosphate Citrate) Administered Intravenously to Healthy Adult Volunteers
Brief Summary 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.
Detailed Description 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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE End Stage Renal Disease
Intervention  ICMJE Drug: Triferic
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.
Other Names:
  • ferric pyrophosphate citrate
  • FPC
Study Arms  ICMJE
  • Experimental: Treatment Period: 6 mg Triferic IV over 3 hours
    Each subject will receive a single 6 mg dose of Triferic administered as a continuous intravenous infusion over 3 hours on Day 2. The Triferic IV dosing solution will have been prepared by diluting Triferic from ampules (5.44 mg/mL) in an appropriate amount of D5W to a concentration of 0.020 mg/mL. Administration of 300 mL IV at 100 mL/hr for 3 hours results in delivery of 6 mg of Triferic iron.
    Intervention: Drug: Triferic
  • Experimental: Treatment Period: 35 micrograms/kg IV push
    Each subject will receive Triferic as 35 µg/kg body weight IV push over 30-60 seconds on Day 3. The Triferic IV push dosing solution will have been prepared by diluting Triferic from ampules (5.44 mg/mL) in an appropriate amount of D5W to a concentration of 35 µg Triferic iron/kg body weight per subject in 4.5 mL.
    Intervention: Drug: Triferic
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 16, 2015)
12
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2015
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria: Subjects must meet all of the following criteria to be eligible for inclusion in the study:

  1. The subject must be able to provide informed consent and have personally signed and dated the study written informed consent document before completing any study-related procedures.
  2. The subject must be 18-65 years of age inclusive at the time of consent.
  3. The subject must have a transferrin saturation (TSAT) of 15-50% during Screening.
  4. The subject must agree to discontinue all iron preparations for 14 days prior to Baseline.
  5. If the subject is female, she must be premenopausal, non-pregnant and non-lactating, and be at least 90 days post-partum (if applicable) at Screening. Women of childbearing potential must be willing to use appropriate birth control during the entire duration of the study.
  6. The subject must be willing and able to comply with all study procedures and restrictions.
  7. The subject must have no clinically-significant abnormal findings on medical history, vital signs, physical examination, or clinical laboratory results during Screening.
  8. The subject must have a body mass index (BMI) of ≤32.0 kg/m2 at Screening and weigh >60.0 kg.

Exclusion Criteria:

A subject will not be eligible for inclusion in the study if any of the following criteria apply:

  1. The subject has a hemoglobin (Hgb) concentration <13.0 g/dL for men or <12 g/dL for women during Screening.
  2. The subject has a total iron binding capacity (TIBC) <250 µg/dL during Screening.
  3. The subject has had administration of IV or oral iron supplements (including multivitamins with iron) within 14 days prior to Baseline.
  4. Subject has concurrent or recurrent disease (e.g., cardiovascular, renal, hepatic, gastrointestinal, malignant, etc.) that could affect the action or disposition of the investigational product utilized in this study, or could affect clinical or laboratory assessments.
  5. Subject has a C-reactive protein level (CRP) >5 mg/L during Screening, or any rheumatic or autoimmune disease that requires systemic anti-inflammatory or immunomodulatory therapy.
  6. Subject has an acute illness within 14 days prior to Baseline.
  7. Subject has known or suspected intolerance or hypersensitivity to iron-containing products.
  8. Subject has a history of alcohol or substance abuse within the past year.
  9. Subject has a positive screen for cotinine or drugs of abuse.
  10. Subject is positive for HIV, hepatitis B, or hepatitis C.
  11. Subject uses tobacco in any form (e.g., smoking or chewing) or other nicotine-containing products in any form (e.g., gum, patch, etc.). Ex-users must report that they have stopped using tobacco for at least 30 days prior to Baseline.
  12. Subject donated blood or blood products (e.g., plasma or platelets) within 60 days prior to Baseline.
  13. Subject participated in an investigational drug study within 30 days prior to Baseline.
  14. Subject is pregnant or intends to become pregnant before completing the study.
  15. Subject's current medical status, in the investigator's opinion, would preclude participation in the study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02636049
Other Study ID Numbers  ICMJE RMFPC-12
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Rockwell Medical Technologies, Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Rockwell Medical Technologies, Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Raymond D Pratt, MD FACP Rockwell Medical, Inc
PRS Account Rockwell Medical Technologies, Inc.
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP